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NCT03066830 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 507
- Enrollment target
NCT03066830: Completed Phase 3 study, sponsored by Lexicon Pharmaceuticals.
NCT03066830 is a Phase 3 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 507 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03066830, a Phase 3 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 507 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin. Secondary Objectives: * To compare Sotagliflozin 400 mg versus placebo based on: * 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 (mm Hg). * Change from baseline in SBP for all participants. * Change from baseline in body weight. * Percentage of participants with HbA1c \<6.5% and \<7.0%. * To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.
Primary Outcome
Missing data are imputed using the retrieved dropouts imputation method. An analysis of covariance (ANCOVA) model was used for the analysis.
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Sulfonylurea
- DRUG Sotagliflozin (SAR439954)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2017-02-24 |
| Est. Completion | 2019-04-30 |
| Phase | Phase 3 |
What the finished NCT03066830 record still lists
NCT03066830 is an interventional study that assigns participants to a tested intervention. The registered 507 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 (34% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03066830 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03066830 about?
NCT03066830 is a clinical study titled "Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin". Primary Objective: To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin. Secondary ...
What is the current status of trial NCT03066830?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 507 participants. The study started on 2017-02-24. Estimated completion is 2019-04-30.
What interventions are being tested in trial NCT03066830?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Sulfonylurea (DRUG), Sotagliflozin (SAR439954) (DRUG).
Who is sponsoring clinical trial NCT03066830?
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 NCT03066830's enrollment target sits among peer trials
507 739th of 2000 higher than 1,260 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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