Trial Outcomes & Findings for Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide (NCT NCT00560417)
NCT ID: NCT00560417
Last Updated: 2011-01-13
Results Overview
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
339 participants
Primary outcome timeframe
Baseline, Endpoint (LOCF) up to 24 weeks
Results posted on
2011-01-13
Participant Flow
Intention to Treat (ITT) Population consisted of all randomized participants who received at least one dose of study drug and had at least one post-baseline measurement.
Participant milestones
| Measure |
ILPS
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
171
|
168
|
|
Overall Study
Intention to Treat (ITT) Population
|
170
|
167
|
|
Overall Study
COMPLETED
|
154
|
151
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
Reasons for withdrawal
| Measure |
ILPS
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Entry Criteria Not Met
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
6
|
|
Overall Study
Protocol Violation
|
6
|
5
|
|
Overall Study
Sponsor Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
Baseline characteristics by cohort
| Measure |
ILPS
n=171 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=168 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
Total
n=339 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.51 years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
56.24 years
STANDARD_DEVIATION 9.33 • n=7 Participants
|
56.38 years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
West Asian (Indian sub-continent)
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
130 participants
n=5 Participants
|
130 participants
n=7 Participants
|
260 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
165 participants
n=5 Participants
|
165 participants
n=7 Participants
|
330 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Body Mass Index
|
34.92 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 5.21 • n=5 Participants
|
34.78 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 5.17 • n=7 Participants
|
34.85 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 5.18 • n=5 Participants
|
|
Body Weight
|
101.57 Kilograms
STANDARD_DEVIATION 18.67 • n=5 Participants
|
102.33 Kilograms
STANDARD_DEVIATION 19.73 • n=7 Participants
|
101.95 Kilograms
STANDARD_DEVIATION 19.18 • n=5 Participants
|
|
Hemoglobin A1C
|
8.21 percent of glycosylated hemoglobin
STANDARD_DEVIATION 0.79 • n=5 Participants
|
8.22 percent of glycosylated hemoglobin
STANDARD_DEVIATION 0.80 • n=7 Participants
|
8.22 percent of glycosylated hemoglobin
STANDARD_DEVIATION 0.79 • n=5 Participants
|
|
Sulfonylurea Group
Yes
|
108 participants
n=5 Participants
|
110 participants
n=7 Participants
|
218 participants
n=5 Participants
|
|
Sulfonylurea Group
No
|
63 participants
n=5 Participants
|
58 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Duration of Diabetes
|
9.51 years
STANDARD_DEVIATION 5.98 • n=5 Participants
|
10.31 years
STANDARD_DEVIATION 6.63 • n=7 Participants
|
9.91 years
STANDARD_DEVIATION 6.31 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Endpoint (LOCF) up to 24 weeksPopulation: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.
Outcome measures
| Measure |
ILPS
n=170 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
Baseline
|
8.48 percent of glycosylated hemoglobin
Standard Error 0.04
|
8.47 percent of glycosylated hemoglobin
Standard Error 0.04
|
|
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
Endpoint (LOCF) Change
|
-1.21 percent of glycosylated hemoglobin
Standard Error 0.07
|
-1.43 percent of glycosylated hemoglobin
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 24 weeks, Endpoint (LOCF) up to 24 weeksPopulation: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
Outcome measures
| Measure |
ILPS
n=170 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
24 weeks
|
6.94 percent of glycosylated hemoglobin
Standard Error 0.07
|
6.70 percent of glycosylated hemoglobin
Standard Error 0.06
|
|
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Endpoint (LOCF)
|
7.00 percent of glycosylated hemoglobin
Standard Error 0.07
|
6.78 percent of glycosylated hemoglobin
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeksPopulation: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
Outcome measures
| Measure |
ILPS
n=170 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Baseline
|
8.48 percent of glycosylated hemoglobin
Standard Error 0.04
|
8.47 percent of glycosylated hemoglobin
Standard Error 0.04
|
|
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
24 Weeks Change
|
-1.25 percent of glycosylated hemoglobin
Standard Error 0.07
|
-1.49 percent of glycosylated hemoglobin
Standard Error 0.06
|
|
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Endpoint (LOCF) Change
|
-1.21 percent of glycosylated hemoglobin
Standard Error 0.07
|
-1.43 percent of glycosylated hemoglobin
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeksPopulation: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.
