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

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Type 1 Diabetes Mellitus
Interventions
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.

Trial Locations (7)

10467

Lexicon Investigational Site, The Bronx

27713

Lexicon Investigational Site, Durham

30318

Lexicon Investigational Site, Atlanta

68131

Lexicon Investigational Site, Omaha

70808

Lexicon Investigational Site, Baton Rouge

75230

Lexicon Investigational Site, Dallas

80045

Lexicon Investigational Site, Aurora

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY