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A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Severe Renal Impairment Who Have Inadequate Glycemic Control

Trial Profile

A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Severe Renal Impairment Who Have Inadequate Glycemic Control

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jun 2022

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At a glance

  • Drugs Sotagliflozin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms SOTA-CKD4
  • Sponsors Lexicon Pharmaceuticals; Sanofi
  • Most Recent Events

    • 01 Dec 2021 Results published in the Diabetes, Obesity and Metabolism
    • 16 Jun 2020 Results presented at the 80th Annual Scientific Sessions of the American Diabetes Association
    • 13 Jun 2020 Results presented in the Lexicon Pharmaceuticals Media Release.
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