Trial Outcomes & Findings for A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes (NCT NCT03952130)
NCT ID: NCT03952130
Last Updated: 2023-02-08
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A. It 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) as variables.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
354 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Insulin Lispro (Humalog)
Participants received 100 units per milliliter (U/mL) insulin lispro 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 SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
176
|
|
Overall Study
Received at Least One Dose of Study Drug
|
178
|
176
|
|
Overall Study
COMPLETED
|
176
|
170
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Insulin Lispro (Humalog)
Participants received 100 units per milliliter (U/mL) insulin lispro 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 SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
Baseline Characteristics
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Insulin Lispro (Humalog)
n=178 Participants
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=176 Participants
Participants received 100 U/mL LY900014 SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
Total
n=354 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.60 years
STANDARD_DEVIATION 13.84 • n=93 Participants
|
40.30 years
STANDARD_DEVIATION 13.42 • n=4 Participants
|
42.00 years
STANDARD_DEVIATION 13.72 • n=27 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=93 Participants
|
82 Participants
n=4 Participants
|
160 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
194 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
141 Participants
n=93 Participants
|
144 Participants
n=4 Participants
|
285 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Argentina
|
21 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Region of Enrollment
China
|
141 Participants
n=93 Participants
|
144 Participants
n=4 Participants
|
285 Participants
n=27 Participants
|
|
Region of Enrollment
Mexico
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Hemoglobin A1c (HbA1c)
|
7.82 Percentage of HbA1c
STANDARD_DEVIATION 0.91 • n=93 Participants
|
7.87 Percentage of HbA1c
STANDARD_DEVIATION 0.95 • n=4 Participants
|
7.85 Percentage of HbA1c
STANDARD_DEVIATION 0.93 • n=27 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. It 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) as variables.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=165 Participants
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=161 Participants
Participants received 100 U/mL LY900014 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)
|
-0.28 Percentage of HbA1c
Standard Error 0.063
|
-0.21 Percentage of HbA1c
Standard Error 0.064
|
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. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=141 Participants
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=147 Participants
Participants received 100 U/mL LY900014 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)
|
102.8 milligrams per deciliter (mg/dL)
Standard Error 4.23
|
85.0 milligrams per deciliter (mg/dL)
Standard Error 4.14
|
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. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=140 Participants
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=147 Participants
Participants received 100 U/mL LY900014 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
|
142.2 mg/dL
Standard Error 5.63
|
116.7 mg/dL
Standard Error 5.49
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: All randomized participants who received at least one dose of study drug and had baseline, at least one post-baseline hypoglycemic data.
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 days.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=177 Participants
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=176 Participants
Participants received 100 U/mL LY900014 SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Rate of Severe Hypoglycemia
|
6.88 Events per 100 participant years
|
5.87 Events per 100 participant years
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: All randomized participants who received at least one dose of study drug and had baseline, at least one post-baseline hypoglycemic data.
Documented symptomatic post meal 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 post meal hypoglycemia per year during a defined period is calculated by the total number of documented symptomatic post meal hypoglycemia events within the period divided by the cumulative days on treatment from all participants within that treatment group \*365.25.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=177 Participants
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=176 Participants
Participants received 100 U/mL LY900014 SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Rate of Documented Symptomatic Post Meal Hypoglycemia
<=30 minutes post meal
|
0.11 Events per participant per year
|
0.09 Events per participant per year
|
|
Rate of Documented Symptomatic Post Meal Hypoglycemia
<=1 hour post meal
|
0.75 Events per participant per year
|
1.20 Events per participant per year
|
|
Rate of Documented Symptomatic Post Meal Hypoglycemia
<=2 hours post meal
|
3.80 Events per participant per year
|
4.52 Events per participant per year
|
|
Rate of Documented Symptomatic Post Meal Hypoglycemia
<=4 hours post meal
|
10.2 Events per participant per year
|
12.4 Events per participant per year
|
|
Rate of Documented Symptomatic Post Meal Hypoglycemia
>1 to <=2 hours post meal
|
3.05 Events per participant per year
|
3.32 Events per participant per year
|
|
Rate of Documented Symptomatic Post Meal Hypoglycemia
>2 to <=4 hours post meal
|
6.40 Events per participant per year
|
7.87 Events per participant per year
|
|
Rate of Documented Symptomatic Post Meal Hypoglycemia
>4 hours post meal
|
14.2 Events per participant per year
|
10.5 Events per participant per year
|
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. It accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=164 Participants
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=162 Participants
Participants received 100 U/mL LY900014 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)
|
0.39 milligrams per liter (mg/L)
Standard Error 0.202
|
0.10 milligrams per liter (mg/L)
Standard Error 0.203
|
