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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02338193 | Dapagliflozin and Metformin,Alone and in Combination, in Overweight/Obese Prior GDM Women | PHASE3 | COMPLETED | 69 | — | — | Sep 22, 2015 | Mar 13, 2019 | Jun 11, 2019 | 1 | United States |
Change in absolute body weight with combination therapy compared to monotherapy from baseline to week 24
| Arm | Type | Description |
|---|---|---|
| DAPA/MET Extended Release (XR) | EXPERIMENTAL | Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks |
| Dapaglifloxin | ACTIVE_COMPARATOR | Dapagliflozin- 10 mg once daily before first meal for 24 weeks |
| Metformin XR | ACTIVE_COMPARATOR | Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the morning (AM), 1000 mg in the evening ( PM) for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks |
| Name | Type | Description |
|---|---|---|
| DAPA/MET XR | DRUG | final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks |
| DAPA | DRUG | 10 mg dapagliflozin QD for 20-24 weeks |
| MET XR | DRUG | 1000 mg Metformin XR BID for 20-24 weeks |
Inclusion Criteria: * • Overweight/obese (BMI \>25) females 18 years to 45 years of age, who experienced gestational diabetes (GDM) during recent (within 12 months) pregnancy * postpartum metabolic abnormalities determined by a 75 g oral glucose tolerance test (Inclusive of prior GDM women with ...