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NCT02459899 · ClinicalTrials.gov registry record · Phase 2
Dose-ranging Study in Patients With Type 1 Diabetes Mellitus
A Phase 2 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 141
- Enrollment target
NCT02459899: Completed Phase 2 study, sponsored by Lexicon Pharmaceuticals.
NCT02459899 is a Phase 2 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 141 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02459899, a Phase 2 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 141 participants
- Enrollment target
Study Summary
The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.
Primary Outcome
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion \[CSII\] or multiple daily injection \[MDI\]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
What the finished NCT02459899 record still lists
NCT02459899 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02459899 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02459899 about?
NCT02459899 is a clinical study titled "Dose-ranging Study in Patients With Type 1 Diabetes Mellitus". The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.
What is the current status of trial NCT02459899?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2015-07. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02459899?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT02459899?
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 NCT02459899's enrollment target sits among peer trials
141 510th of 2000 higher than 1,489 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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