Trial Outcomes & Findings for A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes (NCT NCT02119819)
NCT ID: NCT02119819
Last Updated: 2021-05-27
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
420 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2021-05-27
Participant Flow
Participant milestones
| Measure |
10 mg LY2944876
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks, plus background PO metformin.
|
15 mg LY2944876
15 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
|
30 mg LY2944876
30 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
|
50 mg LY2944876
50 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
|
Exenatide Extended-release
2 mg exenatide extended-release given SC once weekly for 24 weeks, plus background PO metformin..
|
Placebo
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks,plus background PO metformin. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
71
|
73
|
70
|
69
|
71
|
|
Overall Study
COMPLETED
|
57
|
66
|
69
|
63
|
62
|
56
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
4
|
7
|
7
|
15
|
Reasons for withdrawal
| Measure |
10 mg LY2944876
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks, plus background PO metformin.
|
15 mg LY2944876
15 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
|
30 mg LY2944876
30 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
|
50 mg LY2944876
50 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
|
Exenatide Extended-release
2 mg exenatide extended-release given SC once weekly for 24 weeks, plus background PO metformin..
|
Placebo
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks,plus background PO metformin. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
2
|
3
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
2
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
0
|
0
|
6
|
10
|
|
Overall Study
Jury Duty
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Left the city to get a job
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=70 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
57.6 years
STANDARD_DEVIATION 9.1 • n=21 Participants
|
56.5 years
STANDARD_DEVIATION 9.7 • n=10 Participants
|
57.1 years
STANDARD_DEVIATION 8.9 • n=115 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
199 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
221 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
129 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
47 Participants
n=10 Participants
|
264 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
58 Participants
n=10 Participants
|
348 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
38 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
Greece
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
5 participants
n=21 Participants
|
6 participants
n=10 Participants
|
32 participants
n=115 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=10 Participants
|
12 participants
n=115 Participants
|
|
Region of Enrollment
Romania
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
10 participants
n=10 Participants
|
57 participants
n=115 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
33 participants
n=7 Participants
|
33 participants
n=5 Participants
|
34 participants
n=4 Participants
|
31 participants
n=21 Participants
|
30 participants
n=10 Participants
|
193 participants
n=115 Participants
|
|
Region of Enrollment
Poland
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
12 participants
n=21 Participants
|
11 participants
n=10 Participants
|
66 participants
n=115 Participants
|
|
Region of Enrollment
Mexico
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
9 participants
n=21 Participants
|
11 participants
n=10 Participants
|
60 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants with baseline and at least one post-baseline HbA1c data at Week 12. Missing observations are imputed using the Bayesian simple linear regression longitudinal model.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
10 mg LY2944876
n=57 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=68 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=68 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=65 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=63 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=62 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
|
-1.07 percentage of HbA1c
Standard Error 0.12
|
-1.09 percentage of HbA1c
Standard Error 0.11
|
-1.44 percentage of HbA1c
Standard Error 0.11
|
-1.33 percentage of HbA1c
Standard Error 0.11
|
-1.42 percentage of HbA1c
Standard Error 0.11
|
-0.29 percentage of HbA1c
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with baseline and at least one post-baseline HbA1c data at Week 24. Missing observations are imputed using the Bayesian simple linear regression longitudinal model.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
10 mg LY2944876
n=55 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=66 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=68 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=62 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=60 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=51 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c at Week 24
|
-0.85 percentage of HbA1c
Standard Error 0.14
|
-1.14 percentage of HbA1c
Standard Error 0.13
|
-1.37 percentage of HbA1c
Standard Error 0.13
|
-1.29 percentage of HbA1c
Standard Error 0.13
|
-1.48 percentage of HbA1c
Standard Error 0.13
|
-0.38 percentage of HbA1c
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 24Population: All randomized participants with baseline and at least one post-baseline data for body weight. Missing observations are imputed using the Bayesian simple linear regression longitudinal model.
