Trial Outcomes & Findings for A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes (NCT NCT03952143)
NCT ID: NCT03952143
Last Updated: 2022-02-08
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured 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 Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
628 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2022-02-08
Participant Flow
The study included 8-week lead-in period followed by a 26-week treatment period.
The purpose of the lead-in period (prior to randomization) was to titrate basal insulin, obtain preliminary diagnostic laboratory tests, and determine baseline hypoglycemia rates. Participants were then randomized into the treatment groups in a 2:1 ratio (LY900014:insulin lispro).
Participant milestones
| Measure |
Insulin Lispro (Humalog) Lead-in
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
Insulin Lispro (Humalog)
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|---|
|
Lead-In Period
STARTED
|
628
|
0
|
0
|
|
Lead-In Period
Participants Who Received at Least One Dose
|
628
|
0
|
0
|
|
Lead-In Period
COMPLETED
|
595
|
0
|
0
|
|
Lead-In Period
NOT COMPLETED
|
33
|
0
|
0
|
|
Treatment Period
STARTED
|
0
|
200
|
395
|
|
Treatment Period
Participants Who Received at Least One Dose
|
0
|
200
|
395
|
|
Treatment Period
COMPLETED
|
0
|
191
|
359
|
|
Treatment Period
NOT COMPLETED
|
0
|
9
|
36
|
Reasons for withdrawal
| Measure |
Insulin Lispro (Humalog) Lead-in
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
Insulin Lispro (Humalog)
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|---|
|
Lead-In Period
Adverse Event
|
2
|
0
|
0
|
|
Lead-In Period
Lack of Efficacy
|
2
|
0
|
0
|
|
Lead-In Period
Physician Decision
|
5
|
0
|
0
|
|
Lead-In Period
Protocol Violation
|
5
|
0
|
0
|
|
Lead-In Period
Withdrawal by Subject
|
19
|
0
|
0
|
|
Treatment Period
Adverse Event
|
0
|
0
|
1
|
|
Treatment Period
Lost to Follow-up
|
0
|
2
|
0
|
|
Treatment Period
Physician Decision
|
0
|
0
|
2
|
|
Treatment Period
Protocol Violation
|
0
|
0
|
1
|
|
Treatment Period
Withdrawal by Subject
|
0
|
5
|
26
|
|
Treatment Period
Due to COVID 19 restrictions
|
0
|
2
|
5
|
|
Treatment Period
Participant had taken prohibited concomitant medication
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Insulin Lispro (Humalog)
n=200 Participants
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=395 Participants
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
Total
n=595 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.70 years
STANDARD_DEVIATION 9.48 • n=99 Participants
|
58.30 years
STANDARD_DEVIATION 9.26 • n=107 Participants
|
58.50 years
STANDARD_DEVIATION 9.33 • n=206 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=99 Participants
|
182 Participants
n=107 Participants
|
275 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=99 Participants
|
213 Participants
n=107 Participants
|
320 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
162 Participants
n=99 Participants
|
319 Participants
n=107 Participants
|
481 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
18 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
162 Participants
n=99 Participants
|
319 Participants
n=107 Participants
|
481 Participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
20 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Hemoglobin A1c (HbA1c)
|
7.78 Percentage of HbA1c
STANDARD_DEVIATION 0.88 • n=99 Participants
|
7.73 Percentage of HbA1c
STANDARD_DEVIATION 0.87 • n=107 Participants
|
7.74 Percentage of HbA1c
STANDARD_DEVIATION 0.88 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: All randomized Participants with baseline and at least one post-baseline HbA1c data.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured 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 Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=198 Participants
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=388 Participants
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
|
-0.63 Percentage of HbA1c
Standard Error 0.061
|
-0.56 Percentage of HbA1c
Standard Error 0.046
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants with baseline and at least one post-baseline 1-hour PPG excursion data.
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=178 Participants
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=326 Participants
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
|
100.8 milligrams per deciliter (mg/dL)
Standard Error 4.00
|
86.2 milligrams per deciliter (mg/dL)
Standard Error 3.51
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants with baseline and at least one post-baseline 2-hour PPG excursion data.
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=179 Participants
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=327 Participants
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
2-hour PPG Excursion During MMTT
|
133.2 mg/dL
Standard Error 5.13
|
111.4 mg/dL
Standard Error 4.47
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: All randomized participants who received at least one dose of study drug.
Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group \*36525.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=200 Participants
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=395 Participants
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Rate of Severe Hypoglycemia
|
2.00 Events per 100 participant years
|
0.52 Events per 100 participant years
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: All randomized participants who received at least one dose of study drug.
Documented symptomatic postmeal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL \[3.9 millimole per liter (mmol/L)\]. The rate of documented symptomatic postmeal hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=200 Participants
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=395 Participants
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Rate of Documented Symptomatic Postmeal Hypoglycemia
≤30 minutes post meal
|
0.13 Events per participant per year
Standard Error 0.033
|
0.11 Events per participant per year
Standard Error 0.020
|
|
Rate of Documented Symptomatic Postmeal Hypoglycemia
≤1 hour post meal
|
0.25 Events per participant per year
Standard Error 0.057
|
0.34 Events per participant per year
Standard Error 0.053
|
|
Rate of Documented Symptomatic Postmeal Hypoglycemia
>1 to ≤2 hours post meal
|
0.67 Events per participant per year
Standard Error 0.109
|
1.07 Events per participant per year
Standard Error 0.145
|
|
Rate of Documented Symptomatic Postmeal Hypoglycemia
≤2 hours post meal
|
0.92 Events per participant per year
Standard Error 0.137
|
1.41 Events per participant per year
Standard Error 0.169
|
|
Rate of Documented Symptomatic Postmeal Hypoglycemia
>2 to ≤4 hours post meal
|
1.96 Events per participant per year
Standard Error 0.276
|
1.92 Events per participant per year
Standard Error 0.214
|
|
Rate of Documented Symptomatic Postmeal Hypoglycemia
≤4 hours post meal
|
2.89 Events per participant per year
Standard Error 0.351
|
3.32 Events per participant per year
Standard Error 0.336
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants with baseline and at least one post-baseline 1,5-AG data.
