← Trials/Trial dossier/NCT02119819
A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes
Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes
Lead sponsor
Asset
Exenatide
Subcutaneous · GLP-1 agonist
Listed sites
51
Recruiting sites
—
Enrollment
420
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI 23-45•HbA1c 7-10.5%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (15)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointPercent Change From Baseline in Body Weight
Time frame:Baseline, Week 12; Baseline, Week 24
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percentage change | 95% CI |
|---|---|---|
| 10 mg LY2944876Week 12 | -1.09 | — |
| Week 24 | -1.57 | — |
| 15 mg LY2944876Week 12 | -1.86 | — |
| Week 24 | -2.13 | — |
| 30 mg LY2944876Week 12 | -2.01 | — |
| Week 24 | -1.98 | — |
| 50 mg LY2944876Week 12 | -3.23 | — |
| Week 24 | -3.41 | — |
| Exenatide Extended-releaseWeek 12 | -2.04 | — |
| Week 24 | -2.18 | — |
| PlaceboWeek 12 | -1.22 | — |
| Week 24 | -1.70 | — |
Glycemic / diabetes
7 endpointsChange From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Time frame:Baseline, Week 12
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), percentage of HbA1c | 95% CI |
|---|---|---|
| 10 mg LY2944876 | -1.07 | — |
| 15 mg LY2944876 | -1.09 | — |
| 30 mg LY2944876 | -1.44 | — |
| 50 mg LY2944876 | -1.33 | — |
| Exenatide Extended-release | -1.42 | — |
| Placebo | -0.29 | — |
Change From Baseline in HbA1c at Week 24
Time frame:Baseline, Week 24
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), percentage of HbA1c | 95% CI |
|---|---|---|
| 10 mg LY2944876 | -0.85 | — |
| 15 mg LY2944876 | -1.14 | — |
| 30 mg LY2944876 | -1.37 | — |
| 50 mg LY2944876 | -1.29 | — |
| Exenatide Extended-release | -1.48 | — |
| Placebo | -0.38 | — |
Change From Baseline in Fasting Blood Glucose
Time frame:Baseline, Week 12; Baseline, Week 24
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (least_squares_mean), milligrams per deciliter (mg/dL) | 95% CI |
|---|---|---|
| 10 mg LY2944876Week 12 | -20.881 | — |
| Week 24 | -21.497 | — |
| 15 mg LY2944876Week 12 | -21.991 | — |
| Week 24 | -30.186 | — |
| 30 mg LY2944876Week 12 | -31.309 | — |
| Week 24 | -29.875 | — |
| 50 mg LY2944876Week 12 | -28.405 | — |
| Week 24 | -31.390 | — |
| Exenatide Extended-releaseWeek 12 | -39.074 | — |
| Week 24 | -40.328 | — |
| PlaceboWeek 12 | -1.588 | — |
| Week 24 | 0.124 | — |
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Time frame:Baseline, Week (Wk) 12; Baseline, Week 24
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), mg/dL | 95% CI |
|---|---|---|
| 10 mg LY2944876Morning pre-meal (Week 12) | -26.8 | — |
| Morning pre-meal (Week 24) | -23.5 | — |
| Morning 2 hours post-meal (Week 12) | -27.9 | — |
| Morning 2 hours post-meal (Week 24) | -29.9 | — |
| Mid-day pre-meal (Week 12) | -17.1 | — |
| Mid-day pre-meal (Week 24) | -16.3 | — |
| Mid-day 2 hours post-meal (Week 12) | -17.1 | — |
| Mid-day 2 hours post-meal (Week 24) | -12.2 | — |
| Evening pre-meal (Week 12) | -24.1 | — |
