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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

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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: 03 Nov 2025

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At a glance

  • Drugs Sotagliflozin (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms European inTandem2; inTandem2
  • Sponsors Lexicon Pharmaceuticals

Most Recent Events

  • 22 Sep 2025 According to the Lexicon Pharmaceuticals Media Release, The company submitted additional information in response to the December 2024 Complete Response Letter to support the potential resubmission of the New Drug Application for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin for glycaemic control in adults with type 1 diabetes, and now seeks FDA alignment on a reasonable path forward, with feedback from the Type D meeting expected in the fourth quarter.
  • 06 Aug 2025 According to a Lexicon Pharmaceuticals media release, data from a study evaluating the impact of sotagliflozin on hypoglycemia in people with type 1 diabetes was delivered as an oral presentation during the 85th Scientific Sessions of the American Diabetes Association (ADA).
  • 20 Dec 2024 According to a Lexicon Pharmaceuticals media release, company announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).

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