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A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial With a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients With Type 2 Diabetes Mellitus Who Are Between 10 and Below 18 Years of Age

Trial Profile

A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial With a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients With Type 2 Diabetes Mellitus Who Are Between 10 and Below 18 Years of Age

Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Dec 2018

At a glance

  • Drugs Dapagliflozin (Primary) ; Saxagliptin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Sponsors AstraZeneca
  • Most Recent Events

    • 18 Dec 2018 Planned End Date changed from 20 Dec 2021 to 21 Nov 2022.
    • 06 Dec 2018 Planned End Date changed from 22 Sep 2021 to 20 Dec 2021.
    • 06 Dec 2018 Planned primary completion date changed from 21 Oct 2020 to 20 Dec 2021.
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