| Evening pre-meal (Week 24) | -24.9 | — |
| Evening 2 hours post-meal (Week 12) | -25.1 | — |
| Evening 2 hours post-meal (Week 24) | -30.2 | — |
| Bedtime (Week 12) | -19.3 | — |
| Bedtime (Week 24) | -28.9 | — |
| 15 mg LY2944876Morning pre-meal (Week 12) | -28.4 | — |
| Morning pre-meal (Week 24) | -29.1 | — |
| Morning 2 hours post-meal (Week 12) | -34.2 | — |
| Morning 2 hours post-meal (Week 24) | -35.9 | — |
| Mid-day pre-meal (Week 12) | -19.6 | — |
| Mid-day pre-meal (Week 24) | -23.4 | — |
| Mid-day 2 hours post-meal (Week 12) | -20.7 | — |
| Mid-day 2 hours post-meal (Week 24) | -26.6 | — |
| Evening pre-meal (Week 12) | -24.8 | — |
| Evening pre-meal (Week 24) | -24.3 | — |
| Evening 2 hours post-meal (Week 12) | -26.5 | — |
| Evening 2 hours post-meal (Week 24) | -27.9 | — |
| Bedtime (Week 12) | -33.5 | — |
| Bedtime (Week 24) | -25.4 | — |
| 30 mg LY2944876Morning pre-meal (Week 12) | -34.3 | — |
| Morning pre-meal (Week 24) | -29.6 | — |
| Morning 2 hours post-meal (Week 12) | -36.0 | — |
| Morning 2 hours post-meal (Week 24) | -37.1 | — |
| Mid-day pre-meal (Week 12) | -26.1 | — |
| Mid-day pre-meal (Week 24) | -22.4 | — |
| Mid-day 2 hours post-meal (Week 12) | -24.6 | — |
| Mid-day 2 hours post-meal (Week 24) | -21.9 | — |
| Evening pre-meal (Week 12) | -28.5 | — |
| Evening pre-meal (Week 24) | -33.0 | — |
| Evening 2 hours post-meal (Week 12) | -33.4 | — |
| Evening 2 hours post-meal (Week 24) | -26.0 | — |
| Bedtime (Week 12) | -33.2 | — |
| Bedtime (Week 24) | -32.3 | — |
| 50 mg LY2944876Morning pre-meal (Week 12) | -34.8 | — |
| Morning pre-meal (Week 24) | -34.2 | — |
| Morning 2 hours post-meal (Week 12) | -26.4 | — |
| Morning 2 hours post-meal (Week 24) | -42.8 | — |
| Mid-day pre-meal (Week 12) | -24.2 | — |
| Mid-day pre-meal (Week 24) | -23.5 | — |
| Mid-day 2 hours post-meal (Week 12) | -22.2 | — |
| Mid-day 2 hours post-meal (Week 24) | -33.4 | — |
| Evening pre-meal (Week 12) | -30.1 | — |
| Evening pre-meal (Week 24) | -29.6 | — |
| Evening 2 hours post-meal (Week 12) | -32.8 | — |
| Evening 2 hours post-meal (Week 24) | -37.2 | — |
| Bedtime (Week 12) | -36.2 | — |
| Bedtime (Week 24) | -38.5 | — |
| Exenatide Extended-releaseMorning pre-meal (Week 12) | -38.7 | — |
| Morning pre-meal (Week 24) | -36.8 | — |
| Morning 2 hours post-meal (Week 12) | -43.5 | — |
| Morning 2 hours post-meal (Week 24) | -42.7 | — |
| Mid-day pre-meal (Week 12) | -23.5 | — |
| Mid-day pre-meal (Week 24) | -23.9 | — |
| Mid-day 2 hours post-meal (Week 12) | -27.4 | — |
| Mid-day 2 hours post-meal (Week 24) | -37.2 | — |
| Evening pre-meal (Week 12) | -24.7 | — |
| Evening pre-meal (Week 24) | -36.4 | — |
| Evening 2 hours post-meal (Week 12) | -33.5 | — |
| Evening 2 hours post-meal (Week 24) | -36.9 | — |
| Bedtime (Week 12) | -41.6 | — |
| Bedtime (Week 24) | -42.9 | — |
| PlaceboMorning pre-meal (Week 12) | -7.4 | — |
| Morning pre-meal (Week 24) | -14.4 | — |
| Morning 2 hours post-meal (Week 12) | -1.5 | — |
| Morning 2 hours post-meal (Week 24) | -6.3 | — |
| Mid-day pre-meal (Week 12) | -2.3 | — |
