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A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

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Trial Profile

A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2022

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At a glance

  • Drugs Exenatide (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Amylin Pharmaceuticals; AstraZeneca

    • Most Recent Events

    • 23 Jul 2021 According to an AstraZeneca media release, based on the data from this trial, BYDUREON BCise (exenatide extended-release), once-weekly injectable suspension has been approved in the US for the treatment of type 2 diabetes (T2D); to improve glycemic control in pediatric patients (10 to 17 years) as an adjunct to diet and exercise.
    • 25 Jun 2021 According to an AstraZeneca media release, William Tamborlane, MD, Department of Pediatrics, Yale School of Medicine, is a International Coordinating Investigator of the trial.
    • 25 Jun 2021 Primary endpoint has been met. (Assess effect of EQW on glycemic control), according to an AstraZeneca media release.

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