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Trial record 89 of 2358 for:    "Diabetes Mellitus, Insulin-Dependent"

A Study in Adults With Type 1 Diabetes (ELEMENT 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01421147
Recruitment Status : Completed
First Posted : August 22, 2011
Results First Posted : October 9, 2014
Last Update Posted : October 9, 2014
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Drug: LY2963016
Drug: Lantus
Drug: Insulin Lispro
Enrollment 536
Recruitment Details  
Pre-assignment Details This study included a 24-week treatment period followed by a 28-week extension period.
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks. Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Period Title: Treatment Period
Started 269 267
Received at Least 1 Dose of Study Drug 268 267
Completed 253 256
Not Completed 16 11
Reason Not Completed
Adverse Event             2             3
Lost to Follow-up             2             1
Physician Decision             2             2
Withdrawal by Subject             10             5
Period Title: Extension Period
Started 253 256
Completed 245 245
Not Completed 8 11
Reason Not Completed
Adverse Event             0             2
Death             0             1
Lost to Follow-up             2             5
Physician Decision             1             0
Withdrawal by Subject             5             3
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro Total
Hide Arm/Group Description LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks. Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 268 267 535
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 268 participants 267 participants 535 participants
40.96  (13.65) 41.37  (13.25) 41.16  (13.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 268 participants 267 participants 535 participants
Female
113
  42.2%
112
  41.9%
225
  42.1%
Male
155
  57.8%
155
  58.1%
310
  57.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 268 participants 267 participants 535 participants
Hispanic or Latino
11
   4.1%
10
   3.7%
21
   3.9%
Not Hispanic or Latino
177
  66.0%
170
  63.7%
347
  64.9%
Unknown or Not Reported
80
  29.9%
87
  32.6%
167
  31.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 268 participants 267 participants 535 participants
American Indian or Alaska Native
11
   4.1%
12
   4.5%
23
   4.3%
Asian
49
  18.3%
51
  19.1%
100
  18.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
   3.4%
2
   0.7%
11
   2.1%
White
197
  73.5%
201
  75.3%
398
  74.4%
More than one race
1
   0.4%
1
   0.4%
2
   0.4%
Unknown or Not Reported
1
   0.4%
0
   0.0%
1
   0.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 268 participants 267 participants 535 participants
United States 99 96 195
Hungary 14 16 30
Mexico 17 19 36
Greece 15 13 28
Belgium 12 11 23
Poland 18 17 35
Romania 18 16 34
Germany 26 28 54
Japan 49 51 100
Baseline Hemoglobin A1c (HbA1c)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated hemoglobin
Number Analyzed 268 participants 267 participants 535 participants
7.75  (1.13) 7.79  (1.03) 7.77  (1.08)
[1]
Measure Description: HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period.
Time of Basal Insulin Injection   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 268 participants 267 participants 535 participants
Daytime 51 48 99
Evening/Bedtime 217 219 436
[1]
Measure Description: Number of participants who administered a basal insulin injection during the Daytime and Evening/Bedtime.
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 268 participants 267 participants 535 participants
75.80  (16.76) 74.77  (15.36) 75.29  (16.07)
1.Primary Outcome
Title Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)
Hide Description HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time Frame Baseline, Endpoint (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used.
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 267 267
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated hemoglobin
-0.352  (0.053) -0.460  (0.054)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.108
Confidence Interval (2-Sided) 95%
-0.002 to 0.219
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Insulin Antibody Levels
Hide Description Blood samples are collected from participants and percentage of insulin antibody binding was measured to determine the insulin antibody levels. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time Frame Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and were insulin antibody positive at baseline and had at least 1 post-baseline insulin antibody positive measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 and up to 52 weeks).
