Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (NCT NCT04537923)
NCT ID: NCT04537923
Last Updated: 2023-11-02
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1428 participants
Primary outcome timeframe
Baseline, Week 52
Results posted on
2023-11-02
Participant Flow
Participant milestones
| Measure |
5 mg Tirzepatide
Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
|
10 mg Tirzepatide
Participants received 10 mg tirzepatide administered SC once a week .
|
15 mg Tirzepatide
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
Participants received Insulin lispro 100 units per milliliter (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
243
|
238
|
236
|
711
|
|
Overall Study
Received at Least One Dose of Study Drug
|
243
|
238
|
236
|
708
|
|
Overall Study
COMPLETED
|
228
|
228
|
225
|
623
|
|
Overall Study
NOT COMPLETED
|
15
|
10
|
11
|
88
|
Reasons for withdrawal
| Measure |
5 mg Tirzepatide
Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
|
10 mg Tirzepatide
Participants received 10 mg tirzepatide administered SC once a week .
|
15 mg Tirzepatide
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
Participants received Insulin lispro 100 units per milliliter (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
4
|
|
Overall Study
Death
|
3
|
3
|
1
|
11
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
6
|
|
Overall Study
Physician Decision
|
1
|
0
|
2
|
5
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
4
|
58
|
|
Overall Study
Missed study visits
|
2
|
0
|
0
|
3
|
|
Overall Study
Sponsor's decision
|
0
|
0
|
1
|
1
|
|
Overall Study
Safety reasons
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin
Baseline characteristics by cohort
| Measure |
5 mg Tirzepatide
n=243 Participants
Participants received 5 mg tirzepatide administered SC once a week.
|
10 mg Tirzepatide
n=238 Participants
Participants received 10 mg tirzepatide administered SC once a week.
|
15 mg Tirzepatide
n=236 Participants
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=711 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
Total
n=1428 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.00 years
STANDARD_DEVIATION 10.18 • n=99 Participants
|
59.60 years
STANDARD_DEVIATION 9.41 • n=107 Participants
|
58.20 years
STANDARD_DEVIATION 9.62 • n=206 Participants
|
59.00 years
STANDARD_DEVIATION 9.74 • n=7 Participants
|
58.80 years
STANDARD_DEVIATION 9.75 • n=31 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
398 Participants
n=7 Participants
|
824 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
313 Participants
n=7 Participants
|
604 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
148 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
149 Participants
n=206 Participants
|
446 Participants
n=7 Participants
|
885 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
261 Participants
n=7 Participants
|
536 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
230 Participants
n=99 Participants
|
224 Participants
n=107 Participants
|
220 Participants
n=206 Participants
|
671 Participants
n=7 Participants
|
1345 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Argentina
|
70 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
207 Participants
n=7 Participants
|
417 Participants
n=31 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Region of Enrollment
Brazil
|
47 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
141 Participants
n=7 Participants
|
281 Participants
n=31 Participants
|
|
Region of Enrollment
Czechia
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=31 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Region of Enrollment
Greece
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Region of Enrollment
Hungary
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Region of Enrollment
Mexico
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
118 Participants
n=31 Participants
|
|
Region of Enrollment
Romania
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=31 Participants
|
|
Region of Enrollment
Russia
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
107 Participants
n=31 Participants
|
|
Region of Enrollment
Slovakia
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
83 Participants
n=31 Participants
|
|
Region of Enrollment
Spain
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Region of Enrollment
Turkey
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
85 Participants
n=7 Participants
|
169 Participants
n=31 Participants
|
|
Hemoglobin A1c
|
8.89 Percentage of HbA1c
STANDARD_DEVIATION 0.97 • n=99 Participants
