Trial Profile
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 16 Mar 2024
Price :
$35
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At a glance
- Drugs Sotagliflozin (Primary)
- Indications Type 1 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms inTandem3
- Sponsors Lexicon Pharmaceuticals
- 12 Mar 2024 According to a Lexicon Pharmaceuticals media release, the efficacy and safety data from this trial were presented last week at ATTD 2024-17th International Conference on Advanced Technologies and Treatments for Diabetes in Florence, Italy.
- 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.
- 06 Oct 2023 Results of post hoc analysis assessing clinical factors associated with changes in beta hydroxybutyrate with sotagliflozin in adults with type 1 diabetes , presented at the 59th Annual Meeting of the European Association for the Study of Diabetes