Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study in Participants With Type 1 Diabetes Mellitus (IMAGINE 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: NCT01481779
Recruitment Status : Completed
First Posted : November 30, 2011
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
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: Glargine
Drug: LY2605541
Drug: Insulin Lispro
Enrollment 455
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks. Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Period Title: Overall Study
Started 295 160
Received at Least 1 Dose of Study Drug 294 159
Completed 225 132
Not Completed 70 28
Reason Not Completed
Adverse Event             23             5
Lost to Follow-up             3             2
Protocol Violation             2             3
Withdrawal by Subject             26             13
Physician Decision             13             4
Sponsor Decision             3             1
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro Total
Hide Arm/Group Description LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks. Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks. Total of all reporting groups
Overall Number of Baseline Participants 295 160 455
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 295 participants 160 participants 455 participants
39.68  (12.93) 38.91  (14.10) 39.41  (13.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 160 participants 455 participants
Female 157 73 230
Male 138 87 225
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 160 participants 455 participants
Hispanic or Latino 33 16 49
Not Hispanic or Latino 153 85 238
Unknown or Not Reported 109 59 168
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 160 participants 455 participants
American Indian or Alaska Native 6 3 9
Asian 63 31 94
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 5 0 5
White 221 125 346
More than one race 0 1 1
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 160 participants 455 participants
France 23 14 37
United States 85 45 130
Mexico 25 15 40
Poland 27 14 41
Austria 7 4 11
Russia 11 9 20
Germany 45 21 66
Japan 60 31 91
Italy 12 7 19
1.Primary Outcome
Title Hemoglobin A1c (HbA1c) at 26 Weeks
Hide Description HbA1c is a test that measures a participant’s average blood glucose level over a 2- to 3-month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM), adjusting for treatment, stratification factors (baseline low-density lipoprotein cholesterol [LDL-C] [<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 287 153
Least Squares Mean (Standard Error)
Unit of Measure: percentage of HbA1c
7.06  (0.04) 7.43  (0.06)
2.Secondary Outcome
Title Hemoglobin A1c (HbA1c)
Hide Description HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
Time Frame 52 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 287 153
Least Squares Mean (Standard Error)
Unit of Measure: percentage of HbA1c
Week 52 7.30  (0.05) 7.55  (0.06)
Week 78 7.43  (0.05) 7.70  (0.07)
3.Secondary Outcome
Title Change From Baseline in Hemoglobin A1c (HbA1c)
Hide Description HbA1c is a test that measures a participant’s average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
Time Frame Baseline, 26 weeks, 52 weeks, 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 287 153
Least Squares Mean (Standard Error)
Unit of Measure: percentage of HbA1c
Week 26 -0.69  (0.04) -0.33  (0.06)
Week 56 -0.46  (0.05) -0.21  (0.06)
Week 78 -0.33  (0.05) -0.05  (0.07)
4.Secondary Outcome
Title Percentage of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% or Less Than or Equal to 6.5% Using Last Observation Carried Forward (LOCF)
Hide Description HbA1c is a test that measures a participant’s average blood glucose level over a 2- to 3-month timeframe. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, then multiplying by 100.
Time Frame 26 weeks and 52 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 287 153
Measure Type: Number
Unit of Measure: percentage of participants
HbA1c ≤6.5%, Week 26 28.6 13.7
HbA1c ≤6.5%, Week 52 23.3 13.1
HbA1c ≤6.5%, Week 78 20.2 13.1
HbA1c <7.0%, Week 26 44.9 27.5
HbA1c <7.0%, Week 52 37.3 28.1
HbA1c <7.0%, Week 78 34.5 22.9
5.Secondary Outcome
Title Proportion of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% Without Nocturnal Hypoglycemia
Hide Description Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, then multiplying by 100.
