Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DAPA/MET · 1 trial · 1 indication
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 ...
DAPA/MET is being studied for diabetes prevention in women who have had gestational diabetes mellitus (GDM) and are at high risk of developing type 2 diabetes. It combines dapagliflozin and metformin, given alone and together, in overweight or obese women with a prior history of GDM.
DAPA/MET is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 3 trial evaluating dapagliflozin and metformin, alone and in combination, in this patient population.
DAPA/MET is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The completed study enrolled 69 participants and was conducted in the United States.
DAPA/MET has been evaluated in one completed Phase 3 trial, NCT02338193, titled "Dapagliflozin and Metformin, Alone and in Combination, in Overweight/Obese Prior GDM Women." The trial enrolled 69 female participants aged 18 years and older and was active-controlled.