Trial Outcomes & Findings for A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE) (NCT NCT05514535)
NCT ID: NCT05514535
Last Updated: 2026-05-11
Results Overview
Change in HbA1c (Noninferiority) from baseline (Week 0) to end of treatment (Week 40) were reported. Here noninferiority was assessed based on the clinically acceptable margin of 0.3%-point for the mean treatment difference in HbA1c.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
573 participants
Primary outcome timeframe
From baseline (week 0) to end of treatment (week 40)
Results posted on
2026-05-11
Participant Flow
The study was conducted at 140 sites that recruited participants in 9 countries.
A total of 573 participants were randomised in a 1:1 manner to receive either once weekly (OW) semaglutide subcutaneous (s.c.) 2.0 mg and insulin glargine U100 (100 units/mL).
Participant milestones
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
288
|
285
|
|
Overall Study
Safety Analysis Set (SAS)
|
288
|
284
|
|
Overall Study
Full Analysis Set (FAS)
|
288
|
285
|
|
Overall Study
COMPLETED
|
283
|
275
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
Baseline Characteristics
A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)
Baseline characteristics by cohort
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=288 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=285 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
Total
n=573 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.7 Years
STANDARD_DEVIATION 9.7 • n=44 Participants
|
60.5 Years
STANDARD_DEVIATION 10.3 • n=10 Participants
|
61.1 Years
STANDARD_DEVIATION 10.0 • n=30 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=44 Participants
|
129 Participants
n=10 Participants
|
253 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
164 Participants
n=44 Participants
|
156 Participants
n=10 Participants
|
320 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=44 Participants
|
31 Participants
n=10 Participants
|
58 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
261 Participants
n=44 Participants
|
254 Participants
n=10 Participants
|
515 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
33 Participants
n=44 Participants
|
22 Participants
n=10 Participants
|
55 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=44 Participants
|
9 Participants
n=10 Participants
|
19 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
243 Participants
n=44 Participants
|
253 Participants
n=10 Participants
|
496 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From baseline (week 0) to end of treatment (week 40)Population: FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Change in HbA1c (Noninferiority) from baseline (Week 0) to end of treatment (Week 40) were reported. Here noninferiority was assessed based on the clinically acceptable margin of 0.3%-point for the mean treatment difference in HbA1c.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=276 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=272 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Change in Glycated Haemoglobin (HbA1c) [Noninferiority]
|
-1.37 Percentage point of HbA1c
Standard Deviation 0.84
|
-0.65 Percentage point of HbA1c
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of treatment (week 40)Population: FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Change in body weight from baseline (Week 0) to end of treatment (Week 40) were reported. Body weight was measured in unit 'Kilogram (kg)'.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=282 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=275 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Change in Body Weight
|
-7.97 Kilograms
Standard Deviation 5.62
|
0.39 Kilograms
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of treatment (week 40)Population: FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Percentage change in daily insulin dose from baseline (Week 0) to end of treatment (Week 40) were reported. Percentage change from baseline to week 40 in insulin dose (%) was calculated as: (\[insulin dose at week 40\] - \[insulin dose at baseline\]) / \[insulin dose at baseline\] × 100.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=182 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=266 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Percentage Change in Daily Insulin Dose
|
-15.11 Percentage change of daily insulin dose
Standard Deviation 87.25
|
103.42 Percentage change of daily insulin dose
Standard Deviation 142.38
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of treatment (week 40)Population: FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Change in HbA1c (Superiority) from baseline (Week 0) to end of treatment (Week 40) were reported.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=276 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=272 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Change in Glycated Haemoglobin (HbA1c ) [Superiority]
|
-1.37 Percentage-point of HbA1c
Standard Deviation 0.84
|
-0.65 Percentage-point of HbA1c
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: At end of treatment (week 40)Population: FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Score of Diabetes Treatment Satisfaction Questionnaire - change version (DTSQc) at end of treatment (week 40) were reported. The DTSQc provided a measure of how satisfied participants were with their current diabetes treatment compared with previous treatment. It consisted of 8 questions, which were to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint) representing no change. Out of 8 questions, 6 questions related to treatment satisfaction were summed to produce a total score. The DTSQc total treatment satisfaction score ranged from -18 to +18, with higher scores associated with greater treatment satisfaction.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=270 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=262 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)
|
14.69 Score on a scale
Standard Deviation 4.65
|
12.11 Score on a scale
Standard Deviation 6.84
|
SECONDARY outcome
Timeframe: At end of treatment (week 40)Population: FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants achieving Insulin dose = 0 U at the end of treatment (Week 40) were reported.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=288 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=284 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Number of Participants Achieving Insulin Dose = 0 Units/mL (U)
|
37 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (week 40)Population: FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants achieving Insulin dose reduced from baseline by at least 50% by end pf treatment (Week 40) were reported.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=288 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=284 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Number of Participants Achieving Insulin Dose Reduced From Baseline by at Least 50%
|
103 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (week 40)Population: FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants achieving HbA1c \< 7% at the end of treatment (Week 40) were reported.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=285 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=281 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Number of Participants Achieving HbA1c Less Than (<) 7%
|
224 Participants
|
111 Participants