1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares)
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=190 Participants
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=358 Participants
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
|
2.49 milligram per liter (mg/L)
Standard Error 0.363
|
2.21 milligram per liter (mg/L)
Standard Error 0.280
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants with baseline and at least one post-baseline SMBG data.
SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=170 Participants
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=331 Participants
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Morning Premeal
|
2.2 mg/dL
Standard Error 2.62
|
4.4 mg/dL
Standard Error 2.18
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Morning 1-hour Postmeal
|
-12.9 mg/dL
Standard Error 3.77
|
-18.1 mg/dL
Standard Error 3.13
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Morning 2-hour Postmeal
|
-15.9 mg/dL
Standard Error 3.65
|
-21.3 mg/dL
Standard Error 3.02
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Midday Premeal
|
-9.8 mg/dL
Standard Error 3.09
|
-5.7 mg/dL
Standard Error 2.56
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Midday 1-hour Postmeal
|
-15.2 mg/dL
Standard Error 3.52
|
-13.9 mg/dL
Standard Error 2.92
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Midday 2-hour Postmeal
|
-24.4 mg/dL
Standard Error 3.63
|
-22.5 mg/dL
Standard Error 3.02
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Evening Premeal
|
-25.0 mg/dL
Standard Error 3.34
|
-10.9 mg/dL
Standard Error 2.76
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Evening 1-hour Postmeal
|
-17.6 mg/dL
Standard Error 3.65
|
-15.6 mg/dL
Standard Error 3.06
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Evening 2-hour Postmeal
|
-22.1 mg/dL
Standard Error 3.67
|
-22.3 mg/dL
Standard Error 3.05
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Bedtime
|
-22.3 mg/dL
Standard Error 3.38
|
-20.7 mg/dL
Standard Error 2.82
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants with baseline and at least one post-baseline basal insulin dose data.
LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares)
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=193 Participants
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=369 Participants
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Change From Baseline in Insulin Dose
Daily Basal Insulin Dose
|
0.7 Units (U)
Standard Error 0.34
|
1.4 Units (U)
Standard Error 0.26
|
|
Change From Baseline in Insulin Dose
Daily Prandial Insulin Dose
|
14.7 Units (U)
Standard Error 1.04
|
16.7 Units (U)
Standard Error 0.75
|
|
Change From Baseline in Insulin Dose
Total Daily Insulin Dose
|
15.1 Units (U)
Standard Error 1.13
|
17.8 Units (U)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants with baseline and at least one post-baseline HbA1c \<7% and ≤6.5% data.
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=191 Participants
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=358 Participants
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Percentage of Participants With HbA1c <7% and ≤6.5%
HbA1c < 7%
|
44.50 Percentage of participants
|
46.65 Percentage of participants
|
|
Percentage of Participants With HbA1c <7% and ≤6.5%
HbA1c ≤ 6.5%
|
27.23 Percentage of participants
|
27.93 Percentage of participants
|
Adverse Events
Insulin Lispro (Humalog) Lead-in
Serious events: 17 serious events
Other events: 29 other events
Deaths: 0 deaths
Insulin Lispro (Humalog)
Serious events: 15 serious events
Other events: 14 other events
Deaths: 1 deaths
LY900014
Serious events: 33 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro (Humalog) Lead-in
n=628 participants at risk
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
Insulin Lispro (Humalog)
n=200 participants at risk
Participants received 100 U/mL insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=395 participants at risk
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.16%
1/628 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.48%
3/628 • Number of events 3 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.51%
2/395 • Number of events 2 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.76%
3/395 • Number of events 3 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract diabetic
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Diabetic retinopathy
|
0.16%
1/628 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous haemorrhage
|
0.16%
1/628 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous opacities
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Mass
|
0.16%
1/628 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.16%
1/628 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.32%
2/628 • Number of events 2 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.51%
2/395 • Number of events 2 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.16%
1/628 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.16%
1/628 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.32%
2/628 • Number of events 2 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
1.0%
4/395 • Number of events 4 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.16%
1/628 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.51%
2/395 • Number of events 2 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.16%
1/628 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lacunar infarction
|
0.32%
2/628 • Number of events 2 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 3 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.16%
1/628 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.50%
1/200 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/395 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/628 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/200 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
0.25%
1/395 • Number of events 1 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Insulin Lispro (Humalog) Lead-in
n=628 participants at risk
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
Insulin Lispro (Humalog)
n=200 participants at risk
Participants received 100 U/mL insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=395 participants at risk
Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
4.6%
29/628 • Number of events 31 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
7.0%
14/200 • Number of events 14 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
5.3%
21/395 • Number of events 23 • Up to 30 weeks
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60