Outcome measures
| Measure |
10 mg LY2944876
n=57 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=68 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=68 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=65 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=63 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=63 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight
Week 12
|
-1.09 Percentage change
Standard Error 0.35
|
-1.86 Percentage change
Standard Error 0.33
|
-2.01 Percentage change
Standard Error 0.33
|
-3.23 Percentage change
Standard Error 0.34
|
-2.04 Percentage change
Standard Error 0.35
|
-1.22 Percentage change
Standard Error 0.34
|
|
Percent Change From Baseline in Body Weight
Week 24
|
-1.57 Percentage change
Standard Error 0.47
|
-2.13 Percentage change
Standard Error 0.45
|
-1.98 Percentage change
Standard Error 0.45
|
-3.41 Percentage change
Standard Error 0.46
|
-2.18 Percentage change
Standard Error 0.47
|
-1.70 Percentage change
Standard Error 0.46
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 24Population: All randomized participants with baseline and at least one post-baseline data for fasting blood glucose. Missing observations are imputed using last observation carried forward (LOCF).
Least square means (LSM) was calculated from mixed-effects model with repeated measures (MMRM) analysis using restricted maximum likelihood (REML) with metformin use, baseline body mass index (BMI) category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=69 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose
Week 24
|
-21.497 milligrams per deciliter (mg/dL)
Standard Error 4.919
|
-30.186 milligrams per deciliter (mg/dL)
Standard Error 4.639
|
-29.875 milligrams per deciliter (mg/dL)
Standard Error 4.548
|
-31.390 milligrams per deciliter (mg/dL)
Standard Error 4.785
|
-40.328 milligrams per deciliter (mg/dL)
Standard Error 4.726
|
0.124 milligrams per deciliter (mg/dL)
Standard Error 4.973
|
|
Change From Baseline in Fasting Blood Glucose
Week 12
|
-20.881 milligrams per deciliter (mg/dL)
Standard Error 4.618
|
-21.991 milligrams per deciliter (mg/dL)
Standard Error 4.371
|
-31.309 milligrams per deciliter (mg/dL)
Standard Error 4.305
|
-28.405 milligrams per deciliter (mg/dL)
Standard Error 4.506
|
-39.074 milligrams per deciliter (mg/dL)
Standard Error 4.419
|
-1.588 milligrams per deciliter (mg/dL)
Standard Error 4.519
|
SECONDARY outcome
Timeframe: Baseline, Week (Wk) 12; Baseline, Week 24Population: All randomized participants with baseline and at least one post-baseline data for SMBG. Missing observations are imputed using last observation carried forward (LOCF).
SMBG 7-point profiles were measured at morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. LSM were calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=69 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Morning pre-meal (Week 12)
|
-26.8 mg/dL
Standard Error 3.9
|
-28.4 mg/dL
Standard Error 3.8
|
-34.3 mg/dL
Standard Error 3.7
|
-34.8 mg/dL
Standard Error 3.8
|
-38.7 mg/dL
Standard Error 3.8
|
-7.4 mg/dL
Standard Error 3.8
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Morning pre-meal (Week 24)
|
-23.5 mg/dL
Standard Error 4.7
|
-29.1 mg/dL
Standard Error 4.5
|
-29.6 mg/dL
Standard Error 4.3
|
-34.2 mg/dL
Standard Error 4.5
|
-36.8 mg/dL
Standard Error 4.5
|
-14.4 mg/dL
Standard Error 4.9
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Morning 2 hours post-meal (Week 12)