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 40 47
Least Squares Mean (Standard Error)
Unit of Measure: percentage of insulin antibody binding
Change at 6 weeks (n=31, 38) 0.30  (0.33) -0.12  (0.33)
Change at 12 weeks (n=27, 36) 0.02  (0.39) -0.38  (0.39)
Change at Endpoint, up to 24 weeks (n=37, 47) 0.47  (0.45) 0.09  (0.44)
Change at Endpoint, up to 52 weeks (n=40, 47) 0.87  (0.58) 0.06  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments P-value is for change at 6 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
-0.23 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.320
Comments P-value is for change at 12 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
-0.40 to 1.21
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.373
Comments P-value is for change at Endpoint, up to 24 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-0.46 to 1.21
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments P-value is for change at Endpoint, up to 52 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
-0.25 to 1.86
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Hemoglobin A1c (HbA1c)
Hide Description HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time Frame Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline HbA1c measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 267 267
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated hemoglobin
Change at 6 weeks (n=265, 265) -0.369  (0.038) -0.362  (0.039)
Change at 12 weeks (n=261, 262) -0.359  (0.049) -0.472  (0.049)
Change at 24 weeks (n=256, 258) -0.383  (0.053) -0.481  (0.053)
Change at 36 weeks (n=253, 254) -0.349  (0.056) -0.408  (0.056)
Change at 52 weeks (n=248, 246) -0.302  (0.059) -0.306  (0.060)
Change at Endpoint, up to 52 weeks (n=267, 267) -0.256  (0.057) -0.276  (0.058)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.860
Comments P-value is for change at 6 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.007
Confidence Interval (2-Sided) 95%
-0.087 to 0.072
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments P-value is for change at 12 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.113
Confidence Interval (2-Sided) 95%
0.011 to 0.215
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments P-value is for change at 24 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.098
Confidence Interval (2-Sided) 95%
-0.012 to 0.208
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.314
Comments P-value is for change at 36 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.060
Confidence Interval (2-Sided) 95%
-0.057 to 0.177
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.948
Comments P-value is for change at 52 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.004
Confidence Interval (2-Sided) 95%
-0.119 to 0.127
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.737
Comments P-value is for change at Endpoint, up to 52 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.020
Confidence Interval (2-Sided) 95%
-0.099 to 0.140
Estimation Comments [Not Specified]
4.Secondary Outcome
Title 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Hide Description 7-point SMBG measurements are completed at the following timepoints: Morning (AM) Pre-Meal, AM Post-Prandial (PP), Midday (MD) Pre-Meal, MD PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Values for the 7-point SMBG profiles were averaged over the three 7-point SMBG profiles during 2-week period prior to each visit. If only 1 of the 3 days of data was collected, then the value of the 1 day was used. If only 2 of the 3 days of data were collected, then the average of the 2 days was used. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time Frame Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline SMBG measurement. Last observation carried forward (LOCF) principle was used.
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 266 265
Least Squares Mean (Standard Error)
Unit of Measure: millimoles per liter (mmol/L)
Baseline-AM Pre-Meal (n=266, 264) 8.37  (0.18) 8.19  (0.18)
Baseline-AM 2 hrs PP (n=263, 262) 8.93  (0.19) 9.41  (0.19)
Baseline-MD Pre-Meal (n=266, 265) 7.86  (0.16) 8.14  (0.16)
Baseline-MD 2 hrs PP (n=264, 264) 9.12  (0.18) 8.81  (0.18)
Baseline-EV Pre-Meal (n=264, 264) 8.87  (0.19) 8.82  (0.19)
Baseline-Bed Time (n=266, 264) 9.26  (0.20) 9.37  (0.20)
Baseline-0300 hrs (n=262, 257) 8.27  (0.18) 8.37  (0.18)
Endpoint, up to 24 wk-AM Pre-Meal (n=266, 264) 7.98  (0.20) 7.81  (0.20)
Endpoint, up to 24 wk-AM 2 hrs PP (n=263, 262) 8.75  (0.20) 8.50  (0.21)
Endpoint, up to 24 wk-MD Pre-Meal (n=266, 265) 7.81  (0.19) 7.84  (0.20)
Endpoint, up to 24 wk-MD 2 hrs PP (n=264, 264) 8.50  (0.21) 8.41  (0.21)
Endpoint, up to 24 wk-EV Pre-Meal (n=264, 264) 8.82  (0.21) 8.61  (0.22)
Endpoint, up to 24 wk-Bed Time (n=266, 264) 8.61  (0.22) 9.11  (0.22)
Endpoint, up to 24 wk-0300 hrs (n=262, 257) 7.93  (0.20) 8.38  (0.20)
Endpoint, up to 52 wk- AM Pre-Meal (n=266, 264) 8.03  (0.20) 8.29  (0.21)
Endpoint, up to 52 wk-AM 2 hrs PP (n=263, 262) 8.55  (0.21) 8.88  (0.21)
Endpoint, up to 52 wk-MD Pre-Meal (n=266, 265) 7.96  (0.19) 7.99  (0.19)
Endpoint, up to 52 wk-MD 2 hrs PP (n=264, 264) 8.61  (0.21) 8.74  (0.21)
Endpoint, up to 52 wk-EV Pre-Meal (n=264, 264) 8.37  (0.21) 8.38  (0.21)
Endpoint, up to 52 wk-Bed Time (n=266, 264) 8.57  (0.21) 9.06  (0.21)