Time Frame 26 weeks and 52 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable data. Missing endpoints were imputed with the LOCF method.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 287 153
Measure Type: Number
Unit of Measure: percentage of participants
Week 26 3.8 2.0
Week 52 2.1 0.7
Week 78 1.0 0.0
6.Secondary Outcome
Title Total Hypoglycemia Rates (Adjusted by 30 Days)
Hide Description Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Time Frame Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 293 159
Mean (Standard Error)
Unit of Measure: episodes/participant/30 days
Baseline-Week 26 16.01  (0.44) 12.43  (0.55)
Baseline-Week 52 14.84  (0.42) 11.75  (0.55)
Baseline-Week 78 14.33  (0.42) 11.43  (0.55)
7.Secondary Outcome
Title Percentage of Participants With Total Hypoglycemia Events
Hide Description Hypoglycemic events are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.
Time Frame Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 294 159
Measure Type: Number
Unit of Measure: percentage of participants
Baseline-Week 26 99.0 96.9
Baseline-Week 52 99.0 96.9
Baseline-Week 78 99.0 96.9
8.Secondary Outcome
Title Nocturnal Hypoglycemia Rates (Adjusted by 30 Days)
Hide Description Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Time Frame Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 293 159
Mean (Standard Error)
Unit of Measure: episodes/participant/30 days
Baseline-Week 26 1.69  (0.12) 2.66  (0.19)
Baseline-Week 52 1.63  (0.11) 2.45  (0.19)
Baseline-Week 78 1.58  (0.11) 2.28  (0.17)
9.Secondary Outcome
Title Percentage of Participants With Nocturnal Hypoglycemic Events
Hide Description Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.
Time Frame Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 294 159
Measure Type: Number
Unit of Measure: percentage of participants
Baseline-Week 26 87.4 90.6
Baseline-Week 52 91.5 91.8
Baseline-Week 78 93.5 92.5
10.Secondary Outcome
Title Fasting Serum Glucose (FSG) by Laboratory Measurement
Hide Description LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
Time Frame 26 weeks and 52 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 285 152
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 26 138.22  (3.80) 160.35  (5.06)
Week 52 146.55  (4.42) 164.28  (5.72)
Week 78 144.64  (4.53) 164.78  (5.81)
11.Secondary Outcome
Title Fasting Blood Glucose (FBG) Intra-participant Variability
Hide Description FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
Time Frame 26 weeks and 52 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 282 153
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 26 52.49  (1.79) 59.25  (2.43)
Week 52 53.44  (1.85) 58.15  (2.43)
Week 78 54.87  (2.20) 60.66  (2.79)
12.Secondary Outcome
Title 0300-hour Blood Glucose (BG) to Fasting Blood (FBG) Glucose Excursion
Hide Description Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion). LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Time Frame 26 weeks and 52 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 209 112
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 26 -9.92  (6.24) -14.08  (8.75)
Week 52 -6.15  (6.91) -9.02  (9.58)
Week 78 -10.82  (8.25) -28.94  (10.50)
13.Secondary Outcome
Title 9 Point Self-monitored Blood Glucose (SMBG)
Hide Description 9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, 52, 65, and 78. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the pre-morning meal the next day. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Time Frame 26 weeks and 52 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 271 143
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Pre-morning meal, Week 26 Number Analyzed 271 participants 143 participants
158.58  (3.82) 144.40  (5.20)
Pre-morning meal, Week 52 Number Analyzed 271 participants 143 participants
160.89  (4.13) 152.55  (5.38)
Pre-morning meal, Week 78 Number Analyzed 271 participants 143 participants
163.09  (4.66) 153.38  (5.99)
2 hours post-morning meal, Week 26 Number Analyzed 245 participants 125 participants
172.39  (4.59) 165.53  (6.44)
2 hours post-morning meal, Week 52 Number Analyzed 245 participants 125 participants
