Trials / Completed
CompletedNCT03242252
Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate 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 Moderate Renal Impairment Who Have Inadequate Glycemic Control
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 787 (actual)
- Sponsor
- Lexicon Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment. Secondary Objectives: * To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight. * To evaluate the safety of Sotagliflozin 200 mg and 400 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily. Route of administration: Oral |
| DRUG | Sotagliflozin | Sotagliflozin 200 mg, tablet, orally once daily. Route of administration: Oral |
Timeline
- Start date
- 2017-08-16
- Primary completion
- 2019-03-25
- Completion
- 2019-10-25
- First posted
- 2017-08-08
- Last updated
- 2021-06-25
- Results posted
- 2021-06-25
Locations
170 sites across 16 countries: United States, Argentina, Brazil, Canada, Colombia, Germany, Hungary, Israel, Italy, Mexico, Poland, Romania, Russia, South Africa, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03242252. Inclusion in this directory is not an endorsement.