Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02926950 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 518
- Enrollment target
NCT02926950: Completed Phase 3 study, sponsored by Lexicon Pharmaceuticals.
NCT02926950 is a Phase 3 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 518 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02926950, a Phase 3 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 518 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate the superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: * To compare Sotagliflozin versus placebo for. * Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal. * Change from baseline in fasting plasma glucose (FPG). * Change from Baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mmHg). * Change from baseline in SBP for all participants. * Change from baseline in body weight. * Proportion of participants with HbA1c \<6.5% and \<7.0%. * To evaluate the safety of Sotagliflozin versus placebo.
Primary Outcome
An analysis of covariance (ANCOVA) model was used for the analysis.
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Sotagliflozin (SAR439954)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2016-11 |
| Est. Completion | 2019-03-22 |
| Phase | Phase 3 |
What the finished NCT02926950 record still lists
NCT02926950 is an interventional study that assigns participants to a tested intervention. The registered 518 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02926950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02926950 about?
NCT02926950 is a clinical study titled "Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin". Primary Objective: To demonstrate the superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: * To compare Sotagliflozin versus placebo for. * Change from ...
What is the current status of trial NCT02926950?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 518 participants. The study started on 2016-11. Estimated completion is 2019-03-22.
What interventions are being tested in trial NCT02926950?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Sotagliflozin (SAR439954) (DRUG).
Who is sponsoring clinical trial NCT02926950?
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 NCT02926950's enrollment target sits among peer trials
518 723rd of 2000 higher than 1,277 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04524871 · 518 participants · Phase 1
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)
- NCT07112196 · 518 participants · Phase 2
Visugromab in Cachexia International Trial
- NCT05676450 · 517 participants · NA
Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas
- NCT02323581 · 520 participants · NA
Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia