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NCT03332771 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 954
- Enrollment target
NCT03332771: Completed Phase 3 study, sponsored by Lexicon Pharmaceuticals.
NCT03332771 is a Phase 3 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 954 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03332771, a Phase 3 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 954 participants
- Enrollment target
Study 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.
Primary Outcome
An analysis of covariance (ANCOVA) model was used for the analysis.
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Glimepiride
- DRUG Sotagliflozin (SAR439954)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 954 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2019-09-06 |
| Phase | Phase 3 |
What the finished NCT03332771 record still lists
NCT03332771 is an interventional study that assigns participants to a tested intervention. The registered 954 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03332771 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03332771 about?
NCT03332771 is a clinical study titled "Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy". 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 th...
What is the current status of trial NCT03332771?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 954 participants. The study started on 2017-12-01. Estimated completion is 2019-09-06.
What interventions are being tested in trial NCT03332771?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Glimepiride (DRUG), Sotagliflozin (SAR439954) (DRUG).
Who is sponsoring clinical trial NCT03332771?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03332771's enrollment target sits among peer trials
954 333rd of 2000 higher than 1,668 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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