Endpoint, up to 52 wk-0300 hrs (n=262, 257) 8.22  (0.21) 8.43  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.489
Comments P-value is for Baseline-AM Pre-Meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.33 to 0.69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments P-value is for Baseline-AM 2 hrs PP.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-1.00 to 0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.209
Comments P-value is for Baseline-MD Pre-Meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.71 to 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.232
Comments P-value is for Baseline-MD 2 hrs PP.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
-0.20 to 0.82
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.856
Comments P-value is for Baseline-EV Pre-Meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.49 to 0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.693
Comments P-value is for Baseline-Bed Time.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.66 to 0.44
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.700
Comments P-value is for Baseline-0300 hrs.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.61 to 0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.399
Comments P-value is for Endpoint, up to 24 wk-AM Pre-Meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.23 to 0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.248
Comments P-value is for Endpoint, up to 24 wk-AM 2 hrs PP.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.18 to 0.68
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.883
Comments P-value is for Endpoint, up to 24 wk-MD Pre-Meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.44 to 0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.687
Comments P-value is for Endpoint, up to 24 wk-MD 2 hrs PP.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.34 to 0.52
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.364
Comments P-value is for Endpoint, up to 24 wk-EV Pre-Meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.24 to 0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments P-value is for Endpoint, up to 24 wk- Bed Time.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.95 to -0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments P-value is for Endpoint, up to 24 wk-0300 hrs.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.86 to -0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.230
Comments P-value is for Endpoint, up to 52 wk-AM Pre-Meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-0.68 to 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments P-value is for Endpoint, up to 52 wk-AM 2 hrs PP.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.76 to 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.866
Comments P-value is for Endpoint, up to 52 wk-MD Pre-Meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.43 to 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.545
Comments P-value is for Endpoint, up to 52 wk-MD 2 hrs PP.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.56 to 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.955
Comments P-value is for Endpoint, up to 52 wk-EV Pre-Meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.44 to 0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments P-value is for Endpoint, up to 52 wk-Bed Time.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.92 to -0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.355
Comments P-vale is for Endpoint, up to 52 wk-0300 hrs.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.65 to 0.23
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Glycemic Variability of Fasting Blood Glucose
Hide Description Glycemic variability is the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning premeal blood glucose value from the 7-point self-monitoring blood glucose (SMBG) profiles. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time Frame Baseline and Endpoints (up to 24 weeks and up 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline fasting blood glucose measurement. Last observation carried forward (LOCF) principle was used.
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 264 259
Least Squares Mean (Standard Error)
Unit of Measure: millimoles per liter (mmol/L)
Baseline 2.51  (0.12) 2.68  (0.12)
Endpoint, up to 24 weeks 2.25  (0.14) 2.29  (0.14)
Endpoint, up to 52 weeks 2.08  (0.13) 2.34  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.320
Comments P-value is for Baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.52 to 0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.781
Comments P-value is for Endpoint, up to 24 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.33 to 0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments P-value is for Endpoint, up to 52 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-0.53 to 0.01
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time Frame Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline body weight measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 268 267
Least Squares Mean (Standard Error)
Unit of Measure: kilogram (kg)
Change at 6 weeks (n=265, 265) 0.45  (0.09) 0.42  (0.09)
Change at 12 weeks (n=261, 261) 0.59  (0.13) 0.48  (0.13)
Change at 18 weeks (n=258, 260) 0.72  (0.15) 0.55  (0.15)
