A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Triple Therapy With Saxagliptin Added to Dapagliflozin in Combination With Metformin Compared to Therapy With Placebo Added to Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Dapagliflozin
Phase of Trial: Phase III
Latest Information Update: 28 Feb 2017
At a glance
- Drugs Saxagliptin (Primary) ; Dapagliflozin; Metformin
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors AstraZeneca; Bristol-Myers Squibb
- 10 Jun 2017 Biomarkers information updated
- 28 Feb 2017 According to AstraZeneca media release, the US Food and Drug Administration (FDA) has approved once-daily Qtern for the treatment of type-2 diabetes based on data from this study.
- 19 Jul 2016 According to AstraZeneca media release, the European Commission (EC) has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway.