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NCT02531035 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,405
- Enrollment target
NCT02531035: Completed Phase 3 study, sponsored by Lexicon Pharmaceuticals.
NCT02531035 is a Phase 3 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 1,405 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02531035, a Phase 3 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,405 participants
- Enrollment target
Study Summary
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).
Primary Outcome
The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value \<7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia.
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,405 participants |
| Start Date | 2015-09 |
| Est. Completion | 2017-04 |
| Phase | Phase 3 |
What the finished NCT02531035 record still lists
NCT02531035 is an interventional study that assigns participants to a tested intervention. Its 1,405 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02531035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02531035 about?
NCT02531035 is a clinical study titled "A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone". This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).
What is the current status of trial NCT02531035?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,405 participants. The study started on 2015-09. Estimated completion is 2017-04.
What interventions are being tested in trial NCT02531035?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT02531035?
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 NCT02531035's enrollment target sits among peer trials
1,405 172nd of 2000 higher than 1,829 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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