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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03235050 | A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes | PHASE2 | COMPLETED | 834 | — | — | Aug 2, 2017 | Jun 14, 2019 | Aug 17, 2020 | 119 | United States, Bulgaria +6 |
To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
| Arm | Type | Description |
|---|---|---|
| MEDI0382 low dose + Metformin | EXPERIMENTAL | Drug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) |
| MEDI0382 mid dose + Metformin | EXPERIMENTAL | Drug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) |
| MEDI0382 high dose + Metformin | EXPERIMENTAL | Drug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) |
| Placebo + Metformin | PLACEBO_COMPARATOR | Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) |
| Liraglutide + Metformin | ACTIVE_COMPARATOR | Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) |
| Name | Type | Description |
|---|---|---|
| MEDI0382 low dose | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| MEDI0382 mid dose | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| MEDI0382 high dose | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Placebo | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Liraglutide | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
Inclusion Criteria: * Provision of informed consent * Male and female subjects aged ≥ 18 years at screening * Body mass index ≥ 25 kg/m2 at screening * HbA1c range of 7.0% to 10.5% (inclusive) at screening * Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose of ≥...