Change at Endpoint, up to 24 weeks (n=268, 267) 0.66  (0.17) 0.42  (0.17)
Change at Endpoint, up to 52 weeks (n=268, 267) 0.93  (0.21) 0.59  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.823
Comments P-value is for change at 6 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.23 to 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.541
Comments P-value is for change at 12 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.25 to 0.47
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.435
Comments P-value is for change at 18 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.25 to 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.320
Comments P-value is for change at Endpoint, up to 24 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.23 to 0.71
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.253
Comments P-value is for change at Endpoint, up to 52 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-0.25 to 0.93
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Adult Low Blood Sugar Survey (ALBSS)
Hide Description ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score (TS) range is 0 to 60 and Worry TS range is 0 to 72. Higher scores on "Behavior" items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on "Worry" items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time Frame Baseline and 24 weeks and Endpoint (up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ALBSS measurement. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 265 263
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline-Behavior TS (n=265, 263) 13.63  (0.54) 12.99  (0.54)
24 weeks-Behavior TS (n=255, 257) 12.73  (0.66) 12.53  (0.66)
Endpoint, up to 52 weeks-Behavior TS (n=265, 263) 13.19  (0.62) 13.03  (0.62)
Baseline-Worry TS (n=265, 263) 16.01  (0.83) 14.81  (0.83)
24 weeks-Worry TS (n=255, 258) 15.39  (1.08) 14.27  (1.08)
Endpoint, up to 52 weeks-Worry TS (n=265, 263) 15.18  (1.03) 14.93  (1.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments P-value is for Baseline-Behavior TS.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
-0.86 to 2.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.778
Comments P-value is for 24 weeks-Behavior TS
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-1.16 to 1.55
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.804
Comments P-value is for Endpoint, up to 52 weeks-Behavior TS.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-1.12 to 1.45
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.304
Comments P-value is for Baseline-Worry TS.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.21
Confidence Interval 95%
-1.10 to 3.51
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.323
Comments P-value is for 24 weeks-Worry TS.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
-1.10 to 3.34
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.824
Comments P-value is for Endpoint, up to 52 weeks-Worry TS.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.25
Confidence Interval 95%
-1.92 to 2.41
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Insulin Treatment Satisfaction Questionnaire (ITSQ)
Hide Description ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. Items divided into 5 domains: Inconvenience of Regimen [(IR) 5 items: scores range 5-35], Lifestyle Flexibility [(LF) 3 items: scores range 3-21], Glycemic Control [(GC) 3 items: scores range 3-21], Hypoglycemic Control [(HC) 5 items: scores range 5-35], Insulin Delivery Device [(IDD) 6 items: scores range 6-42]. ITSQ Total Overall Scores range from 22-154. Data presented are the transformed score on a scale of 0-100, where transformed score=100×[(7-raw score)/6]. Higher scores indicate better treatment satisfaction. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time Frame Baseline and 24 weeks and Endpoint (up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ITSQ measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 264 262
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
IR-Baseline (n=264, 263) 74.62  (1.31) 75.39  (1.32)
IR-24 weeks (n=254, 258) 79.32  (1.62) 78.76  (1.62)
IR-Endpoint, up to 52 weeks (n=264, 263) 79.50  (1.60) 80.44  (1.62)
LF-Baseline (n=264, 263) 63.19  (1.47) 62.38  (1.47)
LF-24 weeks (n=254, 258) 64.18  (1.90) 63.34  (1.90)
LF-Endpoint, up to 52 weeks (n=264, 263) 63.25  (1.86) 64.16  (1.88)
GC-Baseline (n=264, 263) 64.44  (1.34) 64.34  (1.34)
GC-24 weeks (n=254, 258) 72.99  (1.62) 71.73  (1.62)
GC-Endpoint, up to 52 weeks (n=264, 263) 70.15  (1.67) 69.24  (1.69)
HC-Baseline (n=264, 263) 70.20  (1.15) 70.81  (1.15)
HC-24 weeks (n=254, 258) 70.40  (1.48) 71.42  (1.48)
HC-Endpoint, up to 52 weeks (n=264, 263) 70.46  (1.47) 71.72  (1.49)
IDD-Baseline (n=262, 262) 75.22  (1.20) 76.75  (1.20)
IDD-24 weeks (n=252, 258) 79.77  (1.42) 79.36  (1.42)
IDD-Endpoint, up to 52 weeks (n=262, 262) 79.46  (1.37) 79.75  (1.39)
ITSQ Total-Baseline (n=264, 262) 70.80  (0.99) 71.39  (1.00)
ITSQ Total-24 weeks (n=253, 258) 74.46  (1.23) 74.23  (1.24)
ITSQ Total-Endpoint, up to 52 weeks (n=264, 262) 73.94  (1.25) 74.48  (1.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.681
Comments P-value is for IR-Baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.77
Confidence Interval (2-Sided) 95%
-4.42 to 2.89
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.744
Comments P-value is for IR-24 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