| Mid-day pre-meal (Week 24) | -4.0 | — |
| Mid-day 2 hours post-meal (Week 12) | -8.9 | — |
| Mid-day 2 hours post-meal (Week 24) | -8.5 | — |
| Evening pre-meal (Week 12) | -1.5 | — |
| Evening pre-meal (Week 24) | -5.7 | — |
| Evening 2 hours post-meal (Week 12) | 4.0 | — |
| Evening 2 hours post-meal (Week 24) | 1.1 | — |
| Bedtime (Week 12) | 5.6 | — |
| Bedtime (Week 24) | -6.9 | — |
Percentage of Participants Requiring Rescue Therapy
Time frame:Baseline through Therapy Completion (Week 24)
threshold achievement, event
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| 10 mg LY2944876 | 6.1 | — |
| 15 mg LY2944876 | 2.8 | — |
| 30 mg LY2944876 | 2.7 | — |
| 50 mg LY2944876 | 4.3 | — |
| Exenatide Extended-release | 2.9 | — |
| Placebo | 11.3 | — |
Change From Baseline in Glucagon Levels
Time frame:Baseline, Week 12; Baseline, Week 24
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), picomol per liter (pmol/L) | 95% CI |
|---|---|---|
| 10 mg LY2944876Week 12 | -1.26 | — |
| Week 24 | -2.30 | — |
| 15 mg LY2944876Week 12 | -2.65 | — |
| Week 24 | -2.25 | — |
| 30 mg LY2944876Week 12 | -5.14 | — |
| Week 24 | -4.40 | — |
| 50 mg LY2944876Week 12 | -6.21 | — |
| Week 24 | -4.93 | — |
| Exenatide Extended-releaseWeek 12 | -1.58 | — |
| Week 24 | -0.19 | — |
| PlaceboWeek 12 | -0.04 | — |
| Week 24 | 0.66 | — |
Change From Baseline in Insulin Levels
Time frame:Baseline, Week 12; Baseline, Week 24
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), micro-international units/milliliter | 95% CI |
|---|---|---|
| 10 mg LY2944876Week 12 | 0.30 | — |
| Week 24 | -1.44 | — |
| 15 mg LY2944876Week 12 | 0.97 | — |
| Week 24 | 0.68 | — |
| 30 mg LY2944876Week 12 | 0.03 | — |
| Week 24 | 0.58 | — |
| 50 mg LY2944876Week 12 | 0.96 | — |
| Week 24 | 0.34 | — |
| Exenatide Extended-releaseWeek 12 | 2.78 | — |
| Week 24 | 1.97 | — |
| PlaceboWeek 12 | -0.85 | — |
| Week 24 | 1.45 | — |
Cardiometabolic biomarkers
3 endpointsChange From Baseline in Lipids
Time frame:Baseline, Week 24
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), mg/dL | 95% CI |
|---|---|---|
| 10 mg LY2944876HDL-C | 1.56 | — |
| Total Cholesterol | -1.26 | — |
| Triglycerides | -14.63 | — |
| LDL-C | -1.37 | — |
| 15 mg LY2944876HDL-C | 0.92 | — |
| Total Cholesterol | -1.12 | — |
| Triglycerides | -13.32 | — |
| LDL-C | -0.40 | — |
| 30 mg LY2944876HDL-C | 0.90 | — |
| Total Cholesterol | -1.46 | — |
| Triglycerides | -15.40 | — |
| LDL-C | -0.24 | — |
| 50 mg LY2944876HDL-C | 1.04 | — |
| Total Cholesterol | -5.11 | — |
| Triglycerides | -20.96 | — |
| LDL-C | -0.04 | — |
| Exenatide Extended-releaseHDL-C | 2.35 | — |
| Total Cholesterol | -0.12 | — |
| Triglycerides | -11.83 | — |
| LDL-C | 0.37 | — |
| PlaceboHDL-C | 2.17 | — |
| Total Cholesterol | 7.32 | — |
| Triglycerides | 10.61 | — |
| LDL-C | 4.55 | — |
Change From Baseline in Fasting Fibroblast Growth Factor 21
Time frame:Baseline, Week 12; Baseline, Week 24
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), microgram per liter (µg/L) | 95% CI |
|---|---|---|
| 10 mg LY2944876Week 12 | -0.07 | — |
| Week 24 | 0.06 | — |
| 15 mg LY2944876Week 12 | 0.06 | — |
| Week 24 | -0.04 | — |
| 30 mg LY2944876Week 12 | -0.03 | — |
| Week 24 | -0.07 | — |
| 50 mg LY2944876Week 12 | -0.14 | — |
| Week 24 | -0.12 | — |
| Exenatide Extended-releaseWeek 12 | -0.09 | — |
| Week 24 | -0.06 | — |
| PlaceboWeek 12 | -0.11 | — |
| Week 24 | -0.09 | — |
Change From Baseline in Adiponectin Levels
Time frame:Baseline, Week 12; Baseline, Week 24
Adiponectin, change
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), µg/L | 95% CI |
|---|---|---|
| 10 mg LY2944876Week 12 | 0.14 | — |
| Week 24 | 0.03 | — |
| 15 mg LY2944876Week 12 | 0.03 | — |
| Week 24 | 0.30 | — |
| 30 mg LY2944876Week 12 | -0.10 | — |
| Week 24 | 0.28 | — |
| 50 mg LY2944876Week 12 | 0.12 | — |
| Week 24 | 0.58 | — |
| Exenatide Extended-releaseWeek 12 | 0.04 | — |
| Week 24 | 0.14 | — |
| PlaceboWeek 12 | 0.03 | — |
| Week 24 | 0.25 | — |
Safety / tolerability / PK
3 endpointsPercentage of Participants Developing Anti-Drug Antibodies to LY2944876
Time frame:Week 12 and Week 24
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| 10 mg LY2944876Week 12 | 1.7 | — |
| Week 24 | 1.8 | — |
| 15 mg LY2944876Week 12 | 1.4 | — |
| Week 24 | 0 | — |
| 30 mg LY2944876Week 12 | 1.5 | — |
| Week 24 | 1.5 | — |
| 50 mg LY2944876Week 12 | 0 | — |
| Week 24 | 0 | — |
| Exenatide Extended-releaseWeek 12 | 1.6 | — |
| Week 24 | 0 | — |
| PlaceboWeek 12 | 0 | — |
| Week 24 | 0 | — |
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876
Time frame:Baseline, Week 8, Week 12, Week 16, Week 20, Week 24
Cmax
concentration, descriptive
Posted result
| Group | Value (mean), nanogram per milliliter (ng/mL) | 95% CI |
|---|---|---|
| 10 mg LY2944876 | 607 | — |
| 15 mg LY2944876 | 799 | — |
| 30 mg LY2944876 | 1690 | — |
| 50 mg LY2944876 | 2570 | — |
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876
Time frame:Baseline, Week 8, Week 12, Week 16, Week 20, Week 24
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (mean), nanograms*hour per milliliter (ng*h/mL) | 95% CI |
|---|---|---|
| 10 mg LY2944876 | 88100 | — |
| 15 mg LY2944876 | 117000 | — |
| 30 mg LY2944876 | 247000 | — |
| 50 mg LY2944876 | 381000 | — |
Other (unclassified)
1 endpointChange From Baseline in Beta-Hydroxy Butyrate Levels
Time frame:Baseline, Week 12; Baseline, Week 24
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), mg/dL | 95% CI |
|---|---|---|
| 10 mg LY2944876Week 12 | -0.27 | — |
| Week 24 | -0.33 | — |
| 15 mg LY2944876Week 12 | -0.28 | — |
| Week 24 | -0.39 | — |
| 30 mg LY2944876Week 12 | -0.13 | — |
| Week 24 | -0.34 | — |
| 50 mg LY2944876Week 12 | -0.31 | — |
| Week 24 | -0.33 | — |
| Exenatide Extended-releaseWeek 12 | -0.29 | — |
| Week 24 | -0.19 | — |
| PlaceboWeek 12 | -0.23 | — |
| Week 24 | -0.37 | — |
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Expert opinion on emerging drugs2019 Jun (month)PMID30957581doi:10.1080/14728214.2019.1604684via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.