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A 52-week Randomized, Double-blind, Double-dummy, Active and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Glimepiride or Placebo Added to Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin Monotherapy

Trial Profile

A 52-week Randomized, Double-blind, Double-dummy, Active and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Glimepiride or Placebo Added to Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin Monotherapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Dec 2021

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At a glance

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

    • 21 Jul 2020 Primary endpoint (Change in hemoglobin A1c (for sotagliflozin dose1)) has been met, according to a Lexicon Pharmaceuticals Media Release
    • 21 Jul 2020 According to a Lexicon Pharmaceuticals Media Release, final results from this study will be preserved for upcoming medical congresses and publications.
    • 21 Jul 2020 Results presented in the Lexicon Pharmaceuticals Media Release.
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