|
-27.9 mg/dL
Standard Error 6.7
|
-34.2 mg/dL
Standard Error 6.8
|
-36.0 mg/dL
Standard Error 6.3
|
-26.4 mg/dL
Standard Error 6.6
|
-43.5 mg/dL
Standard Error 6.5
|
-1.5 mg/dL
Standard Error 6.5
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Morning 2 hours post-meal (Week 24)
|
-29.9 mg/dL
Standard Error 6.5
|
-35.9 mg/dL
Standard Error 6.5
|
-37.1 mg/dL
Standard Error 6.1
|
-42.8 mg/dL
Standard Error 6.4
|
-42.7 mg/dL
Standard Error 6.4
|
-6.3 mg/dL
Standard Error 6.8
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Mid-day pre-meal (Week 12)
|
-17.1 mg/dL
Standard Error 5.1
|
-19.6 mg/dL
Standard Error 5.1
|
-26.1 mg/dL
Standard Error 4.8
|
-24.2 mg/dL
Standard Error 5.0
|
-23.5 mg/dL
Standard Error 5.0
|
-2.3 mg/dL
Standard Error 5.0
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Mid-day pre-meal (Week 24)
|
-16.3 mg/dL
Standard Error 5.6
|
-23.4 mg/dL
Standard Error 5.6
|
-22.4 mg/dL
Standard Error 5.3
|
-23.5 mg/dL
Standard Error 5.4
|
-23.9 mg/dL
Standard Error 5.5
|
-4.0 mg/dL
Standard Error 6.0
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Mid-day 2 hours post-meal (Week 12)
|
-17.1 mg/dL
Standard Error 6.4
|
-20.7 mg/dL
Standard Error 6.3
|
-24.6 mg/dL
Standard Error 6.0
|
-22.2 mg/dL
Standard Error 6.2
|
-27.4 mg/dL
Standard Error 6.2
|
-8.9 mg/dL
Standard Error 6.1
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Mid-day 2 hours post-meal (Week 24)
|
-12.2 mg/dL
Standard Error 6.1
|
-26.6 mg/dL
Standard Error 5.9
|
-21.9 mg/dL
Standard Error 5.7
|
-33.4 mg/dL
Standard Error 5.9
|
-37.2 mg/dL
Standard Error 5.9
|
-8.5 mg/dL
Standard Error 6.4
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Evening pre-meal (Week 12)
|
-24.1 mg/dL
Standard Error 5.3
|
-24.8 mg/dL
Standard Error 5.2
|
-28.5 mg/dL
Standard Error 4.9
|
-30.1 mg/dL
Standard Error 5.1
|
-24.7 mg/dL
Standard Error 5.1
|
-1.5 mg/dL
Standard Error 5.1
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Evening pre-meal (Week 24)
|
-24.9 mg/dL
Standard Error 5.7
|
-24.3 mg/dL
Standard Error 5.6
|
-33.0 mg/dL
Standard Error 5.3
|
-29.6 mg/dL
Standard Error 5.4
|
-36.4 mg/dL
Standard Error 5.6
|
-5.7 mg/dL
Standard Error 6.0
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Evening 2 hours post-meal (Week 12)
|
-25.1 mg/dL
Standard Error 5.9
|
-26.5 mg/dL
Standard Error 5.7
|
-33.4 mg/dL
Standard Error 5.4
|
-32.8 mg/dL
Standard Error 5.7
|
-33.5 mg/dL
Standard Error 5.7
|
4.0 mg/dL
Standard Error 5.6
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Evening 2 hours post-meal (Week 24)
|
-30.2 mg/dL
Standard Error 5.9
|
-27.9 mg/dL
Standard Error 5.8
|
-26.0 mg/dL
Standard Error 5.5
|
-37.2 mg/dL
Standard Error 5.8
|
-36.9 mg/dL
Standard Error 5.8
|
1.1 mg/dL
Standard Error 6.2
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Bedtime (Week 12)
|
-19.3 mg/dL
Standard Error 5.7
|
-33.5 mg/dL
Standard Error 5.8
|
-33.2 mg/dL
Standard Error 5.8
|
-36.2 mg/dL
Standard Error 5.6
|
-41.6 mg/dL
Standard Error 5.7
|
5.6 mg/dL
Standard Error 5.7
|
|
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Bedtime (Week 24)
|
-28.9 mg/dL
Standard Error 6.0
|
-25.4 mg/dL
Standard Error 6.0
|
-32.3 mg/dL
Standard Error 5.7
|
-38.5 mg/dL
Standard Error 5.9
|
-42.9 mg/dL
Standard Error 6.0
|
-6.9 mg/dL
Standard Error 6.4
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with baseline and at least one post-baseline data for lipids. Missing observations are imputed using last observation carried forward (LOCF).
Change from baseline in high-density lipoprotein cholesterol (HDL-C), total cholesterol, triglycerides, and low-density lipoprotein cholesterol (LDL-C). LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant an a random effect.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=69 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipids
HDL-C
|
1.56 mg/dL
Standard Error 1.03
|
0.92 mg/dL
Standard Error 0.98
|
0.90 mg/dL
Standard Error 0.96
|
1.04 mg/dL
Standard Error 1.01
|
2.35 mg/dL
Standard Error 0.990
|
2.17 mg/dL
Standard Error 1.04
|
|
Change From Baseline in Lipids
Total Cholesterol
|
-1.26 mg/dL
Standard Error 4.37
|
-1.12 mg/dL
Standard Error 4.16
|
-1.46 mg/dL
Standard Error 4.09
|
-5.11 mg/dL
Standard Error 4.24
|
-0.12 mg/dL
Standard Error 4.22
|
7.32 mg/dL
Standard Error 4.40
|
|
Change From Baseline in Lipids
Triglycerides
|
-14.63 mg/dL
Standard Error 11.49
|
-13.32 mg/dL
Standard Error 10.93
|
-15.40 mg/dL
Standard Error 10.59
|
-20.96 mg/dL
Standard Error 11.16
|
-11.83 mg/dL
Standard Error 11.01
|
10.61 mg/dL
Standard Error 11.58
|
|
Change From Baseline in Lipids
LDL-C
|
-1.37 mg/dL
Standard Error 3.75
|
-0.40 mg/dL
Standard Error 3.57
|
-0.24 mg/dL
Standard Error 3.56
|
-0.04 mg/dL
Standard Error 3.72
|
0.37 mg/dL
Standard Error 3.65
|
4.55 mg/dL
Standard Error 3.81
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 24Population: All randomized participants with baseline and at least one post-baseline data for fasting fibroblast growth factor 21. Missing observations are imputed using last observation carried forward (LOCF).
LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=69 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Fibroblast Growth Factor 21
Week 12
|
-0.07 microgram per liter (µg/L)
Standard Error 0.071
|
0.06 microgram per liter (µg/L)
Standard Error 0.068
|
-0.03 microgram per liter (µg/L)
Standard Error 0.068
|
-0.14 microgram per liter (µg/L)
Standard Error 0.069
|
-0.09 microgram per liter (µg/L)
Standard Error 0.069
|
-0.11 microgram per liter (µg/L)
Standard Error 0.071
|
|
Change From Baseline in Fasting Fibroblast Growth Factor 21
Week 24
|
0.06 microgram per liter (µg/L)
Standard Error 0.071
|
-0.04 microgram per liter (µg/L)
Standard Error 0.068
|
-0.07 microgram per liter (µg/L)
Standard Error 0.067
|
-0.12 microgram per liter (µg/L)
Standard Error 0.070
|
-0.06 microgram per liter (µg/L)
Standard Error 0.069
|
-0.09 microgram per liter (µg/L)
Standard Error 0.073
|
SECONDARY outcome
Timeframe: Baseline through Therapy Completion (Week 24)Population: All randomized participants with baseline and at least one post-baseline data for participants requiring rescue therapy.
Participants who received rescue medication with non-study antihyperglycemic medications or change their stable dose of metformin.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=69 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Requiring Rescue Therapy
|
6.1 percentage of participants
|
2.8 percentage of participants
|
2.7 percentage of participants
|
4.3 percentage of participants
|
2.9 percentage of participants
|
11.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: All randomized participants who received study drug and had evaluable immunogenicity.
Percentage of participants developing anti-drug antibodies to LY2944876.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=70 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Developing Anti-Drug Antibodies to LY2944876
Week 12
|
1.7 percentage of participants
|
1.4 percentage of participants
|
1.5 percentage of participants
|
0 percentage of participants
|
1.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Developing Anti-Drug Antibodies to LY2944876
Week 24
|
1.8 percentage of participants
|
0 percentage of participants
|
1.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 12, Week 16, Week 20, Week 24Population: All randomized participants who received study drug LY2944876 and had evaluable PK data.
Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=70 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876
|
607 nanogram per milliliter (ng/mL)
Standard Deviation 282
|
799 nanogram per milliliter (ng/mL)
Standard Deviation 368
|
1690 nanogram per milliliter (ng/mL)
Standard Deviation 732
|
2570 nanogram per milliliter (ng/mL)
Standard Deviation 1240
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 12, Week 16, Week 20, Week 24Population: All randomized participants who received study drug LY2944876 and had evaluable PK data.
Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=70 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876
|
88100 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 40600
|
117000 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 50800
|
247000 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 106000
|
381000 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 187000
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 24Population: All randomized participants with baseline and at least one post-baseline data for adiponectin levels. Missing observations are imputed using last observation carried forward (LOCF).
LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=69 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Adiponectin Levels
Week 12
|
0.14 µg/L
Standard Error 0.168
|
0.03 µg/L
Standard Error 0.160
|
-0.10 µg/L
Standard Error 0.157
|
0.12 µg/L
Standard Error 0.161
|
0.04 µg/L
Standard Error 0.160
|
0.03 µg/L
Standard Error 0.164
|
|
Change From Baseline in Adiponectin Levels
Week 24
|
0.03 µg/L
Standard Error 0.245
|
0.30 µg/L
Standard Error 0.226
|
0.28 µg/L
Standard Error 0.221
|
0.58 µg/L
Standard Error 0.235
|
0.14 µg/L
Standard Error 0.231
|
0.25 µg/L
Standard Error 0.250
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 24Population: All randomized participants with baseline and at least one post-baseline data for beta-hydroxy butyrate levels. Missing observations are imputed using last observation carried forward (LOCF).
LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=69 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Beta-Hydroxy Butyrate Levels
Week 12
|
-0.27 mg/dL
Standard Error 0.13
|
-0.28 mg/dL
Standard Error 0.12
|
-0.13 mg/dL
Standard Error 0.12
|
-0.31 mg/dL
Standard Error 0.12
|
-0.29 mg/dL
Standard Error 0.12
|
-0.23 mg/dL
Standard Error 0.13
|
|
Change From Baseline in Beta-Hydroxy Butyrate Levels
Week 24
|
-0.33 mg/dL
Standard Error 0.11
|
-0.39 mg/dL
Standard Error 0.10
|
-0.34 mg/dL
Standard Error 0.10
|
-0.33 mg/dL
Standard Error 0.10
|
-0.19 mg/dL
Standard Error 0.10
|
-0.37 mg/dL
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 24Population: All randomized participants with baseline and at least one post-baseline data for glucagon levels. Missing observations are imputed using last observation carried forward (LOCF).
LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=69 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Glucagon Levels
Week 12
|
-1.26 picomol per liter (pmol/L)
Standard Error 0.82
|
-2.65 picomol per liter (pmol/L)
Standard Error 0.79
|
-5.14 picomol per liter (pmol/L)
Standard Error 0.79
|
-6.21 picomol per liter (pmol/L)
Standard Error 0.81
|
-1.58 picomol per liter (pmol/L)
Standard Error 0.79
|
-0.04 picomol per liter (pmol/L)
Standard Error 0.84
|
|
Change From Baseline in Glucagon Levels
Week 24
|
-2.30 picomol per liter (pmol/L)
Standard Error 1.15
|
-2.25 picomol per liter (pmol/L)
Standard Error 1.05
|
-4.40 picomol per liter (pmol/L)
Standard Error 1.05
|
-4.93 picomol per liter (pmol/L)
Standard Error 1.11
|
-0.19 picomol per liter (pmol/L)
Standard Error 1.08
|
0.66 picomol per liter (pmol/L)
Standard Error 1.16
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 24Population: All randomized participants with baseline and at least one post-baseline data for insulin levels. Missing observations are imputed using last observation carried forward (LOCF).
LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.
Outcome measures
| Measure |
10 mg LY2944876
n=66 Participants
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 Participants
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 Participants
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=69 Participants
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 Participants
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 Participants
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Insulin Levels
Week 12
|
0.30 micro-international units/milliliter
Standard Error 1.21
|
0.97 micro-international units/milliliter
Standard Error 1.13
|
0.03 micro-international units/milliliter
Standard Error 1.14
|
0.96 micro-international units/milliliter
Standard Error 1.17
|
2.78 micro-international units/milliliter
Standard Error 1.14
|
-0.85 micro-international units/milliliter
Standard Error 1.16
|
|
Change From Baseline in Insulin Levels
Week 24
|
-1.44 micro-international units/milliliter
Standard Error 1.51
|
0.68 micro-international units/milliliter
Standard Error 1.39
|
0.58 micro-international units/milliliter
Standard Error 1.40
|
0.34 micro-international units/milliliter
Standard Error 1.48
|
1.97 micro-international units/milliliter
Standard Error 1.40
|
1.45 micro-international units/milliliter
Standard Error 1.51
|
Adverse Events
10 mg LY2944876
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
15 mg LY2944876
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
30 mg LY2944876
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
50 mg LY2944876
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Exenatide Extended-release
Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10 mg LY2944876
n=66 participants at risk
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 participants at risk
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 participants at risk
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=70 participants at risk
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 participants at risk
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 participants at risk
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/69 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Branchial cyst
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/69 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/69 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/69 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Vessel perforation
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
10 mg LY2944876
n=66 participants at risk
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
|
15 mg LY2944876
n=71 participants at risk
15 mg LY2944876 given SC once weekly for 24 weeks.
