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A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Empagliflozin, and Placebo in Participants With Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin

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Trial Profile

A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Empagliflozin, and Placebo in Participants With Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Aug 2024

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At a glance

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

    • Most Recent Events

    • 20 Dec 2019 According to Lexicon pharmaceutical media release,topline data from the remainder of the core Phase 3 sotagliflozin studies in type 2 diabetes is expected in early 2020.
    • 20 Dec 2019 Primary endpoint has been met. (Change in HbA1c)
    • 20 Dec 2019 According to Lexicon pharmaceutical media release, full results of SOTA-EMPA, will be presented at future medical conferences.

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