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A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin

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Trial Profile

A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Dapagliflozin (Primary) ; Exenatide (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms DURATION-8
  • Sponsors AstraZeneca; AstraZeneca AB

    • Most Recent Events

    • 14 Apr 2021 Results (n=1042) of systematic review and meta-analysis of pooled data from randomized controlled trials (AWARD-10, DURATION-8 and SUSTAIN 9 trials) assessing the safety and efficacy of addition of a glucagon-like peptide-1 receptor agonists (GLP-1RAs) on a Sodium-glucose co-transporter-2 inhibitors (SGLT-2i) compared to SGLT-2i alone in patients with type 2 diabetes mellitus, presented at the Joint Meeting of the European Society of Hypertension and International Society of Hypertension.
    • 18 Aug 2020 Results (n=431) assessing efficacy and safety at 104 weeks, published in the Diabetes Care.
    • 05 Oct 2018 Results assessing the efficacy and safety of exenatide once weekly across 10 comparator-controlled studies from the DURATION clinical programme (n=2251) presented at the 54th Annual Meeting of the European Association for the Study of Diabetes
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