drugset / Trial / NCT03608358
Safety and Efficacy of Dapagliflozin in Asian T2DM Subjects With Inadequate Glycemic Control on Metformin/Saxagliptin
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a 24-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, phase 3 study designed to evaluate if the safety and efficacy of dapagliflozin 5 mg or 10 mg added to saxagliptin 5 mg plus metformin is superior to placebo added to saxagliptin 5 mg plus metformin in reducing hemoglobin A1c (HbA1c).
Timeline
- Start
- 2019-02-27
- Primary completion
- 2020-08-04
- Completion
- 2020-08-04
Outcome
Outcome not reported
Stopped (Business): “Sponsor decided to stop commercialization of QTERNMet/Qtrilmet and to stop all related ongoing activities/studies for business reasons.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 5 mg | Oral |
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |
| Background | Metformin | Small molecule | — | — |
| Background | SAXAGLIPTIN ANHYDROUS | Small molecule | 5 mg | Oral |