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Exantide with Dapagliflozin · 1 trial · 1 indication
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...
Exantide with Dapagliflozin is used for the treatment of Diabetes Mellitus. It is a combination therapy being developed by AstraZeneca PLC for patients with this metabolic condition. The drug is currently in Phase 3 clinical development.
The specific molecular target of Exantide with Dapagliflozin is not disclosed in the available information. The drug is a small molecule combination therapy being studied for its efficacy and safety in patients with Diabetes Mellitus.
Exantide with Dapagliflozin is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate this combination therapy for Diabetes Mellitus.
Exantide with Dapagliflozin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform potential regulatory submissions.
Exantide with Dapagliflozin has one completed Phase 3 clinical trial, identified as NCT02229396. This was a 28-week study with 24-week and 52-week extension phases, evaluating the efficacy and safety of exenatide once weekly and dapagliflozin versus exenatide and dapagliflozin matching placebo in 695 participants with Diabetes Mellitus.
Exantide with Dapagliflozin is a combination of exenatide and dapagliflozin. The clinical trial NCT02229396 evaluated this combination against exenatide with a dapagliflozin matching placebo, indicating that the drug combines these two active ingredients for the treatment of Diabetes Mellitus.