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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 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 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (74% lower). The trial reports 7 study locations across 7 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01742208
The ClinicalTrials.gov registry entry for NCT01742208 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (74% lower). The listed sponsor is Lexicon Pharmaceuticals, which has 56 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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