|
30 mg LY2944876
n=73 participants at risk
30 mg LY2944876 given SC once weekly for 24 weeks.
|
50 mg LY2944876
n=70 participants at risk
50 mg LY2944876 given SC once weekly for 24 weeks.
|
Exenatide Extended-release
n=69 participants at risk
2 mg exenatide extended-release given SC once weekly for 24 weeks.
|
Placebo
n=71 participants at risk
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
1/66 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
4.3%
3/70 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
5.8%
4/69 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
3/66 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
5.6%
4/71 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
5.5%
4/73 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
7.1%
5/70 • Number of events 8
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/69 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
7/66 • Number of events 35
All randomized participants who received at least 1 dose of study drug.
|
21.1%
15/71 • Number of events 24
All randomized participants who received at least 1 dose of study drug.
|
17.8%
13/73 • Number of events 45
All randomized participants who received at least 1 dose of study drug.
|
17.1%
12/70 • Number of events 25
All randomized participants who received at least 1 dose of study drug.
|
26.1%
18/69 • Number of events 52
All randomized participants who received at least 1 dose of study drug.
|
5.6%
4/71 • Number of events 16
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
7.1%
5/70 • Number of events 8
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/69 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
1.5%
1/66 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
5.5%
4/73 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/69 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
1/66 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
5.7%
4/70 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/69 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
11/66 • Number of events 28
All randomized participants who received at least 1 dose of study drug.
|
29.6%
21/71 • Number of events 33
All randomized participants who received at least 1 dose of study drug.
|
27.4%
20/73 • Number of events 53
All randomized participants who received at least 1 dose of study drug.
|
45.7%
32/70 • Number of events 90
All randomized participants who received at least 1 dose of study drug.
|
24.6%
17/69 • Number of events 55
All randomized participants who received at least 1 dose of study drug.
|
5.6%
4/71 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
8/66 • Number of events 9
All randomized participants who received at least 1 dose of study drug.
|
8.5%
6/71 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
13.7%
10/73 • Number of events 21
All randomized participants who received at least 1 dose of study drug.
|
31.4%
22/70 • Number of events 37
All randomized participants who received at least 1 dose of study drug.
|
8.7%
6/69 • Number of events 12
All randomized participants who received at least 1 dose of study drug.
|
2.8%
2/71 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
6.1%
4/66 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
4.1%
3/73 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
1.5%
1/66 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
5.6%
4/71 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/69 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.8%
2/71 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
12.1%
8/66 • Number of events 8
All randomized participants who received at least 1 dose of study drug.
|
12.7%
9/71 • Number of events 11
All randomized participants who received at least 1 dose of study drug.
|
6.8%
5/73 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
5.7%
4/70 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
8.7%
6/69 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
2.8%
2/71 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
1.5%
1/66 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
7.0%
5/71 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/70
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/69 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
2.8%
2/71 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
2/66 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
14.1%
10/71 • Number of events 12
All randomized participants who received at least 1 dose of study drug.
|
6.8%
5/73 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
4.3%
3/70 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
5.8%
4/69 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
5.5%
4/73 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
5.6%
4/71 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/70 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
6.1%
4/66 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
2.8%
2/71 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
2.7%
2/73 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
7.1%
5/70 • Number of events 9
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/69
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.5%
3/66 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
8.5%
6/71 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
8.2%
6/73 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
11.4%
8/70 • Number of events 9
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/69 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/66
All randomized participants who received at least 1 dose of study drug.
|
2.8%
2/71 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/73
All randomized participants who received at least 1 dose of study drug.
|
7.1%
5/70 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/69 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/71
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
4/66 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
8.5%
6/71 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/69 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
2.8%
2/71 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
6.1%
4/66 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
2.8%
2/71 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/69 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
7.6%
5/66 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
12.7%
9/71 • Number of events 13
All randomized participants who received at least 1 dose of study drug.
|
6.8%
5/73 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
8.6%
6/70 • Number of events 11
All randomized participants who received at least 1 dose of study drug.
|
13.0%
9/69 • Number of events 14
All randomized participants who received at least 1 dose of study drug.
|
5.6%
4/71 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.5%
3/66 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
4.2%
3/71 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/73 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/70 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
5.8%
4/69 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60