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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02229396 | Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo | PHASE3 | COMPLETED | 695 | — | — | Sep 4, 2014 | Dec 28, 2017 | Dec 31, 2018 | 133 | United States, Hungary +4 |
To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
| Arm | Type | Description |
|---|---|---|
| Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg | EXPERIMENTAL | - |
| Exenatide Once Weekly 2 mg Alone | EXPERIMENTAL | - |
| Dapagliflozin Once Daily 10 mg Alone | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Exantide with Dapagliflozin | DRUG | 2 mg weekly suspension injection and 10 mg Dapagliflozin |
| Exentide | DRUG | 2 mg |
| Dapagliflozin | DRUG | 10 mg once daily Dapagliflozin |
Inclusion criteria * Has a diagnosis of T2DM. * Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2. * Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening. Exclusion criteria * FPG ≥280 mg/dL (15.6 mmol/L). * Serum calcitonin concentration ≥40 p...