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NCT03242252 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 787
- Enrollment target
NCT03242252 is a Phase 3 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 787 participants.
The verdict
NCT03242252, a Phase 3 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 787 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 787 participants |
| Start Date | 2017-08-16 |
| Est. Completion | 2019-10-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03242252
The ClinicalTrials.gov registry entry for NCT03242252 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 787 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 2 interventions - of which Placebo is the first listed.
NCT03242252 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03242252 about?
NCT03242252 is a clinical study titled "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". 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 ...
What is the current status of trial NCT03242252?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 787 participants. The study started on 2017-08-16. Estimated completion is 2019-10-25.
What interventions are being tested in trial NCT03242252?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT03242252?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
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