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NCT02384941 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 793
- Enrollment target
NCT02384941: Completed Phase 3 study, sponsored by Lexicon Pharmaceuticals.
NCT02384941 is a Phase 3 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 793 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02384941, a Phase 3 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 793 participants
- Enrollment target
Study Summary
This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.
Primary Outcome
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative chang
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 793 participants |
| Start Date | 2015-03 |
| Est. Completion | 2017-02 |
| Phase | Phase 3 |
What the finished NCT02384941 record still lists
NCT02384941 is an interventional study that assigns participants to a tested intervention. The registered 793 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02384941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02384941 about?
NCT02384941 is a clinical study titled "Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy". This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control wit...
What is the current status of trial NCT02384941?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 793 participants. The study started on 2015-03. Estimated completion is 2017-02.
What interventions are being tested in trial NCT02384941?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT02384941?
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 NCT02384941's enrollment target sits among peer trials
793 429th of 2000 higher than 1,572 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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