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A Study in Participants With Type 2 Diabetes Mellitus (IMAGINE 4)

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ClinicalTrials.gov Identifier: NCT01468987
Recruitment Status : Completed
First Posted : November 10, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: LY2605541
Drug: Insulin Glargine
Drug: Insulin Lispro
Enrollment 1369
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description

Includes participants that were randomized to receive LY2605541 plus Insulin Lispro.

Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.

Includes participants that were randomized to receive Insulin Glargine plus Insulin Lispro.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Period Title: Overall Study
Started 691 678
Received at Least 1 Dose of Study Drug 691 677
Completed 620 618
Not Completed 71 60
Reason Not Completed
Adverse Event             12             9
Death             4             1
Lost to Follow-up             10             5
Protocol Violation             8             2
Withdrawal by Subject             28             28
Physician Decision             8             15
Sponsor Decision             1             0
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro Total
Hide Arm/Group Description

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 691 678 1369
Hide Baseline Analysis Population Description
All participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 691 participants 678 participants 1369 participants
57.43  (9.21) 57.77  (9.17) 57.6  (9.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 691 participants 678 participants 1369 participants
Female 315 274 589
Male 376 404 780
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 691 participants 678 participants 1369 participants
Hispanic or Latino 74 78 152
Not Hispanic or Latino 452 427 879
Unknown or Not Reported 165 173 338
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 691 participants 678 participants 1369 participants
American Indian or Alaska Native 2 2 4
Asian 25 30 55
Native Hawaiian or Other Pacific Islander 2 2 4
Black or African American 42 50 92
White 615 585 1200
More than one race 5 9 14
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 691 participants 678 participants 1369 participants
United States 276 270 546
Taiwan 7 8 15
Slovakia 25 17 42
Greece 12 11 23
Spain 30 35 65
Lithuania 4 2 6
Turkey 4 7 11
Austria 9 6 15
Russia 19 20 39
Israel 20 20 40
United Kingdom 5 3 8
Italy 16 16 32
Czechia 23 22 45
Hungary 36 36 72
Mexico 13 12 25
Puerto Rico 20 26 46
Poland 20 20 40
Brazil 11 13 24
Romania 34 31 65
Croatia 5 2 7
Denmark 9 3 12
Australia 26 25 51
Netherlands 7 8 15
Germany 50 54 104
Japan 10 11 21
1.Primary Outcome
Title Change From Baseline in 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 stratification factors (country, low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Time Frame Baseline, 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 Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 684 672
Least Squares Mean (Standard Error)
Unit of Measure: percentage of HbA1c
-1.66  (0.04) -1.45  (0.04)
2.Secondary Outcome
Title Total Hypoglycemia Rates (Adjusted for 30 Days)
Hide Description Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter [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
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 Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 689 676
Mean (Standard Error)
Unit of Measure: episodes/participant/30 days
5.97  (0.20) 5.42  (0.19)
3.Secondary Outcome
Title Percentage of Participants With Total Hypoglycemia Episodes
Hide Description Hypoglycemic episodes are defined as events which 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, multiplied by 100.
Time Frame Baseline through 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 data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 689 676
Measure Type: Number
Unit of Measure: percentage of participants
95.2 96.6
4.Secondary Outcome
Title Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)
Hide Description Hypoglycemic episodes are defined as events which 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
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 Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 689 676
Mean (Standard Error)
Unit of Measure: events/participant/30 days
0.51  (0.03) 0.92  (0.05)
5.Secondary Outcome
Title Percentage of Participants With Nocturnal Hypoglycemia Episodes
Hide Description Hypoglycemic episodes are defined as an event which 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, multiplied by 100.
Time Frame Baseline through 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 data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine were administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 689 676
Measure Type: Number
Unit of Measure: percentage of participants
59.5 74.0
6.Secondary Outcome
Title Body Weight Change From Baseline to 26 Weeks
Hide Description 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], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline body weight as fixed effects, and participant as a random effect.
Time Frame Baseline, 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 body weight data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 682 671
Least Squares Mean (Standard Error)
Unit of Measure: kilograms (kg)
1.25  (0.16) 2.21  (0.16)
7.Secondary Outcome
Title Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks
Hide Description 9-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to Weeks 0, 4, 12, and 26. 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 subsequent morning prior to the morning meal. 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], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline BG values.
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 SMBG data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 639 619
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Pre-morning meal Number Analyzed 639 participants 619 participants
137.31  (1.63) 133.81  (1.66)
2 hours post-morning meal Number Analyzed 545 participants 538 participants
162.77  (2.59) 156.41  (2.64)
Pre-midday meal Number Analyzed 606 participants 584 participants
130.02  (1.97) 133.63  (2.02)
2 hours post-midday meal Number Analyzed 548 participants 550 participants
145.55  (2.67) 156.17  (2.72)
Pre-evening meal Number Analyzed 611 participants 595 participants
142.65  (2.09) 149.19  (2.14)
2 hours post-evening meal Number Analyzed 552 participants 536 participants
156.56  (2.72) 166.59  (2.85)
Bedtime Number Analyzed 587 participants 557 participants
160.15  (2.60) 163.62  (2.70)
0300 hours Number Analyzed 516 participants 487 participants
143.90  (2.54) 140.19  (2.59)