-2.79 to 3.90
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.582
Comments P-value is for IR-Endpoint, up to 52 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-4.29 to 2.41
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.694
Comments P-value is for LF-Baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
-3.26 to 4.89
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.673
Comments P-value is for LF-24 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
-3.08 to 4.77
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.645
Comments P-value is for LF-Endpoint, up to 52 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-4.79 to 2.97
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.961
Comments P-value is for GC-Baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-3.62 to 3.81
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.463
Comments P-value is for GC-24 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
-2.10 to 4.61
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.609
Comments P-value is for GC-Endpoint, up to 52 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
-2.59 to 4.41
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments P-value is for HC-Baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-3.81 to 2.59
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.510
Comments P-value is for HC-24 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.03
Confidence Interval (2-Sided) 95%
-4.09 to 2.03
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.422
Comments P-value is for HC-Endpoint, up to 52 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.26
Confidence Interval (2-Sided) 95%
-4.34 to 1.82
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.367
Comments P-value is for IDD-Baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.53
Confidence Interval (2-Sided) 95%
-4.85 to 1.80
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.786
Comments P-value is for IDD-24 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
-2.54 to 3.35
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.845
Comments P-value is for IDD-Endpoint, up to 52 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-3.16 to 2.59
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.676
Comments P-value is for ITSQ Total-Baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-3.36 to 2.18
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.862
Comments P-value is for ITSQ Total-24 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-2.33 to 2.78
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
Comments P-value is for ITSQ Total-Endpoint, up to 52 weeks.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-3.15 to 2.07
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)])
Hide Description Total daily insulin dose was adjusted for body weight [units of insulin/kilogram/day (U/kg/day)]. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time Frame Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 daily insulin dose per body weight measurements. Last observation carried forward (LOCF) principle was used.
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 268 266
Least Squares Mean (Standard Error)
Unit of Measure: U/kg/day
Endpoint, up to 24 wk-Basal Insulin (n=268, 266) 0.371  (0.011) 0.358  (0.011)
Endpoint, up to 24 wk-Bolus Insulin (n=264, 266) 0.352  (0.015) 0.346  (0.016)
Endpoint, up to 24 wk-Total Insulin (n=264, 266) 0.723  (0.021) 0.704  (0.021)
Endpoint, up to 52 wk-Basal Insulin (n=268, 266) 0.379  (0.012) 0.361  (0.012)
Endpoint, up to 52 wk-Bolus Insulin (n=264, 266) 0.369  (0.016) 0.370  (0.016)
Endpoint, up to 52 wk-Total Insulin (n=264, 266) 0.748  (0.022) 0.731  (0.022)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.235
Comments P-value is for Endpoint, up to 24 wk-Basal Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.014
Confidence Interval (2-Sided) 95%
-0.009 to 0.036
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.726
Comments P-value is for Endpoint, up to 24 wk-Bolus Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.006
Confidence Interval (2-Sided) 95%
-0.026 to 0.038
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.377
Comments P-value is for Endpoint, up to 24 wk-Total Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.019
Confidence Interval (2-Sided) 95%
-0.023 to 0.062
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments P-value is for Endpoint, up to 52 wk-Basal Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.018
Confidence Interval (2-Sided) 95%
-0.007 to 0.042
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.957
Comments P-value is for Endpoint, up to 52 wk-Bolus Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.001
Confidence Interval (2-Sided) 95%
-0.034 to 0.032
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.450
Comments P-value is for Endpoint, up to 52 wk-Total Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.017
Confidence Interval (2-Sided) 95%
-0.028 to 0.062
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)])
Hide Description Units of insulin taken daily were presented. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time Frame Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 insulin daily dose measurements. Last observation carried forward (LOCF) principle was used.