Outcome measures
| Measure |
ILPS
n=170 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Week 18: HbA1c <7.0%
|
54.8 percent of participants
|
69.1 percent of participants
|
|
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Week 12: HbA1c <7.0%
|
46.9 percent of participants
|
50.7 percent of participants
|
|
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Week 12: HbA1c <=6.5%
|
24.8 percent of participants
|
28.7 percent of participants
|
|
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Week 18: HbA1c <=6.5%
|
30.8 percent of participants
|
37.6 percent of participants
|
|
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Week 24: HbA1c <7.0%
|
55.4 percent of participants
|
63.4 percent of participants
|
|
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Week 24: HbA1c <=6.5%
|
29.7 percent of participants
|
39.9 percent of participants
|
|
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Endpoint (LOCF): HbA1c <7.0%
|
53.7 percent of participants
|
61.7 percent of participants
|
|
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Endpoint (LOCF): HbA1c <=6.5%
|
28.4 percent of participants
|
38.9 percent of participants
|
SECONDARY outcome
Timeframe: Baseline, Endpoint (LOCF) up to 24 weeksPopulation: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.
SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.
Outcome measures
| Measure |
ILPS
n=170 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Baseline Morning Pre-Meal
|
175.41 milligrams per deciliter (mg/dL)
Standard Deviation 39.54
|
180.86 milligrams per deciliter (mg/dL)
Standard Deviation 38.95
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Baseline Morning Postprandial
|
195.31 milligrams per deciliter (mg/dL)
Standard Deviation 54.65
|
190.84 milligrams per deciliter (mg/dL)
Standard Deviation 54.95
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Baseline Midday Pre-Meal
|
165.18 milligrams per deciliter (mg/dL)
Standard Deviation 43.51
|
166.34 milligrams per deciliter (mg/dL)
Standard Deviation 47.64
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Baseline Midday Postprandial
|
193.22 milligrams per deciliter (mg/dL)
Standard Deviation 46.95
|
200.25 milligrams per deciliter (mg/dL)
Standard Deviation 54.64
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Baseline Evening Pre-Meal
|
173.33 milligrams per deciliter (mg/dL)
Standard Deviation 44.60
|
175.14 milligrams per deciliter (mg/dL)
Standard Deviation 43.35
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Baseline Evening Postprandial
|
189.00 milligrams per deciliter (mg/dL)
Standard Deviation 49.62
|
184.92 milligrams per deciliter (mg/dL)
Standard Deviation 49.42
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Baseline 0300 Hours
|
170.51 milligrams per deciliter (mg/dL)
Standard Deviation 43.44
|
172.00 milligrams per deciliter (mg/dL)
Standard Deviation 39.10
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Baseline Daily Mean 7-Point Blood Glucose
|
180.19 milligrams per deciliter (mg/dL)
Standard Deviation 36.95
|
180.72 milligrams per deciliter (mg/dL)
Standard Deviation 38.17
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Baseline Daily Mean Pre-Meal
|
170.60 milligrams per deciliter (mg/dL)
Standard Deviation 36.06
|
172.66 milligrams per deciliter (mg/dL)
Standard Deviation 38.60
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Baseline Daily Mean Postprandial
|
192.37 milligrams per deciliter (mg/dL)
Standard Deviation 41.48
|
191.27 milligrams per deciliter (mg/dL)
Standard Deviation 46.11
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Endpoint Morning Pre-Meal
|
129.63 milligrams per deciliter (mg/dL)
Standard Deviation 31.58
|
127.01 milligrams per deciliter (mg/dL)
Standard Deviation 29.08
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Endpoint Morning Postprandial
|
152.32 milligrams per deciliter (mg/dL)
Standard Deviation 44.81
|
