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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.

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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

FieldValue
Enrollment Target 36 participants
Start Date 2013-02
Est. Completion 2014-01
Phase Phase 2

Sponsor

Lexicon Pharmaceuticals

56 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.