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 268 266
Least Squares Mean (Standard Error)
Unit of Measure: units of insulin per day (U/day)
Endpoint, up to 24 wk-Basal Insulin (n=268, 266) 27.773  (0.970) 26.049  (0.987)
Endpoint, up to 24 wk-Bolus Insulin (n=264, 266) 26.337  (1.347) 25.069  (1.362)
Endpoint, up to 24 wk-Total Insulin (n=264, 266) 54.118  (1.948) 51.154  (1.970)
Endpoint, up to 52 wk-Basal Insulin (n=268, 266) 28.463  (1.073) 26.404  (1.091)
Endpoint, up to 52 wk-Bolus Insulin (n=264, 266) 27.800  (1.329) 27.098  (1.344)
Endpoint, up to 52 wk-Total Insulin (n=264, 266) 56.255  (2.008) 53.454  (2.031)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments P-value is for Endpoint, up to 24 wk-Basal Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.724
Confidence Interval (2-Sided) 95%
-0.308 to 3.755
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.374
Comments P-value is for Endpoint, up to 24 wk-Bolus Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.267
Confidence Interval (2-Sided) 95%
-1.531 to 4.065
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments P-value is for Endpoint, up to 24 wk-Total Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.964
Confidence Interval (2-Sided) 95%
-1.081 to 7.010
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments P-value is for Endpoint, up to 52 wk-Basal Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.059
Confidence Interval (2-Sided) 95%
-0.187 to 4.305
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.617
Comments P-value is for Endpoint, up to 52 wk-Bolus Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.702
Confidence Interval (2-Sided) 95%
-2.058 to 3.462
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.188
Comments P-value is for Endpoint, up to 52 wk-Total Insulin.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.800
Confidence Interval (2-Sided) 95%
-1.370 to 6.971
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5%
Hide Description HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. The percentage of participants with Hemoglobin A1c (HbA1c) <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.
Time Frame Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 267 267
Measure Type: Number
Unit of Measure: percentage of participants
HbA1c- at Baseline <7.0 % (n=267, 267) 28.8 19.5
HbA1c- at Baseline ≤6.5% (n=267, 267) 13.9 12.0
HbA1c- at 6 weeks <7.0% (n=265, 265) 37.0 26.4
HbA1c- at 6 weeks ≤6.5% (n=265, 265) 21.1 14.3
HbA1c- at 12 weeks <7.0% (n=261, 262) 33.3 29.8
HbA1c- at 12 weeks ≤6.5% (n=261, 262) 19.9 15.3
HbA1c- at 24 weeks <7.0% (n=256, 258) 34.0 33.3
HbA1c- at 24 weeks ≤6.5% (n=256, 258) 19.9 19.0
HbA1c- at 36 weeks <7.0% (n=253, 254) 32.0 28.3
HbA1c- at 36 weeks ≤6.5% (n=253, 254) 15.4 18.5
HbA1c- at 52 weeks <7.0% (n=248, 246) 29.8 27.2
HbA1c- at 52 weeks ≤6.5% (n=248, 246) 15.3 14.6
HbA1c- Endpoint, up to 24 weeks <7.0% (n=267, 267) 34.5 32.2
HbA1c- Endpoint, up to 24 weeks ≤6.5% (n=267, 267) 20.2 18.4
HbA1c- Endpoint, up to 52 weeks <7.0% (n=267, 267) 30.3 25.1
HbA1c- Endpoint, up to 52 weeks ≤6.5% (n=267, 267) 15.7 13.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments P-value is for HbA1c- at Baseline <7.0 %.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.606
Comments P-value is for HbA1c- at Baseline ≤6.5%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P-value is for HbA1c- at 6 weeks <7.0%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments P-value is for HbA1c- at 6 weeks ≤6.5%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.398
Comments P-value is for HbA1c- at 12 weeks <7.0%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.170
Comments P-value is for HbA1c- at 12 weeks ≤6.5%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.926
Comments P-value is for HbA1c- at 24 weeks <7.0%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.824
Comments P-value is for HbA1c- at 24 weeks ≤6.5%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.385
Comments P-value is for HbA1c- at 36 weeks <7.0%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.408
Comments P-value is for HbA1c- at 36 weeks ≤6.5%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.551
Comments P-value is for HbA1c- at 52 weeks <7.0%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.900
Comments P-value is for HbA1c- at 52 weeks ≤6.5%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.646
Comments P-value is for HbA1c- Endpoint, up to 24 weeks <7.0%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments P-value is for HbA1c- Endpoint, up to 24 weeks ≤6.5%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.209
Comments P-value is for HbA1c- Endpoint, up to 52 weeks <7.0%.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.540
Comments P-value is for HbA1c- Endpoint, up to 52 weeks ≤6.5%.
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Incidence of Hypoglycemic Events
Hide Description Incidence of hypoglycemic events is defined as the number of hypoglycemic events. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005]. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
Time Frame Baseline through 24 weeks (wk) and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 268 267
Measure Type: Number
Unit of Measure: events
Total Events with BG ≤70 mg/dL,if available-24 wk 10411 10976
Total Events with BG ≤70 mg/dL,if available-52-wk 19541 20852
Severe Events-24 wk 6 10
Severe Events-52 wk 13 16
Nocturnal Events with BG ≤70 mg/dL-24 wk 2217 2249
Nocturnal Events with BG ≤70 mg/dL-52 wk 4105 4485
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.703
Comments P-value is for Total Events with BG ≤70 mg/dL,if available-24 wk.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments P-value is for Total Events with BG ≤70 mg/dL,if available-52-wk.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.174
Comments P-value is for Severe Events-24 wk.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.828
Comments P-value is for Severe Events-52 wk.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.606
Comments P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.
Method Fisher Exact
Comments [Not Specified]
13.Secondary Outcome
Title Rate Per 30 Days of Hypoglycemic Events
Hide Description The rate of hypoglycemic events per 30 days is defined as the total number of events between visits divided by the actual number of days between visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
Time Frame Baseline through 24 weeks (wk) and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description:
LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Overall Number of Participants Analyzed 268 267
Mean (Standard Deviation)
Unit of Measure: hypoglycemic events per 30 days
Total Events with BG ≤70 mg/dL, if available-24 wk 7.10  (6.35) 7.32  (6.58)
Severe Events-24 wk 0.00  (0.04) 0.01  (0.04)
Nocturnal Events with BG ≤70 mg/dL-24 wk 1.50  (1.93) 1.51  (1.77)
Total Events with BG ≤70 mg/dL, if available-52 wk 6.33  (5.64) 6.56  (6.12)
Severe Events-52 wk 0.01  (0.04) 0.01  (0.04)
Nocturnal Events with BG ≤70 mg/dL-52 wk 1.32  (1.66) 1.42  (1.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.717
Comments P-value is for Total Events with BG ≤70 mg/dL, if available-24 wk.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.163
Comments P-value is for Severe Events-24 wk.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.669
Comments P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.738
Comments P-value is for Total Events with BG ≤70 mg/dL, if available-52 wk.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments P-value is for Severe Events-52 wk.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2963016 + Insulin Lispro, Lantus + Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.250
Comments P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Hide Arm/Group Description LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks. Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
All-Cause Mortality
LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/268 (7.46%)      24/267 (8.99%)    
Blood and lymphatic system disorders     
Pancytopenia  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Cardiac disorders     
Hypertrophic cardiomyopathy  1 [1]  0/268 (0.00%)  0 1/267 (0.37%)  1
General disorders     
Chest pain  1  1/268 (0.37%)  1 0/267 (0.00%)  0
Infections and infestations     
Acute tonsillitis  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Cellulitis  1  1/268 (0.37%)  1 0/267 (0.00%)  0
Gangrene  1  1/268 (0.37%)  1 0/267 (0.00%)  0
Gastroenteritis  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Lung infection  1  1/268 (0.37%)  1 0/267 (0.00%)  0
Pneumonia bacterial  1  1/268 (0.37%)  1 0/267 (0.00%)  0
Injury, poisoning and procedural complications     
Alcohol poisoning  1  1/268 (0.37%)  1 0/267 (0.00%)  0
