NCT03386344

Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

A 26-week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study With a 78-week Extension Period to Evaluate the Efficacy and Bone Safety of Sotagliflozin in Patients 55 Years or Older With Type 2 Diabetes Mellitus and Inadequate Glycemic Control

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen.

Detailed description

Study duration per participant is approximately 110 weeks (Screening period of up to 2 weeks, 2 week single-blind run-in period), a 26-week double-blind core treatment period, a 78-week double-blind extension period, and a 2- week post treatment follow up period. Dual-energy X-ray absorptiometry (DXA) scans will be performed to assess Bone Mineral Density and Fat vs. Lean body mass at baseline and Weeks 26, 52, and 104.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin	Pharmaceutical form: Tablet; Route of administration: Oral
DRUG	Placebo	Pharmaceutical form: Tablet; Route of administration: Oral

Timeline

• Start date: 2018-02-19
• Primary completion: 2019-05-22
• Completion: 2020-05-30
• First posted: 2017-12-29
• Last updated: 2021-06-25
• Results posted: 2021-06-25

Locations

53 sites across 8 countries: United States, Australia, Canada, Mexico, New Zealand, Russia, South Korea, Taiwan

Regulatory

• FDA-regulated drug study