Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02119819 | A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes | PHASE2 | COMPLETED | 420 | — | — | Apr 1, 2014 | Oct 1, 2015 | May 27, 2021 | 51 | United States, Greece +4 |
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
| Arm | Type | Description |
|---|---|---|
| 10 mg LY2944876 | EXPERIMENTAL | 10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. |
| 15 mg LY2944876 | EXPERIMENTAL | 15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. |
| 30 mg LY2944876 | EXPERIMENTAL | 30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. |
| 50 mg LY2944876 | EXPERIMENTAL | 50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. |
| Exenatide extended-release | EXPERIMENTAL | 2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. |
| Placebo | PLACEBO_COMPARATOR | 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. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. |
| Name | Type | Description |
|---|---|---|
| LY2944876 | DRUG | Administered SC |
| Exenatide extended-release | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Metformin | DRUG | Oral |
Inclusion Criteria: * Men or women with diabetes mellitus Type 2 * Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening * Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screenin...