176.32  (5.61) 168.38  (7.47)
2 hours post-morning meal, Week 78 Number Analyzed 245 participants 125 participants
183.64  (6.23) 190.54  (7.91)
Pre-midday meal, Week 26 Number Analyzed 264 participants 140 participants
136.21  (3.92) 153.12  (5.33)
Pre-midday meal, Week 52 Number Analyzed 264 participants 140 participants
142.82  (4.27) 149.78  (5.66)
Pre-midday meal, Week 78 Number Analyzed 264 participants 140 participants
150.83  (4.90) 154.56  (6.33)
2 hours post-midday meal, Week 26 Number Analyzed 244 participants 122 participants
157.17  (4.78) 164.75  (6.69)
2 hours post-midday meal, Week 52 Number Analyzed 244 participants 122 participants
159.59  (5.11) 168.83  (6.94)
2 hours post-midday meal, Week 78 Number Analyzed 244 participants 122 participants
154.46  (5.76) 175.52  (7.51)
Pre-evening meal, Week 26 Number Analyzed 266 participants 143 participants
153.20  (4.29) 168.08  (5.75)
Pre-evening meal, Week 52 Number Analyzed 266 participants 143 participants
153.01  (5.17) 183.18  (6.81)
Pre-evening meal, Week 78 Number Analyzed 266 participants 143 participants
149.89  (4.92) 174.50  (6.17)
2 hours post-evening meal, Week 26 Number Analyzed 232 participants 126 participants
149.74  (5.17) 191.99  (7.20)
2 hours post-evening meal, Week 52 Number Analyzed 232 participants 126 participants
157.81  (6.79) 198.10  (9.06)
2 hours post-evening meal, Week 78 Number Analyzed 232 participants 126 participants
163.27  (6.07) 189.43  (7.75)
Bedtime, Week 26 Number Analyzed 250 participants 137 participants
151.66  (4.15) 176.17  (5.63)
Bedtime, Week 52 Number Analyzed 250 participants 137 participants
167.35  (5.33) 182.08  (7.11)
Bedtime, Week 78 Number Analyzed 250 participants 137 participants
165.63  (5.37) 185.45  (6.74)
0300 hours, Week 26 Number Analyzed 219 participants 116 participants
159.73  (5.30) 163.18  (7.50)
0300 hours, Week 52 Number Analyzed 219 participants 116 participants
157.52  (6.06) 148.26  (8.36)
0300 hours, Week 78 Number Analyzed 219 participants 116 participants
165.82  (7.19) 170.35  (9.02)
Pre-morning meal next day, Week 26 Number Analyzed 260 participants 138 participants
149.94  (3.74) 143.89  (5.10)
Pre-morning meal next day, Week 52 Number Analyzed 260 participants 138 participants
155.79  (4.24) 145.55  (5.59)
Pre-morning meal next day, Week 78 Number Analyzed 260 participants 138 participants
156.87  (4.80) 152.63  (6.11)
14.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
Time Frame Baseline and 26 weeks and 52 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 287 154
Least Squares Mean (Standard Error)
Unit of Measure: kilograms (kg)
Week 26 -1.17  (0.20) 0.71  (0.27)
Week 52 -1.22  (0.25) 1.00  (0.33)
Week 78 -0.93  (0.28) 1.04  (0.37)
15.Secondary Outcome
Title Basal, Bolus, and Total Insulin Dose
Hide Description Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Time Frame 26 weeks and 52 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 282 156
Least Squares Mean (Standard Error)
Unit of Measure: units/kg/day
Basal Insulin, Week 26 Number Analyzed 239 participants 127 participants
0.40  (0.01) 0.34  (0.01)
Basal Insulin, Week 52 Number Analyzed 239 participants 127 participants
0.40  (0.01) 0.34  (0.01)
Basal Insulin, Week 78 Number Analyzed 239 participants 127 participants
0.41  (0.01) 0.35  (0.01)
Bolus Insulin, Week 26 Number Analyzed 280 participants 153 participants
0.37  (0.01) 0.46  (0.02)
Bolus Insulin, Week 52 Number Analyzed 280 participants 153 participants
0.38  (0.01) 0.47  (0.02)
Bolus Insulin, Week 78 Number Analyzed 280 participants 153 participants
0.37  (0.02) 0.48  (0.02)
Total Insulin, Week 26 Number Analyzed 282 participants 156 participants
0.73  (0.02) 0.78  (0.02)
Total Insulin, Week 52 Number Analyzed 282 participants 156 participants
0.74  (0.02) 0.79  (0.03)
Total Insulin, Week 78 Number Analyzed 282 participants 156 participants
0.75  (0.02) 0.80  (0.03)
16.Secondary Outcome
Title Lipid Profile
Hide Description Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM, adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL] except for the LDL-C outcome variable), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable.
