CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Sotagliflozin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01742208
NCT01742208Phase 2Completed
CompareCT.gov

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

Lexicon Pharmaceuticals·interventional·Posted Dec 5, 2012·Updated Feb 12, 2020

In Brief

A Phase 2 clinical trial evaluating Sotagliflozin and Placebo for Type 1 Diabetes Mellitus. Completed, enrolled 36 participants across 7 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2012
Enrollment StartFeb 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.6 years ago

Interventions

Sotagliflozindrug

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.

Placebodrug

Participants received placebo-matching sotagliflozin tablets once daily for 29 days.

Sotagliflozindrug

Participants received sotagliflozin once daily for 29 days; pioneer participants completed dosing prior to dosing any other study participants.