Maternal exposure during pregnancy  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Toxicity to various agents  1  1/268 (0.37%)  1 0/267 (0.00%)  0
Upper limb fracture  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Metabolism and nutrition disorders     
Hypoglycaemia  1  13/268 (4.85%)  16 12/267 (4.49%)  17
Ketoacidosis  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Musculoskeletal and connective tissue disorders     
Exostosis of jaw  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gliomatosis cerebri  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Nervous system disorders     
Convulsion  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Syncope  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Trigeminal neuralgia  1  1/268 (0.37%)  1 0/267 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Psychiatric disorders     
Psychotic disorder  1  1/268 (0.37%)  1 0/267 (0.00%)  0
Suicidal ideation  1  1/268 (0.37%)  1 0/267 (0.00%)  0
Suicide attempt  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Respiratory, thoracic and mediastinal disorders     
Nasal septum deviation  1  0/268 (0.00%)  0 1/267 (0.37%)  1
Vascular disorders     
Hypertension  1  1/268 (0.37%)  1 0/267 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
[1]
Event resulted in death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
LY2963016 + Insulin Lispro Lantus + Insulin Lispro
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   161/268 (60.07%)      158/267 (59.18%)    
Gastrointestinal disorders     
Abdominal pain upper  1  3/268 (1.12%)  3 5/267 (1.87%)  6
Diarrhoea  1  12/268 (4.48%)  13 10/267 (3.75%)  16
Gastritis  1  3/268 (1.12%)  3 4/267 (1.50%)  4
Gastrooesophageal reflux disease  1  4/268 (1.49%)  4 3/267 (1.12%)  3
Nausea  1  1/268 (0.37%)  1 3/267 (1.12%)  4
Toothache  1  4/268 (1.49%)  5 1/267 (0.37%)  3
Vomiting  1  6/268 (2.24%)  6 2/267 (0.75%)  2
General disorders     
Fatigue  1  4/268 (1.49%)  4 3/267 (1.12%)  4
Influenza like illness  1  3/268 (1.12%)  4 5/267 (1.87%)  6
Injection site reaction  1  3/268 (1.12%)  17 2/267 (0.75%)  3
Pyrexia  1  4/268 (1.49%)  4 0/267 (0.00%)  0
Immune system disorders     
Seasonal allergy  1  3/268 (1.12%)  3 2/267 (0.75%)  2
Infections and infestations     
Bronchitis  1  4/268 (1.49%)  4 8/267 (3.00%)  9
Cystitis  1  0/268 (0.00%)  0 3/267 (1.12%)  3
Gastroenteritis  1  8/268 (2.99%)  8 7/267 (2.62%)  7
Gastroenteritis viral  1  5/268 (1.87%)  6 3/267 (1.12%)  3
Influenza  1  5/268 (1.87%)  7 9/267 (3.37%)  9
Nasopharyngitis  1  43/268 (16.04%)  68 45/267 (16.85%)  58
Pharyngitis  1  3/268 (1.12%)  3 4/267 (1.50%)  4
Sinusitis  1  7/268 (2.61%)  8 8/267 (3.00%)  11
Tooth abscess  1  1/268 (0.37%)  1 4/267 (1.50%)  5
Upper respiratory tract infection  1  22/268 (8.21%)  24 21/267 (7.87%)  28
Urinary tract infection  1  4/268 (1.49%)  4 5/267 (1.87%)  5
Viral upper respiratory tract infection  1  3/268 (1.12%)  3 2/267 (0.75%)  3
Injury, poisoning and procedural complications     
Ligament sprain  1  3/268 (1.12%)  3 0/267 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/268 (1.12%)  3 5/267 (1.87%)  5
Back pain  1  10/268 (3.73%)  11 9/267 (3.37%)  9
Musculoskeletal pain  1  2/268 (0.75%)  2 5/267 (1.87%)  5
Neck pain  1  2/268 (0.75%)  2 3/267 (1.12%)  3
Pain in extremity  1  3/268 (1.12%)  3 2/267 (0.75%)  3
Nervous system disorders     
Dizziness  1  6/268 (2.24%)  7 0/267 (0.00%)  0
Headache  1  7/268 (2.61%)  7 7/267 (2.62%)  17
Psychiatric disorders     
Depression  1  3/268 (1.12%)  3 2/267 (0.75%)  2
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/268 (2.24%)  6 8/267 (3.00%)  9
Nasal congestion  1  3/268 (1.12%)  3 3/267 (1.12%)  6
Oropharyngeal pain  1  5/268 (1.87%)  5 4/267 (1.50%)  4
Sinus congestion  1  6/268 (2.24%)  7 5/267 (1.87%)  7
Upper respiratory tract inflammation  1  4/268 (1.49%)  5 2/267 (0.75%)  2
Skin and subcutaneous tissue disorders     
Acne  1  2/268 (0.75%)  2 3/267 (1.12%)  3
Dermatitis contact  1  1/268 (0.37%)  1 4/267 (1.50%)  4
Pruritus  1  3/268 (1.12%)  5 1/267 (0.37%)  1
Vascular disorders     
Hypertension  1  9/268 (3.36%)  9 5/267 (1.87%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1