Time Frame 26 weeks and 52 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 288 152
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Cholesterol, Week 26 191.86  (1.63) 187.93  (2.19)
Cholesterol, Week 52 190.72  (1.59) 188.65  (2.10)
Cholesterol, Week 78 191.78  (1.86) 190.06  (2.39)
HDL-C, Week 26 61.87  (0.59) 62.75  (0.80)
HDL-C, Week 52 61.01  (0.56) 61.46  (0.74)
HDL-C, Week 78 60.77  (0.66) 61.97  (0.85)
LDL-C, Week 26 108.85  (1.33) 108.31  (1.79)
LDL-C, Week 52 109.40  (1.39) 109.74  (1.84)
LDL-C, Week 78 109.62  (1.62) 110.35  (2.09)
Triglycerides, Week 26 109.64  (3.89) 85.35  (5.24)
Triglycerides, Week 52 105.17  (3.64) 87.94  (4.80)
Triglycerides, Week 78 110.80  (4.78) 88.96  (6.14)
17.Secondary Outcome
Title Percentage of Participants With Change in Anti-LY2605541 Antibodies
Hide Description The percentage of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable or from detectable to the value with at least 130% relative increase from baseline.
Time Frame Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline. Missing endpoints were imputed with the LOCF method.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 288 153
Measure Type: Number
Unit of Measure: percentage of participants
Week 26 Number Analyzed 288 participants 152 participants
30.6 15.8
Week 52 Number Analyzed 288 participants 152 participants
29.9 17.1
Week 78 Number Analyzed 288 participants 153 participants
26.4 13.1
18.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. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline value of the dependent variable as a covariate.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 273 149
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
72.43  (0.69) 73.91  (0.94)
19.Secondary Outcome
Title Low Blood Sugar Survey (LBSS)
Hide Description LBSS (also referenced as Hypoglycemia Fear Survey – II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%] and country), visit, treatment-by-visit interaction , and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Time Frame 26 weeks and 52 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 287 151
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 26 28.09  (0.70) 27.09  (0.95)
Week 52 27.76  (0.77) 27.00  (1.01)
Week 78 27.68  (0.91) 27.14  (1.18)
20.Secondary Outcome
Title European Quality of Life-5 Dimension (EQ-5D)
Hide Description The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using ANCOVA, adjusting for treatment and stratification factors (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline EQ-5D score as a covariate.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable EQ-5D data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 277 150
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.92  (0.01) 0.91  (0.01)
21.Secondary Outcome
Title Rapid Assessment of Physical Activity (RAPA)
Hide Description The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant’s amount and intensity of physical activity, allowing each participant’s aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants’ physical activities that increase strength and improve flexibility. Each participant’s strength and flexibility activity level is then categorized as neither strength nor flexibility (flex) activity, either strength or flex (not both), both strength and flex activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, then multiplying by 100.