137.39 milligrams per deciliter (mg/dL)
Standard Deviation 36.65
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Endpoint Midday Pre-Meal
|
132.84 milligrams per deciliter (mg/dL)
Standard Deviation 36.63
|
129.71 milligrams per deciliter (mg/dL)
Standard Deviation 34.34
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Endpoint Midday Postprandial
|
161.77 milligrams per deciliter (mg/dL)
Standard Deviation 42.46
|
155.26 milligrams per deciliter (mg/dL)
Standard Deviation 37.86
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Endpoint Evening Pre-Meal
|
146.03 milligrams per deciliter (mg/dL)
Standard Deviation 37.93
|
135.93 milligrams per deciliter (mg/dL)
Standard Deviation 33.79
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Endpoint Evening Postprandial
|
159.14 milligrams per deciliter (mg/dL)
Standard Deviation 45.35
|
144.25 milligrams per deciliter (mg/dL)
Standard Deviation 34.17
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Endpoint 0300 Hours
|
123.96 milligrams per deciliter (mg/dL)
Standard Deviation 35.45
|
127.53 milligrams per deciliter (mg/dL)
Standard Deviation 30.90
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Endpoint Daily Mean 7-Point Blood Glucose
|
143.06 milligrams per deciliter (mg/dL)
Standard Deviation 30.00
|
136.17 milligrams per deciliter (mg/dL)
Standard Deviation 25.65
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Endpoint Daily Mean Pre-Meal
|
135.51 milligrams per deciliter (mg/dL)
Standard Deviation 30.39
|
129.32 milligrams per deciliter (mg/dL)
Standard Deviation 26.54
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Endpoint Daily Mean Postprandial
|
158.10 milligrams per deciliter (mg/dL)
Standard Deviation 36.81
|
146.12 milligrams per deciliter (mg/dL)
Standard Deviation 30.37
|
SECONDARY outcome
Timeframe: Baseline, Endpoint (LOCF) up to 24 weeksPopulation: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.
Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.
Outcome measures
| Measure |
ILPS
n=170 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Glycemic Variability at Baseline and Endpoint (LOCF)
Baseline
|
41.15 mg/dL
Standard Deviation 13.69
|
39.02 mg/dL
Standard Deviation 13.52
|
|
Glycemic Variability at Baseline and Endpoint (LOCF)
Endpoint
|
36.78 mg/dL
Standard Deviation 16.02
|
30.96 mg/dL
Standard Deviation 13.24
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (LOCF) up to 24 weeksPopulation: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.
Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value \<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)\*100.
Outcome measures
| Measure |
ILPS
n=170 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
All Reported - Endpoint
|
41.8 percentage of participants
|
43.1 percentage of participants
|
|
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
All Reported - Overall
|
70.6 percentage of participants
|
74.9 percentage of participants
|
|
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Non-Nocturnal - Endpoint
|
30.6 percentage of participants
|
40.1 percentage of participants
|
|
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Non-Nocturnal - Overall
|
62.4 percentage of participants
|
70.7 percentage of participants
|
|
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Nocturnal - Endpoint
|
21.8 percentage of participants
|
11.4 percentage of participants
|
|
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Nocturnal - Overall
|
47.6 percentage of participants
|
37.1 percentage of participants
|
|
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Severe - Endpoint
|
0 percentage of participants
|
0 percentage of participants
|
|
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Severe - Overall
|
1.8 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (LOCF) up to 24 weeksPopulation: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.
Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.