|
8.78 Percentage of HbA1c
STANDARD_DEVIATION 0.98 • n=107 Participants
|
8.74 Percentage of HbA1c
STANDARD_DEVIATION 1.01 • n=206 Participants
|
8.81 Percentage of HbA1c
STANDARD_DEVIATION 0.96 • n=7 Participants
|
8.80 Percentage of HbA1c
STANDARD_DEVIATION 0.97 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Pooled 5 mg/10 mg/15 mg Tirzepatide
n=708 Participants
Participants received either 5 mg or 10 mg or 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=692 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
15 mg Tirzepatide
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
|
-2.26 Percentage of HbA1c
Standard Error 0.048
|
-1.16 Percentage of HbA1c
Standard Error 0.049
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Pooled 5 mg/10 mg/15 mg Tirzepatide
n=241 Participants
Participants received either 5 mg or 10 mg or 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=234 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
15 mg Tirzepatide
n=233 Participants
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=692 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Change From Baseline in HbA1c
|
-2.05 Percentage of HbA1c
Standard Error 0.082
|
-2.27 Percentage of HbA1c
Standard Error 0.083
|
-2.46 Percentage of HbA1c
Standard Error 0.084
|
-1.16 Percentage of HbA1c
Standard Error 0.049
|
SECONDARY outcome
Timeframe: Week 52Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
Pooled 5 mg/10 mg/15 mg Tirzepatide
n=242 Participants
Participants received either 5 mg or 10 mg or 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=238 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
15 mg Tirzepatide
n=236 Participants
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=708 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c Target Values <7.0%
|
61.04 Percentage of participants
|
75.64 Percentage of participants
|
79.86 Percentage of participants
|
36.69 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Pooled 5 mg/10 mg/15 mg Tirzepatide
n=241 Participants
Participants received either 5 mg or 10 mg or 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=234 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
15 mg Tirzepatide
n=233 Participants
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=694 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight
|
-6.9 Kilograms (kg)
Standard Error 0.37
|
-9.9 Kilograms (kg)
Standard Error 0.37
|
-12.0 Kilograms (kg)
Standard Error 0.38
|
3.8 Kilograms (kg)
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline metformin Use (Yes, No) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Pooled 5 mg/10 mg/15 mg Tirzepatide
n=241 Participants
Participants received either 5 mg or 10 mg or 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=235 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
15 mg Tirzepatide
n=233 Participants
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=694 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Serum Glucose
|
-33.2 milligram per Deciliter (mg/dL)
Standard Error 3.28
|
-43.0 milligram per Deciliter (mg/dL)
Standard Error 3.32
|
-41.6 milligram per Deciliter (mg/dL)
Standard Error 3.42
|
-10.0 milligram per Deciliter (mg/dL)
Standard Error 1.99
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Pooled 5 mg/10 mg/15 mg Tirzepatide
n=219 Participants
Participants received either 5 mg or 10 mg or 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=210 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
15 mg Tirzepatide
n=204 Participants
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=574 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
|
-56.7 mg/dL/day
Standard Error 1.80
|
-61.5 mg/dL/day
Standard Error 1.85
|
67.6 mg/dL/day
Standard Error 1.86
|
-55.8 mg/dL/day
Standard Error 1.13
|
SECONDARY outcome
Timeframe: Week 52Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
Pooled 5 mg/10 mg/15 mg Tirzepatide
n=241 Participants
Participants received either 5 mg or 10 mg or 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=234 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
15 mg Tirzepatide
n=233 Participants
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=692 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved HbA1c Target Value of <7.0% Without Hypoglycemia
|
52.70 Percentage of participants
|
70.05 Percentage of participants
|
75.12 Percentage of participants
|
13.41 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
Percentage of Participants who Achieved Weight Loss ≥5% is reported here.
