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NCT01742208 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus
A Phase 2 study of Type 1 Diabetes Mellitus, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 7
- Study locations
NCT01742208: Completed Phase 2 study of Type 1 Diabetes Mellitus, sponsored by Lexicon Pharmaceuticals.
NCT01742208 is a Phase 2 study of Type 1 Diabetes Mellitus that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 36 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (79% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01742208, a Phase 2 study of Type 1 Diabetes Mellitus, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 7
- Study locations
Study Summary
This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).
Primary Outcome
Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\]/number of assessments)/baseline over Days 3 to 27. Least squares (LS) Means and confidence interval (CI) for the Expansion groups were based on an analysis of covariance (ANCOVA) model with covariates of baseline mean total bolus insulin, treatment group, factor used to stratify
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Study Locations (7)
Colorado
- Lexicon Investigational Site - Aurora
Georgia
- Lexicon Investigational Site - Atlanta
Louisiana
- Lexicon Investigational Site - Baton Rouge
Nebraska
- Lexicon Investigational Site - Omaha
New York
- Lexicon Investigational Site - The Bronx
North Carolina
- Lexicon Investigational Site - Durham
Texas
- Lexicon Investigational Site - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
What the finished NCT01742208 record still lists
NCT01742208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01742208 lists 7 locations in 7 states (Colorado, Georgia, Louisiana).
Frequently Asked Questions
What is clinical trial NCT01742208 about?
NCT01742208 is a clinical study titled "Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus". This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).
What is the current status of trial NCT01742208?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2013-02. Estimated completion is 2014-01.
What conditions does trial NCT01742208 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT01742208?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT01742208?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01742208 being conducted?
This trial has 7 study locations across Colorado, Georgia, Louisiana, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01742208's enrollment target sits among peer trials
36 64th of 112 higher than 47 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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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