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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 07 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top