Outcome measures
| Measure |
ILPS
n=170 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Nocturnal reported episodes rate - Overall
|
4.88 episodes/participant/365 days
Standard Deviation 8.43
|
3.01 episodes/participant/365 days
Standard Deviation 7.21
|
|
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
All reported episodes rate - Endpoint
|
14.51 episodes/participant/365 days
Standard Deviation 27.75
|
15.29 episodes/participant/365 days
Standard Deviation 29.73
|
|
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
All reported episodes rate - Overall
|
16.27 episodes/participant/365 days
Standard Deviation 23.19
|
18.05 episodes/participant/365 days
Standard Deviation 24.59
|
|
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Non-Nocturnal reported episodes rate - Endpoint
|
10.40 episodes/participant/365 days
Standard Deviation 23.46
|
13.20 episodes/participant/365 days
Standard Deviation 28.01
|
|
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Non-Nocturnal reported episodes rate - Overall
|
11.36 episodes/participant/365 days
Standard Deviation 19.16
|
14.83 episodes/participant/365 days
Standard Deviation 21.00
|
|
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Nocturnal reported episodes rate - Endpoint
|
4.01 episodes/participant/365 days
Standard Deviation 9.73
|
1.73 episodes/participant/365 days
Standard Deviation 5.53
|
SECONDARY outcome
Timeframe: Baseline, Endpoint (LOCF) up to 24 weeksPopulation: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.
Outcome measures
| Measure |
ILPS
n=170 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Actual Body Weight at Baseline and Endpoint (LOCF)
Baseline
|
101.57 kilograms
Standard Deviation 18.67
|
102.62 kilograms
Standard Deviation 19.58
|
|
Actual Body Weight at Baseline and Endpoint (LOCF)
Endpoint
|
101.85 kilograms
Standard Deviation 18.91
|
103.28 kilograms
Standard Deviation 19.42
|
SECONDARY outcome
Timeframe: Baseline, Endpoint (LOCF) up to 24 weeksPopulation: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.
Outcome measures
| Measure |
ILPS
n=170 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Change From Baseline in Body Weight at Endpoint (LOCF)
|
0.27 kilograms
Standard Deviation 3.38
|
0.66 kilograms
Standard Deviation 3.93
|
SECONDARY outcome
Timeframe: Endpoint (LOCF) up to 24 weeksPopulation: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.
Outcome measures
| Measure |
ILPS
n=168 Participants
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=165 Participants
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Total Daily Insulin Dose at Endpoint (LOCF)
|
31.11 Units of Insulin
Standard Deviation 18.87
|
37.93 Units of Insulin
Standard Deviation 18.46
|
Adverse Events
ILPS
Serious events: 9 serious events
Other events: 96 other events
Deaths: 0 deaths
Glargine
Serious events: 5 serious events
Other events: 115 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ILPS
n=170 participants at risk
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 participants at risk
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
2/170 • Number of events 2
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.00%
0/167
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
General disorders
Chest pain
|
0.00%
0/170
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.60%
1/167 • Number of events 1
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/170
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.60%
1/167 • Number of events 2
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Infections and infestations
Appendicitis
|
0.59%
1/170 • Number of events 1
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.00%
0/167
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Infections and infestations
Cystitis bacterial
|
0.59%
1/170 • Number of events 2
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.00%
0/167
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.59%
1/170 • Number of events 2
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.00%
0/167
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/170
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.60%
1/167 • Number of events 3
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.00%
0/170
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.60%
1/167 • Number of events 1
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/170
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.60%
1/167 • Number of events 1
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/170
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.60%
1/167 • Number of events 3
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.59%
1/170 • Number of events 1
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.00%
0/167
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.59%
1/170 • Number of events 1
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.00%
0/167
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.59%
1/170 • Number of events 1
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.00%
0/167
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.59%
1/170 • Number of events 1
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.00%
0/167
Adverse events are reported for the Intention to Treat (ITT) population.
|
Other adverse events
| Measure |
ILPS
n=170 participants at risk
Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
|
Glargine
n=167 participants at risk
Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.5%
6/170 • Number of events 9
Adverse events are reported for the Intention to Treat (ITT) population.
|
2.4%
4/167 • Number of events 5
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
11/170 • Number of events 17
Adverse events are reported for the Intention to Treat (ITT) population.