Pre-morning meal next day Number Analyzed 605 participants 588 participants
135.09  (1.77) 132.07  (1.81)
8.Secondary Outcome
Title Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks
Hide Description The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Time Frame up to 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. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 684 672
Measure Type: Number
Unit of Measure: percentage of participants
HbA1c ≤6.5% 44.4 32.6
HbA1c <7.0% 63.3 53.3
9.Secondary Outcome
Title Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks
Hide Description Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose 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 HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.
Time Frame up to 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. Missing endpoints were imputed with the LOCF method, using only post-baseline data.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 684 672
Measure Type: Number
Unit of Measure: percentage of participants
23.7 12.2
10.Secondary Outcome
Title Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks
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 a constrained Longitudinal Data Analysis (cLDA) model adjusting for indicator variables of each treatment group at each post-baseline visit and stratification variables (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and baseline number of insulin injections [1, 2, or ≥3]).
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 insulin dose data.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 615 613
Least Squares Mean (Standard Error)
Unit of Measure: units/kg/day
Basal Insulin Number Analyzed 612 participants 606 participants
0.68  (0.01) 0.60  (0.01)
Bolus Insulin Number Analyzed 591 participants 591 participants
0.61  (0.02) 0.63  (0.02)
Total Insulin Number Analyzed 615 participants 613 participants
1.27  (0.02) 1.21  (0.02)
11.Secondary Outcome
Title Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks
Hide Description 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], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FSG.
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 FSG data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 683 672
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
125.33  (1.93) 132.02  (1.94)
12.Secondary Outcome
Title Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks
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 the stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FBG variability.
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 FBG data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 674 652
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
28.67  (0.79) 33.54  (0.80)
13.Secondary Outcome
Title 0300-hour Blood Glucose to FBG Excursion at 26 Weeks
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 stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline excursion.
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 SMBG data at baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 470 450
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-11.95  (2.34) -15.16  (2.37)
14.Secondary Outcome
Title HbA1c at 26 Weeks
Hide Description HbA1c is a test that measures a participant’s average blood glucose level over the past 2 to 3 months. LS means were calculated using MMRM adjusting for stratification factors (country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
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 Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 684 672
Least Squares Mean (Standard Error)
Unit of Measure: percentage of HbA1c
6.76  (0.04) 6.97  (0.04)
15.Secondary Outcome
Title Lipid Profile at 26 Weeks
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], number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.
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 lipid data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 684 674
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Cholesterol Number Analyzed 613 participants 609 participants
177.17  (1.13) 174.79  (1.14)
HDL-C Number Analyzed 611 participants 603 participants
46.44  (0.27) 47.71  (0.27)
LDL-C Number Analyzed 609 participants 603 participants
97.87  (0.99) 98.89  (0.99)
Triglycerides Number Analyzed 614 participants 609 participants
168.79  (2.85) 141.78  (2.86)
16.Secondary Outcome
Title Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks
Hide Description The number 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
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.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine were administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 682 672
Measure Type: Number
Unit of Measure: participants
152 161
17.Secondary Outcome
Title Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks
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, 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 factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥3]) as fixed effects and baseline value of the ITSQ scores as a covariate.
Time Frame up to 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 Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 631 637
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
77.01  (0.55) 77.29  (0.54)
18.Secondary Outcome
Title Low Blood Sugar Survey (LBSS) at 26 Weeks
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 including stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline number of insulin injections [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline LBSS score.
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 LBSS data at both baseline and post-baseline.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 682 671
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
21.44  (0.56) 21.67  (0.56)
19.Secondary Outcome
Title EuroQoL-5D (EQ-5D) at 26 Weeks
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 three 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, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥ 3]), and baseline EQ-5D score.
Time Frame up to 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 Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 636 644
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.86  (0.00) 0.85  (0.00)
20.Secondary Outcome
Title Rapid Assessment of Physical Activity (RAPA) at 26 Weeks
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 activity, either strength or flexibility activity (not both), both strength and flexibility 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, multiplied by 100.
Time Frame up to 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 RAPA data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description:

