Overview

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

Status:
Completed

Trial end date:
2019-12-11

Target enrollment:

Participant gender:

Summary

Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: - To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c - To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo - To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

Phase:

Phase 3

Details

Lead Sponsor:

Lexicon Pharmaceuticals
Sanofi

Collaborator:

Sanofi

Treatments:

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol