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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: Clinical Trial Phase 3 study, sponsored by Lexicon Pharmaceuticals.
NCT03386344 is a Phase 3 study that was terminated before completion, run by Lexicon Pharmaceuticals. The registered enrollment target is 376 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An analysis of covariance (ANCOVA) model is used for analysis.
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 |
Why NCT03386344 stopped before completion
NCT03386344 is an interventional study that assigns participants to a tested intervention. The registered 376 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 (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03386344 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03386344's enrollment target sits among peer trials
376 988th of 2000 higher than 1,013 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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