|
7.2%
12/167 • Number of events 31
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.59%
1/170 • Number of events 1
Adverse events are reported for the Intention to Treat (ITT) population.
|
2.4%
4/167 • Number of events 14
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Gastrointestinal disorders
Nausea
|
7.6%
13/170 • Number of events 37
Adverse events are reported for the Intention to Treat (ITT) population.
|
6.0%
10/167 • Number of events 14
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
6/170 • Number of events 7
Adverse events are reported for the Intention to Treat (ITT) population.
|
4.8%
8/167 • Number of events 11
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
General disorders
Pyrexia
|
0.59%
1/170 • Number of events 1
Adverse events are reported for the Intention to Treat (ITT) population.
|
3.0%
5/167 • Number of events 5
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Infections and infestations
Bronchitis
|
0.59%
1/170 • Number of events 3
Adverse events are reported for the Intention to Treat (ITT) population.
|
3.0%
5/167 • Number of events 9
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Infections and infestations
Gastroenteritis viral
|
1.2%
2/170 • Number of events 2
Adverse events are reported for the Intention to Treat (ITT) population.
|
7.2%
12/167 • Number of events 15
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Infections and infestations
Influenza
|
2.4%
4/170 • Number of events 8
Adverse events are reported for the Intention to Treat (ITT) population.
|
1.8%
3/167 • Number of events 4
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
12/170 • Number of events 18
Adverse events are reported for the Intention to Treat (ITT) population.
|
5.4%
9/167 • Number of events 14
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Infections and infestations
Sinusitis
|
4.1%
7/170 • Number of events 17
Adverse events are reported for the Intention to Treat (ITT) population.
|
5.4%
9/167 • Number of events 26
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
11/170 • Number of events 23
Adverse events are reported for the Intention to Treat (ITT) population.
|
6.0%
10/167 • Number of events 24
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
5/170 • Number of events 9
Adverse events are reported for the Intention to Treat (ITT) population.
|
1.2%
2/167 • Number of events 3
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.4%
4/170 • Number of events 27
Adverse events are reported for the Intention to Treat (ITT) population.
|
1.2%
2/167 • Number of events 10
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
9/170 • Number of events 19
Adverse events are reported for the Intention to Treat (ITT) population.
|
4.2%
7/167 • Number of events 35
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
3/170 • Number of events 8
Adverse events are reported for the Intention to Treat (ITT) population.
|
2.4%
4/167 • Number of events 9
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
2/170 • Number of events 7
Adverse events are reported for the Intention to Treat (ITT) population.
|
2.4%
4/167 • Number of events 28
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/170
Adverse events are reported for the Intention to Treat (ITT) population.
|
2.4%
4/167 • Number of events 5
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
3/170 • Number of events 5
Adverse events are reported for the Intention to Treat (ITT) population.
|
3.0%
5/167 • Number of events 17
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Nervous system disorders
Headache
|
6.5%
11/170 • Number of events 44
Adverse events are reported for the Intention to Treat (ITT) population.
|
9.0%
15/167 • Number of events 42
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Nervous system disorders
Sinus headache
|
2.4%
4/170 • Number of events 4
Adverse events are reported for the Intention to Treat (ITT) population.
|
0.60%
1/167 • Number of events 2
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
5/170 • Number of events 13
Adverse events are reported for the Intention to Treat (ITT) population.
|
3.0%
5/167 • Number of events 13
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.8%
3/170 • Number of events 5
Adverse events are reported for the Intention to Treat (ITT) population.
|
5.4%
9/167 • Number of events 18
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
4/170 • Number of events 9
Adverse events are reported for the Intention to Treat (ITT) population.
|
4.2%
7/167 • Number of events 11
Adverse events are reported for the Intention to Treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.5%
6/170 • Number of events 13
Adverse events are reported for the Intention to Treat (ITT) population.
|
1.2%
2/167 • Number of events 8
Adverse events are reported for the Intention to Treat (ITT) population.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60