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of treatment (week 40)Population: SAS included all participants who were exposed to study intervention and analyzed according to the intervention they actually received. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to end of treatment (week 40) were reported. Severe hypoglycaemia (level 3) was defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=285 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=281 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Number of Severe Hypoglycaemic Episodes (Level 3)
|
6 Episodes
|
14 Episodes
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of treatment (week 40)Population: SAS included all participants who were exposed to study intervention and analyzed according to the intervention they actually received. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline (week 0) to end of treatment (week 40) were reported. Clinically significant hypoglycaemia (level 2) was defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=285 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=281 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)
|
16 Episodes
|
32 Episodes
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of treatment (week 40)Population: SAS included all participants who were exposed to study intervention and analyzed according to the intervention they actually received. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) from baseline (week 0) to end of treatment (week 40) were reported. Clinically significant hypoglycaemia (level 2) was defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) was defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=285 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=281 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
|
22 Episodes
|
46 Episodes
|
SECONDARY outcome
Timeframe: At end of treatment (week 40)Population: FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Number of Participants achieving HbA1c reduced from baseline by at least 0.3%-points and Insulin dose reduced from baseline, No hypoglycaemic episodes (\< 3.9 mmol/L (70 mg/dL) confirmed by BG meter) and No weight gain at the end of treatment (Week 40) were reported.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=285 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=281 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Number of Participants Achieving HbA1c Reduced From Baseline by at Least 0.3%-Points and Insulin Dose Reduced From Baseline, No Hypoglycaemic Episodes (< 3.9 mmol/L (70 mg/dL) Confirmed by BG Meter) and No Weight Gain
|
138 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of treatment (week 40)Population: FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Score of Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) at end of treatment (week 40) were reported. The status version measures a patient's current satisfaction with treatment using a 0-6 scale for each item; higher scores indicate greater satisfaction with the present treatment (absolute/status level). The DTSQs total treatment satisfaction score ranged from 0 to 36, with higher scores associated with greater treatment satisfaction.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=265 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=262 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)
|
4.56 Score on scale
Standard Deviation 7.04
|
2.17 Score on scale
Standard Deviation 7.04
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of treatment (week 40)Population: FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
Change in SF-36 physical and mental component from baseline (week 0) to end of treatment (Week 40) were presented. SF-36 is self-administered questionnaire that measures each of following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: mental component summary and physical component summary. Physical component summary contains physical functioning, role-physical, bodily pain and general health and mental component summary contain vitality, social functioning, role-emotional and mental health. Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status. A positive change score indicates an improvement since baseline.
Outcome measures
| Measure |
Insuline Glargine U100 (Reduced) + Semaglutide
n=288 Participants
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
Insuline Glargine U100 (Titrated)
n=285 Participants
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Change in Score of Short Form 36 Version 2 (SF-36 v2)
Physical Component Score
|
3.18 Score on a scale
Standard Deviation 7.47
|
0.12 Score on a scale
Standard Deviation 6.67
|
|
Change in Score of Short Form 36 Version 2 (SF-36 v2)
Mental Component Score
|
1.63 Score on a scale
Standard Deviation 9.02
|
0.93 Score on a scale
Standard Deviation 7.39
|
Adverse Events
INSULIN GLARGINE (REDUCED) + SEMAGLUTIDE
Serious events: 17 serious events
Other events: 92 other events
Deaths: 1 deaths
INSULIN GLARGINE (TITRATED)
Serious events: 15 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
INSULIN GLARGINE (REDUCED) + SEMAGLUTIDE
n=288 participants at risk
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
INSULIN GLARGINE (TITRATED)
n=284 participants at risk
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Infections and infestations
Appendicitis
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
General disorders
Asthenia
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.70%
2/284 • Number of events 2 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Infections and infestations
COVID-19
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
General disorders
Chest pain
|
0.69%
2/288 • Number of events 2 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
General disorders
Incarcerated hernia
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Cardiac disorders
Pericarditis
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
General disorders
Peripheral swelling
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Infections and infestations
Pneumonia
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Infections and infestations
Septic shock
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.35%
1/288 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/288 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
Other adverse events
| Measure |
INSULIN GLARGINE (REDUCED) + SEMAGLUTIDE
n=288 participants at risk
Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks.
|
INSULIN GLARGINE (TITRATED)
n=284 participants at risk
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
8.0%
23/288 • Number of events 27 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.00%
0/284 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.3%
21/288 • Number of events 31 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.70%
2/284 • Number of events 2 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.5%
39/288 • Number of events 55 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
4.2%
12/284 • Number of events 14 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Gastrointestinal disorders
Nausea
|
18.4%
53/288 • Number of events 97 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.70%
2/284 • Number of events 2 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
28/288 • Number of events 48 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
0.35%
1/284 • Number of events 1 • From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property
- Publication restrictions are in place
Restriction type: OTHER