drugset / Trial / NCT02284893
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
RandomizedParallel-groupTriple-blindTreatment
Summary
Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.
Timeline
- Start
- 2014-09-09
- Primary completion
- 2016-09-20
- Completion
- 2016-09-20
Outcome
Met primary endpoint
registry analysis (superiority test); Saxagliptin + Dapagliflozin + Metformin Group vs SITA + MET; p = 0.0008; Mean Difference (Final Values) -0.34; Mixed Models Analysis NCT02284893 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |
| Subject | SAXAGLIPTIN ANHYDROUS | Small molecule | 5 mg | Oral |
| Subject | Sitagliptin | Small molecule | 100 mg | Oral |