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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 is a Phase 3 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 507 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03066830
The ClinicalTrials.gov registry entry for NCT03066830 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 507 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lexicon Pharmaceuticals, which has 56 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03066830 reports 0 study locations.
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.
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