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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Sotagliflozin (Primary) ; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms SOTA-MET
  • Sponsors Lexicon Pharmaceuticals; Sanofi

    • Most Recent Events

    • 13 Mar 2020 Planned number of patients changed from 500 to 1000.
    • 26 Jul 2019 According to a Lexicon Pharmaceuticals media release, primary endpoint (Change from Baseline in HbA1c) has been met.
    • 26 Jul 2019 According to a Lexicon Pharmaceuticals media release, data will be presented at upcoming medical conferences.

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