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 morning (premeal-fasting, 1-hour post meal, 2-hour post meal), midday (premeal, 1-hour post meal, 2-hour post meal), evening (premeal, 1-hour post meal, 2-hour post meal) and bedtime. LS Mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=149 Participants
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=149 Participants
Participants received 100 U/mL LY900014 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-fasting
|
5.5 milligrams per deciliter (mg/dL)
Standard Error 2.90
|
-10.2 milligrams per deciliter (mg/dL)
Standard Error 2.90
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Morning 1-hour post meal
|
-6.4 milligrams per deciliter (mg/dL)
Standard Error 3.53
|
-20.4 milligrams per deciliter (mg/dL)
Standard Error 3.51
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Morning 2-hour postmeal
|
-9.5 milligrams per deciliter (mg/dL)
Standard Error 3.63
|
-24.4 milligrams per deciliter (mg/dL)
Standard Error 3.62
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Midday premeal
|
-6.7 milligrams per deciliter (mg/dL)
Standard Error 3.25
|
-9.0 milligrams per deciliter (mg/dL)
Standard Error 3.26
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Midday 1-hour post meal
|
-4.7 milligrams per deciliter (mg/dL)
Standard Error 3.34
|
-13.8 milligrams per deciliter (mg/dL)
Standard Error 3.33
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Midday 2-hour post meal
|
-10.8 milligrams per deciliter (mg/dL)
Standard Error 3.31
|
-14.1 milligrams per deciliter (mg/dL)
Standard Error 3.33
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Evening premeal
|
-12.2 milligrams per deciliter (mg/dL)
Standard Error 4.00
|
-1.6 milligrams per deciliter (mg/dL)
Standard Error 4.01
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Evening 1-hour post meal
|
-2.4 milligrams per deciliter (mg/dL)
Standard Error 3.54
|
-8.0 milligrams per deciliter (mg/dL)
Standard Error 3.52
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Evening 2-hour post meal
|
-7.0 milligrams per deciliter (mg/dL)
Standard Error 3.50
|
-14.8 milligrams per deciliter (mg/dL)
Standard Error 3.50
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Bedtime
|
-7.9 milligrams per deciliter (mg/dL)
Standard Error 3.84
|
-12.4 milligrams per deciliter (mg/dL)
Standard Error 3.82
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants with baseline and at least one post-baseline insulin dose data.
LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=168 Participants
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=163 Participants
Participants received 100 U/mL LY900014 SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Change From Baseline in Daily Insulin Dose
Basal Insulin Dose
|
0.0 Units per day
Standard Error 0.24
|
0.0 Units per day
Standard Error 0.24
|
|
Change From Baseline in Daily Insulin Dose
Bolus Insulin Dose
|
6.0 Units per day
Standard Error 0.69
|
6.6 Units per day
Standard Error 0.70
|
|
Change From Baseline in Daily Insulin Dose
Total Insulin Dose
|
6.0 Units per day
Standard Error 0.75
|
6.6 Units per day
Standard Error 0.76
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants with baseline and at least one post-baseline HbA1c data.
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=165 Participants
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=161 Participants
Participants received 100 U/mL LY900014 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%
|
28.48 Percentage of participants
|
26.71 Percentage of participants
|
|
Percentage of Participants With HbA1c <7% and ≤6.5%
HbA1c ≤ 6.5%
|
15.15 Percentage of participants
|
9.94 Percentage of participants
|
Adverse Events
Insulin Lispro (Humalog)
Serious events: 12 serious events
Other events: 29 other events
Deaths: 0 deaths
LY900014
Serious events: 13 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro (Humalog)
n=178 participants at risk
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=176 participants at risk
Participants received 100 U/mL LY900014 SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
|---|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/178 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.56%
1/178 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/176 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/178 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.56%
1/178 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/176 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.56%
1/178 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/176 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/178 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/178 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/178 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Traumatic amputation
|
0.00%
0/178 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/178 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/178 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/178 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.56%
1/178 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/176 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.2%
4/178 • Number of events 4 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
3/176 • Number of events 4 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.56%
1/178 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/176 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.56%
1/178 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/176 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.56%
1/178 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
1.3%
1/78 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/82 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/178 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
1.3%
1/78 • Number of events 1 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/82 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Insulin Lispro (Humalog)
n=178 participants at risk
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
|
LY900014
n=176 participants at risk
Participants received 100 U/mL LY900014 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
|
11.8%
21/178 • Number of events 25 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.9%
21/176 • Number of events 25 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight increased
|
5.6%
10/178 • Number of events 10 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
10/176 • Number of events 10 • From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60