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NCT03242018 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 277
- Enrollment target
NCT03242018 is a Phase 3 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 277 participants.
The verdict
NCT03242018, a Phase 3 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 277 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: * To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c * To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo * To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2017-08-16 |
| Est. Completion | 2019-12-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03242018
The ClinicalTrials.gov registry entry for NCT03242018 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 277 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.
NCT03242018 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03242018 about?
NCT03242018 is a clinical study titled "A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control". Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: * To assess...
What is the current status of trial NCT03242018?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 277 participants. The study started on 2017-08-16. Estimated completion is 2019-12-11.
What interventions are being tested in trial NCT03242018?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT03242018?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
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