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 used for diabetes prevention in women after gestational diabetes mellitus (GDM) who are at high risk. It is being studied in overweight or obese women with a history of GDM to prevent the onset of type 2 diabetes. The drug is a combination of dapagliflozin and metformin.
DAPA/MET 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 the drug's safety and efficacy in preventing diabetes in high-risk women with a history of gestational diabetes.
DAPA/MET is in Phase 3 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is currently being evaluated in a completed Phase 3 trial for diabetes prevention in women after gestational diabetes who are at high risk.
DAPA/MET is being studied in a Phase 3 clinical trial with the identifier NCT02338193. The trial, titled 'Dapagliflozin and Metformin, Alone and in Combination, in Overweight/Obese Prior GDM Women,' has been completed. It enrolled 69 participants in the United States, all female, aged 18 years and older.
DAPA/MET combines dapagliflozin and metformin. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that reduces glucose reabsorption in the kidneys, increasing glucose excretion. Metformin decreases hepatic glucose production and improves insulin sensitivity. Together, they target multiple pathways to lower blood glucose and potentially prevent diabetes.
DAPA/MET is a combination of dapagliflozin and metformin, two established diabetes medications. The drug name reflects this combination. In clinical trials, it is being studied alone and in combination to assess its effectiveness in preventing diabetes in high-risk women with a history of gestational diabetes.