NCT03242018

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

A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Severe Renal Impairment Who Have Inadequate Glycemic Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment and a visit 4 weeks after completion of the randomized treatment period.

Conditions

• Type 2 Diabetes Mellitus
• Chronic Kidney Disease Stage 4

Interventions

Type	Name	Description
DRUG	Placebo	Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.
DRUG	Sotagliflozin	Sotagliflozin 200 mg, tablet, orally, once daily.

Timeline

• Start date: 2017-08-16
• Primary completion: 2019-05-16
• Completion: 2019-12-11
• First posted: 2017-08-08
• Last updated: 2021-06-25
• Results posted: 2021-06-25

Locations

106 sites across 15 countries: United States, Argentina, Brazil, Colombia, Germany, Hungary, Israel, Italy, Mexico, Poland, Romania, Russia, South Africa, Spain, Ukraine

Regulatory

• FDA-regulated drug study