Outcome measures
| Measure |
Pooled 5 mg/10 mg/15 mg Tirzepatide
n=242 Participants
Participants received either 5 mg or 10 mg or 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=238 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
15 mg Tirzepatide
n=236 Participants
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=708 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Weight Loss ≥5%
|
64.19 Percentage of participants
|
79.21 Percentage of participants
|
83.15 Percentage of participants
|
6.34 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. PCS score is reported here. PCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by analysis of covariance (ANCOVA) model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Pooled 5 mg/10 mg/15 mg Tirzepatide
n=222 Participants
Participants received either 5 mg or 10 mg or 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=217 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
15 mg Tirzepatide
n=199 Participants
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=599 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
|
1.0 score on a scale
Standard Error 0.46
|
1.7 score on a scale
Standard Error 0.46
|
1.7 score on a scale
Standard Error 0.48
|
-0.6 score on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. MCS consisted of social functioning, vitality, mental health, and role-emotional scales. MCS score is reported here. MCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by ANCOVA model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Pooled 5 mg/10 mg/15 mg Tirzepatide
n=222 Participants
Participants received either 5 mg or 10 mg or 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=217 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
15 mg Tirzepatide
n=199 Participants
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=599 Participants
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score
|
0.3 score on a scale
Standard Error 0.59
|
1.5 score on a scale
Standard Error 0.59
|
0.7 score on a scale
Standard Error 0.62
|
-1.3 score on a scale
Standard Error 0.36
|
Adverse Events
5 mg Tirzepatide
Serious events: 20 serious events
Other events: 94 other events
Deaths: 3 deaths
10 mg Tirzepatide
Serious events: 16 serious events
Other events: 116 other events
Deaths: 3 deaths
15 mg Tirzepatide
Serious events: 17 serious events
Other events: 121 other events
Deaths: 1 deaths
Insulin Lispro
Serious events: 81 serious events
Other events: 99 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
5 mg Tirzepatide
n=243 participants at risk
Participants received 5 mg tirzepatide administered SC once a week.
|
10 mg Tirzepatide
n=238 participants at risk
Participants received 10 mg tirzepatide administered SC once a week.
|
15 mg Tirzepatide
n=236 participants at risk
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=708 participants at risk
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.84%
2/238 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.28%
2/708 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
3/708 • Number of events 3 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
3/708 • Number of events 3 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
3/708 • Number of events 3 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diabetic gastropathy
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Death
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Hypothermia
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bullous erysipelas
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
2/236 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.99%
7/708 • Number of events 7 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.82%
2/243 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.84%
2/238 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
2/236 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.99%
7/708 • Number of events 7 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.28%
2/708 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Diabetic gangrene
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Erysipelas
|
0.82%
2/243 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gangrene
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oophoritis
|
0.00%
0/144 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/149 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/133 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/396 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
2/236 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Septic shock
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.82%
2/243 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
3/238 • Number of events 18 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
28/708 • Number of events 84 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/144 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/149 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/133 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/396 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.28%
2/708 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.28%
2/708 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.28%
2/708 • Number of events 5 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
2/236 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.69%
1/144 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/149 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/133 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/396 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Bipolar disorder
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.28%
2/708 • Number of events 2 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Arthrodesis
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/236 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Retinal cryoablation
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Giant cell arteritis
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.41%
1/243 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/708 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/243 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/236 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
5 mg Tirzepatide
n=243 participants at risk
Participants received 5 mg tirzepatide administered SC once a week.
|
10 mg Tirzepatide
n=238 participants at risk
Participants received 10 mg tirzepatide administered SC once a week.
|
15 mg Tirzepatide
n=236 participants at risk
Participants received 15 mg tirzepatide administered SC once a week.
|
Insulin Lispro
n=708 participants at risk
Participants received Insulin lispro (U100) administered SC three times a day.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.5%
6/243 • Number of events 9 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
8/238 • Number of events 8 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
14/236 • Number of events 19 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.56%
4/708 • Number of events 9 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.9%
29/243 • Number of events 46 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.1%
36/238 • Number of events 66 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.0%
26/236 • Number of events 49 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.4%
17/708 • Number of events 22 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
15/243 • Number of events 16 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.3%
27/238 • Number of events 47 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.4%
27/236 • Number of events 34 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.56%
4/708 • Number of events 4 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
13.6%
33/243 • Number of events 71 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
20.6%
49/238 • Number of events 80 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.8%
61/236 • Number of events 161 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
8/708 • Number of events 11 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
11/243 • Number of events 14 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
21/238 • Number of events 35 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.7%
30/236 • Number of events 80 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.56%
4/708 • Number of events 4 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
11.5%
28/243 • Number of events 28 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.0%
19/238 • Number of events 19 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.9%
21/236 • Number of events 23 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.2%
72/708 • Number of events 73 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.2%
20/243 • Number of events 81 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.8%
28/238 • Number of events 84 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.9%
40/236 • Number of events 128 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/708 • Number of events 1 • Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60