Time Frame 26 weeks and 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, had at least 1 dose of study medication, and had evaluable RAPA data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description:
LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Overall Number of Participants Analyzed 98 57
Measure Type: Number
Unit of Measure: percentage of participants
RAPA 1, Sedentary, Week 26 Number Analyzed 98 participants 57 participants
1.0 0.0
RAPA 1, Sedentary, Week 78 Number Analyzed 80 participants 51 participants
1.3 0.0
RAPA 1, Underactive, Week 26 Number Analyzed 98 participants 57 participants
3.1 3.5
RAPA 1, Underactive, Week 78 Number Analyzed 80 participants 51 participants
3.8 2.0
RAPA 1, Light activity, Week 26 Number Analyzed 98 participants 57 participants
13.3 10.5
RAPA 1, Light activity, Week 78 Number Analyzed 80 participants 51 participants
7.5 13.7
RAPA 1, Regular underactive, Week 26 Number Analyzed 98 participants 57 participants
24.5 29.8
RAPA 1, Regular underactive, Week 78 Number Analyzed 80 participants 51 participants
31.3 29.4
RAPA 1, Active, Week 26 Number Analyzed 98 participants 57 participants
58.2 56.1
RAPA 1, Active, Week 78 Number Analyzed 80 participants 51 participants
56.3 54.9
RAPA 2, Neither strength/flex, Week 26 Number Analyzed 98 participants 57 participants
35.7 43.9
RAPA 2, Neither strength/flex, Week 78 Number Analyzed 81 participants 51 participants
37.0 47.1
RAPA 2, Either strength/flex, Week 26 Number Analyzed 98 participants 57 participants
30.6 35.1
RAPA 2, Either strength/flex, Week 78 Number Analyzed 81 participants 51 participants
33.3 29.4
RAPA 2, Both strength/flex, Week 26 Number Analyzed 98 participants 57 participants
33.7 21.1
RAPA 2, Both strength/flex, Week 78 Number Analyzed 81 participants 51 participants
29.6 23.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Hide Arm/Group Description LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered subcutaneously via pen device at meal times for 78 weeks. Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
All-Cause Mortality
LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/294 (22.79%)      25/159 (15.72%)    
Cardiac disorders     
Atrial fibrillation  1  3/294 (1.02%)  4 1/159 (0.63%)  1
Cardiomyopathy  1  0/294 (0.00%)  0 1/159 (0.63%)  4
Ear and labyrinth disorders     
Sudden hearing loss  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Tympanic membrane perforation  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Gastrointestinal disorders     
Faeces pale  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Impaired gastric emptying  1  0/294 (0.00%)  0 1/159 (0.63%)  2
Pancreatitis  1  2/294 (0.68%)  2 0/159 (0.00%)  0
Pancreatitis acute  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Small intestinal perforation  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Hepatobiliary disorders     
Hepatic function abnormal  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Immune system disorders     
Anaphylactic shock  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Infections and infestations     
Abscess limb  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Cellulitis  1  1/294 (0.34%)  2 0/159 (0.00%)  0
Chronic sinusitis  1  1/294 (0.34%)  3 0/159 (0.00%)  0
Diabetic gangrene  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Gastroenteritis  1  2/294 (0.68%)  2 0/159 (0.00%)  0
Infectious mononucleosis  1  1/294 (0.34%)  2 0/159 (0.00%)  0
Osteomyelitis  1  2/294 (0.68%)  4 1/159 (0.63%)  3
Pneumonia  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Pneumonia bacterial  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Post procedural sepsis  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Pseudomonas infection  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Sepsis  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Staphylococcal sepsis  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Injury, poisoning and procedural complications     
Alcohol poisoning  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Clavicle fracture  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Fall  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Incorrect dose administered  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Intentional overdose  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Lower limb fracture  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Overdose  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Road traffic accident  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Tibia fracture  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  1/294 (0.34%)  1 1/159 (0.63%)  1
Hypoglycaemia  1  45/294 (15.31%)  73 13/159 (8.18%)  20
Hyponatraemia  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Ketoacidosis  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Metabolic disorder  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc degeneration  1  1/294 (0.34%)  2 0/159 (0.00%)  0
Intervertebral disc protrusion  1  1/294 (0.34%)  1 1/159 (0.63%)  1
Lumbar spinal stenosis  1  1/294 (0.34%)  2 0/159 (0.00%)  0
Muscle contracture  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Spondylolisthesis  1  1/294 (0.34%)  2 0/159 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Basal cell carcinoma  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Benign bone neoplasm  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Breast cancer  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Cervix carcinoma  1  1/157 (0.64%)  1 0/73 (0.00%)  0
Fibroadenoma of breast  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Uterine leiomyoma  1  2/157 (1.27%)  5 0/73 (0.00%)  0
Nervous system disorders     
Complicated migraine  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Dizziness  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Hypoglycaemic coma  1  1/294 (0.34%)  3 0/159 (0.00%)  0
Psychiatric disorders     
Adjustment disorder  1  1/294 (0.34%)  3 0/159 (0.00%)  0
Suicide attempt  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Renal and urinary disorders     
Renal failure acute  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Urinary incontinence  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Reproductive system and breast disorders     
Cervical polyp  1  1/157 (0.64%)  2 0/73 (0.00%)  0
Menorrhagia  1  1/157 (0.64%)  2 0/73 (0.00%)  0
Ovarian cyst  1  1/157 (0.64%)  2 0/73 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Pulmonary embolism  1  1/294 (0.34%)  1 0/159 (0.00%)  0
Pulmonary oedema  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Skin and subcutaneous tissue disorders     
Skin ulcer  1  2/294 (0.68%)  5 0/159 (0.00%)  0
Surgical and medical procedures     
Hysterectomy  1  1/157 (0.64%)  1 0/73 (0.00%)  0
Toe amputation  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Vascular disorders     
Intermittent claudication  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Peripheral arterial occlusive disease  1  1/294 (0.34%)  2 0/159 (0.00%)  0
Peripheral artery stenosis  1  0/294 (0.00%)  0 1/159 (0.63%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
LY2605541 + Insulin Lispro Glargine + Insulin Lispro
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   256/294 (87.07%)      112/159 (70.44%)    
Gastrointestinal disorders     
Diarrhoea  1  13/294 (4.42%)  15 3/159 (1.89%)  3
Infections and infestations     
Bronchitis  1  11/294 (3.74%)  12 4/159 (2.52%)  4
Cystitis  1  9/294 (3.06%)  10 3/159 (1.89%)  3
Gastroenteritis  1  11/294 (3.74%)  11 8/159 (5.03%)  9
Gastroenteritis viral  1  4/294 (1.36%)  4 5/159 (3.14%)  6
Influenza  1  25/294 (8.50%)  32 14/159 (8.81%)  14
Nasopharyngitis  1  92/294 (31.29%)  152 38/159 (23.90%)  61
Pharyngitis  1  13/294 (4.42%)  19 7/159 (4.40%)  9
Upper respiratory tract infection  1  13/294 (4.42%)  22 12/159 (7.55%)  17
Urinary tract infection  1  15/294 (5.10%)  17 8/159 (5.03%)  14
Investigations     
Alanine aminotransferase increased  1  12/294 (4.08%)  20 1/159 (0.63%)  1
Weight increased  1  4/294 (1.36%)  4 6/159 (3.77%)  6
Musculoskeletal and connective tissue disorders     
Back pain  1  15/294 (5.10%)  17 7/159 (4.40%)  7
Nervous system disorders     
Headache  1  18/294 (6.12%)  27 10/159 (6.29%)  13
Psychiatric disorders     
Depression  1  2/294 (0.68%)  2 5/159 (3.14%)  5
Respiratory, thoracic and mediastinal disorders     
Cough  1  9/294 (3.06%)  12 5/159 (3.14%)  6
Skin and subcutaneous tissue disorders     
Lipodystrophy acquired  1  17/294 (5.78%)  24 1/159 (0.63%)  1
Lipohypertrophy  1  45/294 (15.31%)  66 0/159 (0.00%)  0
Vascular disorders     
Hypertension  1  10/294 (3.40%)  10 1/159 (0.63%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01481779     History of Changes
Other Study ID Numbers: 12146
I2R-MC-BIAN ( Other Identifier: Eli Lilly and Company )
2011-001261-40 ( EudraCT Number )
First Submitted: November 28, 2011
First Posted: November 30, 2011
Results First Submitted: March 16, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018