NCT01742208

Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of LX4211 in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin	Participants received sotagliflozin once daily for 29 days. Pioneer Group participants were to have completed dosing prior to any study drug administration in Expansion Groups.
DRUG	Placebo	Participants received placebo-matching sotagliflozin tablets once daily for 29 days.
DRUG	Sotagliflozin	Participants received sotagliflozin once daily for 29 days; pioneer participants completed dosing prior to dosing any other study participants.

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-12-05
• Last updated: 2020-02-12
• Results posted: 2019-10-30

Locations

7 sites across 1 country: United States