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An 18-week, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in combination with Metformin in Comparison with Sitagliptin in combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy alone

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An 18-week, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in combination with Metformin in Comparison with Sitagliptin in combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy alone

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2021

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At a glance

  • Drugs Saxagliptin (Primary) ; Metformin; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Sponsors AstraZeneca

    • Most Recent Events

    • 31 Mar 2012 Planned number of patients changed from 210 to 1900 as reported by European Clinical Trials Database.
    • 16 Apr 2010 Actual patient number changed from 801 to 822 as reported by ClinicalTrials.gov.
    • 05 Oct 2009 Primary endpoint 'Proportion of glycosylated haemoglobin' has been met, as reported in a Bristol-Myers Squibb media release.

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