NCT03332771

Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

A 52-week Randomized, Double-blind, Double-dummy, Active and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Glimepiride or Placebo Added to Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 954 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter \[mg/dL\]). * To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants. * To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c. * To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. * To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. * To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.

Detailed description

Up to 58 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks, a 2-week single-blind placebo Run-in phase, a 52-week double-blind Treatment Period, and a 2-week post-treatment Follow-up period to collect safety information.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin (SAR439954)	Pharmaceutical form: tablet Route of administration: oral
DRUG	Glimepiride	Pharmaceutical form: capsule Route of administration: oral
DRUG	Metformin	Pharmaceutical form: tablet Route of administration: oral
DRUG	Placebo	Pharmaceutical form: tablet Route of administration: oral
DRUG	Placebo	Pharmaceutical form: capsule Route of administration: oral

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-08-06
• Completion: 2019-09-06
• First posted: 2017-11-06
• Last updated: 2021-05-11
• Results posted: 2021-05-11

Locations

142 sites across 4 countries: United States, Bulgaria, Hungary, Slovakia

Regulatory

• FDA-regulated drug study