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Overall Number of Participants Analyzed 331 346
Measure Type: Number
Unit of Measure: percentage of participants
RAPA 1, Sedentary Number Analyzed 324 participants 339 participants
2.2 2.4
RAPA 1, Underactive Number Analyzed 324 participants 339 participants
4.6 6.2
RAPA 1, Light activity Number Analyzed 324 participants 339 participants
21.9 18.0
RAPA 1, Regular underactive Number Analyzed 324 participants 339 participants
32.7 27.1
RAPA 1, Active Number Analyzed 324 participants 339 participants
38.6 46.3
RAPA 2, Neither strength/flexibility Number Analyzed 331 participants 346 participants
58.3 53.8
RAPA 2, Either strength/flexibility Number Analyzed 331 participants 346 participants
28.1 30.6
RAPA 2, Both strength/flexibility Number Analyzed 331 participants 346 participants
13.6 15.6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Hide Arm/Group Description

Participant-specific doses of LY2605541 were administered SC once daily at bedtime for 26 weeks.

Participant-specific doses of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks.

Participant-specific doses of Insulin Glargine were administered SC once daily at bedtime for 26 weeks.

Participant-specific doses of Insulin Lispro were administered SC for preprandial and supplemental doses for 26 weeks.

All-Cause Mortality
LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   79/691 (11.43%)      63/677 (9.31%)    
Blood and lymphatic system disorders     
Anaemia  1  1/691 (0.14%)  1 1/677 (0.15%)  1
Cardiac disorders     
Acute myocardial infarction  1  1/691 (0.14%)  1 1/677 (0.15%)  1
Angina pectoris  1  1/691 (0.14%)  1 2/677 (0.30%)  2
Angina unstable  1  1/691 (0.14%)  1 1/677 (0.15%)  1
Atrial fibrillation  1  2/691 (0.29%)  2 1/677 (0.15%)  2
Cardiac arrest  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Cardiac failure  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Cardiac failure acute  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Cardio-respiratory arrest  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Coronary artery disease  1  3/691 (0.43%)  4 2/677 (0.30%)  2
Coronary artery stenosis  1  3/691 (0.43%)  3 0/677 (0.00%)  0
Hypertensive heart disease  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Myocardial infarction  1  2/691 (0.29%)  2 1/677 (0.15%)  1
Nodal arrhythmia  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Ventricular tachycardia  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Ear and labyrinth disorders     
Inner ear disorder  1  1/691 (0.14%)  2 0/677 (0.00%)  0
Vertigo  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Endocrine disorders     
Hyperparathyroidism primary  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Eye disorders     
Cataract  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Panophthalmitis  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Gastrointestinal disorders     
Abdominal pain  1  0/691 (0.00%)  0 2/677 (0.30%)  2
Anal fistula  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Bezoar  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Crohn's disease  1  1/691 (0.14%)  2 0/677 (0.00%)  0
Diarrhoea  1  1/691 (0.14%)  3 0/677 (0.00%)  0
Haematochezia  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Inguinal hernia  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Large intestine polyp  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Oesophagitis  1  1/691 (0.14%)  3 0/677 (0.00%)  0
Pancreatitis  1  0/691 (0.00%)  0 1/677 (0.15%)  2
Small intestinal obstruction  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Umbilical hernia  1  0/691 (0.00%)  0 1/677 (0.15%)  1
General disorders     
Chest pain  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Death  1  1/691 (0.14%)  1 1/677 (0.15%)  1
Medical device complication  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Non-cardiac chest pain  1  2/691 (0.29%)  2 0/677 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Cholelithiasis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Drug-induced liver injury  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Hepatic cirrhosis  1  0/691 (0.00%)  0 1/677 (0.15%)  2
Immune system disorders     
Anaphylactic shock  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Drug hypersensitivity  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Hypersensitivity  1  0/691 (0.00%)  0 2/677 (0.30%)  2
Sarcoidosis  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Infections and infestations     
Appendicitis  1  2/691 (0.29%)  2 0/677 (0.00%)  0
Bronchitis  1  2/691 (0.29%)  2 1/677 (0.15%)  2
Cellulitis  1  3/691 (0.43%)  6 1/677 (0.15%)  1
Diabetic foot infection  1  1/691 (0.14%)  1 1/677 (0.15%)  1
Enterococcal infection  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Incision site infection  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Infected skin ulcer  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Infectious mononucleosis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Osteomyelitis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Pneumonia  1  3/691 (0.43%)  3 3/677 (0.44%)  3
Rotavirus infection  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Subcutaneous abscess  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Viral infection  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Wound infection  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Injury, poisoning and procedural complications     
Acetabulum fracture  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Bone contusion  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Contusion  1  1/691 (0.14%)  2 1/677 (0.15%)  1
Coronary artery restenosis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Excoriation  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Fall  1  1/691 (0.14%)  1 2/677 (0.30%)  2
Femur fracture  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Head injury  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Injury  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Lower limb fracture  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Medication error  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Road traffic accident  1  2/691 (0.29%)  2 2/677 (0.30%)  2
Skull fractured base  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Subdural haematoma  1  0/691 (0.00%)  0 2/677 (0.30%)  3
Tibia fracture  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Traumatic haematoma  1  1/691 (0.14%)  2 0/677 (0.00%)  0
Upper limb fracture  1  1/691 (0.14%)  1 1/677 (0.15%)  1
Investigations     
Catheterisation cardiac  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Metabolism and nutrition disorders     
Fluid overload  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Hypoglycaemia  1  18/691 (2.60%)  21 12/677 (1.77%)  15
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/691 (0.14%)  2 0/677 (0.00%)  0
Bursitis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Exostosis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Intervertebral disc protrusion  1  1/691 (0.14%)  1 1/677 (0.15%)  1
Mobility decreased  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Musculoskeletal chest pain  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Myalgia  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Osteoarthritis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Rhabdomyolysis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Rotator cuff syndrome  1  1/691 (0.14%)  2 0/677 (0.00%)  0
Spinal column stenosis  1  0/691 (0.00%)  0 2/677 (0.30%)  5
Spinal disorder  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Breast cancer  1  0/691 (0.00%)  0 2/677 (0.30%)  2
Large intestine benign neoplasm  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Ovarian cancer  1  1/315 (0.32%)  1 0/273 (0.00%)  0
Prostate cancer  1  1/376 (0.27%)  1 0/404 (0.00%)  0
Prostate cancer metastatic  1  0/376 (0.00%)  0 1/404 (0.25%)  1
Rectal adenocarcinoma  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Nervous system disorders     
Carotid artery stenosis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Cerebrovascular accident  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Diabetic hyperosmolar coma  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Hypoglycaemic unconsciousness  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Ischaemic stroke  1  2/691 (0.29%)  2 0/677 (0.00%)  0
Transient ischaemic attack  1  3/691 (0.43%)  3 1/677 (0.15%)  1
Psychiatric disorders     
Adjustment disorder  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Depression  1  2/691 (0.29%)  4 0/677 (0.00%)  0
Panic attack  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Renal and urinary disorders     
Calculus ureteric  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Nephrolithiasis  1  1/691 (0.14%)  1 1/677 (0.15%)  1
Renal failure acute  1  0/691 (0.00%)  0 2/677 (0.30%)  2
