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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Mar 2024

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At a glance

  • Drugs Sotagliflozin (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms inTandem1
  • Sponsors Lexicon Pharmaceuticals
  • Most Recent Events

    • 11 Mar 2024 According to a Lexicon Pharmaceuticals media release, following recent feedback from FDA, preparations are underway to resubmit Lexicons NDA for sotagliflozin as an adjunct to insulin therapy in patients with type 1 diabetes.
    • 14 Sep 2020 Results of pooled analysis of two studies (inTandem 1 & inTandem 2) assessing incidence and risk factors for diabetic ketoacidosis and related adverse events in adults with type 1 diabetes treated with sotagliflozin adjunctive to insulin, published in the Diabetes Care.
    • 16 Jun 2020 Results of pooled analysis of data from the two, 52 weeks, placebo controlled studies assessing the incidents of severe hypoglycemia, presented at the 80th Annual Scientific Sessions of the American Diabetes Association
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