Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03386344 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 376
- Enrollment target
NCT03386344 is a Phase 3 study that was terminated before completion, run by Lexicon Pharmaceuticals. The registered enrollment target is 376 participants.
The verdict
NCT03386344, a Phase 3 study, was terminated before completion, sponsored by Lexicon Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 376 participants
- Enrollment target
Study Summary
The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen.
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2018-02-19 |
| Est. Completion | 2020-05-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03386344
The ClinicalTrials.gov registry entry for NCT03386344 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 376 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.
NCT03386344 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03386344 about?
NCT03386344 is a clinical study titled "Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control". The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen...
What is the current status of trial NCT03386344?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 376 participants. The study started on 2018-02-19. Estimated completion is 2020-05-30.
What interventions are being tested in trial NCT03386344?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT03386344?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.