Renal failure chronic  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Urinary tract obstruction  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Reproductive system and breast disorders     
Postmenopausal haemorrhage  1  0/315 (0.00%)  0 1/273 (0.37%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Dyspnoea exertional  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Pleural effusion  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Pulmonary congestion  1  0/691 (0.00%)  0 1/677 (0.15%)  2
Pulmonary oedema  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Respiratory distress  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Skin and subcutaneous tissue disorders     
Blister  1  1/691 (0.14%)  2 0/677 (0.00%)  0
Surgical and medical procedures     
Coronary arterial stent insertion  1  1/691 (0.14%)  1 1/677 (0.15%)  1
Knee arthroplasty  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Hypertensive crisis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Intermittent claudication  1  0/691 (0.00%)  0 1/677 (0.15%)  1
Peripheral arterial occlusive disease  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Subclavian artery stenosis  1  1/691 (0.14%)  1 0/677 (0.00%)  0
Venous insufficiency  1  0/691 (0.00%)  0 1/677 (0.15%)  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 1%
LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   408/691 (59.04%)      406/677 (59.97%)    
Eye disorders     
Diabetic retinopathy  1  7/691 (1.01%)  8 5/677 (0.74%)  5
Gastrointestinal disorders     
Abdominal pain  1  7/691 (1.01%)  7 4/677 (0.59%)  4
Constipation  1  9/691 (1.30%)  9 6/677 (0.89%)  6
Diarrhoea  1  24/691 (3.47%)  27 19/677 (2.81%)  22
Gastrooesophageal reflux disease  1  7/691 (1.01%)  7 4/677 (0.59%)  4
Nausea  1  16/691 (2.32%)  16 9/677 (1.33%)  10
Vomiting  1  11/691 (1.59%)  11 10/677 (1.48%)  13
General disorders     
Asthenia  1  0/691 (0.00%)  0 7/677 (1.03%)  7
Fatigue  1  6/691 (0.87%)  8 16/677 (2.36%)  16
Oedema peripheral  1  11/691 (1.59%)  11 26/677 (3.84%)  31
Pyrexia  1  8/691 (1.16%)  8 7/677 (1.03%)  7
Infections and infestations     
Bronchitis  1  20/691 (2.89%)  21 20/677 (2.95%)  22
Gastroenteritis  1  8/691 (1.16%)  9 16/677 (2.36%)  16
Gastroenteritis viral  1  12/691 (1.74%)  12 6/677 (0.89%)  6
Influenza  1  18/691 (2.60%)  19 16/677 (2.36%)  17
Nasopharyngitis  1  49/691 (7.09%)  58 63/677 (9.31%)  69
Pharyngitis  1  3/691 (0.43%)  3 7/677 (1.03%)  7
Sinusitis  1  16/691 (2.32%)  19 12/677 (1.77%)  13
Upper respiratory tract infection  1  29/691 (4.20%)  33 32/677 (4.73%)  39
Urinary tract infection  1  18/691 (2.60%)  19 23/677 (3.40%)  26
Injury, poisoning and procedural complications     
Contusion  1  4/691 (0.58%)  6 8/677 (1.18%)  9
Muscle strain  1  3/691 (0.43%)  3 7/677 (1.03%)  9
Investigations     
Alanine aminotransferase increased  1  11/691 (1.59%)  12 2/677 (0.30%)  3
Aspartate aminotransferase increased  1  7/691 (1.01%)  7 1/677 (0.15%)  1
Blood creatine phosphokinase increased  1  2/691 (0.29%)  2 9/677 (1.33%)  9
Weight increased  1  5/691 (0.72%)  5 8/677 (1.18%)  8
Musculoskeletal and connective tissue disorders     
Arthralgia  1  15/691 (2.17%)  17 15/677 (2.22%)  20
Back pain  1  22/691 (3.18%)  25 23/677 (3.40%)  25
Musculoskeletal pain  1  6/691 (0.87%)  7 8/677 (1.18%)  10
Pain in extremity  1  10/691 (1.45%)  10 14/677 (2.07%)  14
Nervous system disorders     
Carpal tunnel syndrome  1  10/691 (1.45%)  11 1/677 (0.15%)  1
Dizziness  1  9/691 (1.30%)  11 10/677 (1.48%)  10
Headache  1  12/691 (1.74%)  12 19/677 (2.81%)  20
Hypoaesthesia  1  7/691 (1.01%)  8 7/677 (1.03%)  9
Psychiatric disorders     
Depression  1  4/691 (0.58%)  4 7/677 (1.03%)  7
Respiratory, thoracic and mediastinal disorders     
Cough  1  11/691 (1.59%)  11 12/677 (1.77%)  12
Dyspnoea  1  5/691 (0.72%)  5 7/677 (1.03%)  7
Skin and subcutaneous tissue disorders     
Lipohypertrophy  1  9/691 (1.30%)  11 0/677 (0.00%)  0
Pruritus  1  7/691 (1.01%)  7 1/677 (0.15%)  1
Rash  1  9/691 (1.30%)  9 7/677 (1.03%)  8
Vascular disorders     
Hypertension  1  14/691 (2.03%)  16 12/677 (1.77%)  12
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: NCT01468987     History of Changes
Other Study ID Numbers: 12145
I2R-MC-BIAM ( Other Identifier: Eli Lilly and Company )
2011-001254-29 ( EudraCT Number )
First Submitted: November 8, 2011
First Posted: November 10, 2011
Results First Submitted: March 16, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018