NCT03285594

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 571 (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 in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs). Secondary Objectives: * To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c. * To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP. * To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.

Detailed description

Up to 60 weeks (Screening phase of up to 2 weeks, a 4-week Lantus titration/single-blind placebo Run-in phase), a 52-week double blind Treatment Period, and a 2-week post-treatment Follow-up Period.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Insulin glargine (HOE901)	Pharmaceutical form: Solution Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Oral Antidiabetes Drugs (OADs)	OADs (including metformin) as prescribed by the investigator as per local labeling.

Timeline

• Start date: 2017-09-15
• Primary completion: 2019-09-17
• Completion: 2019-09-27
• First posted: 2017-09-18
• Last updated: 2021-05-11
• Results posted: 2021-05-11

Locations

106 sites across 8 countries: United States, Bulgaria, Canada, Czechia, France, Hungary, Slovakia, United Kingdom

Regulatory

• FDA-regulated drug study