NCT02383940

Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX4211 in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin	Sotagliflozin 400 mg, once daily before the first meal of the day
DRUG	Placebo	Placebo, once daily before the first meal of the day

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-03-10
• Last updated: 2020-02-12
• Results posted: 2019-10-30

Locations

15 sites across 1 country: United States