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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Nov 2024

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At a glance

  • Drugs Dapagliflozin (Primary) ; Saxagliptin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms T2NOW
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 12 Jun 2024 According to an AstraZeneca media release, FARXIGA (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older.
  • 20 Mar 2024 Status changed from active, no longer recruiting to completed.
  • 15 Dec 2023 This trial has been completed in Poland.

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