At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Sotagliflozin, Insulin glargine (HOE901), and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 571 participants across 106 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
Pharmaceutical form: Tablet Route of administration: Oral
Pharmaceutical form: Solution Route of administration: Subcutaneous
Pharmaceutical form: Tablet Route of administration: Oral
OADs (including metformin) as prescribed by the investigator as per local labeling.