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NCT01376557 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin

A Phase 2 study of Type 2 Diabetes Mellitus, sponsored by Lexicon Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
299
Enrollment target
20
Study locations

NCT01376557 is a Phase 2 study of Type 2 Diabetes Mellitus that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 299 participants, below the 2,746-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT01376557, a Phase 2 study of Type 2 Diabetes Mellitus, has completed, sponsored by Lexicon Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
299 participants
Enrollment target
20
Study locations

Study Summary

This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.

Conditions Studied

Type 2 Diabetes Mellitus

Interventions

  • DRUG Placebo
  • DRUG 75 mg LX4211
  • DRUG 200 mg LX4211
  • DRUG 400 mg LX4211

Study Locations (20)

California

  • Lexicon Investigational Site - Anaheim
  • Lexicon Investigational Site - Carmichael
  • Lexicon Investigational Site - Greenbrae
  • Lexicon Investigational Site - La Jolla
  • Lexicon Investigational Site - Northridge
  • Lexicon Investigational Site - Orange
  • Lexicon Investigational Site - Pismo Beach
  • Lexicon Investigational Site - Tarzana
  • Lexicon Investigational Site - Tustin

Florida

  • Lexicon Investigational Site - Edgewater
  • Lexicon Investigational Site - Miami
  • Lexicon Investigational Site - Orlando
  • Lexicon Investigational Site - West Palm Beach
  • Lexicon Investigational Site - Winter Park

Colorado

  • Lexicon Investigational Site - Denver
  • Lexicon Investigational Site - Denver

Georgia

  • Lexicon Investigational Site - Blue Ridge
  • Lexicon Investigational Site - Savannah

Delaware

  • Lexicon Investigational Site - Newark

Indiana

  • Lexicon Investigational Site - Lafayette

Trial Details

FieldValue
Enrollment Target 299 participants
Start Date 2011-06
Est. Completion 2012-05
Phase Phase 2

Sponsor

Lexicon Pharmaceuticals

56 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01376557

The ClinicalTrials.gov registry entry for NCT01376557 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 299 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,746-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (89% 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 2 Diabetes Mellitus appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT01376557 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Colorado.

Frequently Asked Questions

What is clinical trial NCT01376557 about?

NCT01376557 is a clinical study titled "Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin". This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.

What is the current status of trial NCT01376557?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 299 participants. The study started on 2011-06. Estimated completion is 2012-05.

What conditions does trial NCT01376557 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.

What interventions are being tested in trial NCT01376557?

The interventions under investigation include: Placebo (DRUG), 75 mg LX4211 (DRUG), 200 mg LX4211 (DRUG), 400 mg LX4211 (DRUG).

Who is sponsoring clinical trial NCT01376557?

This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01376557 being conducted?

This trial has 20 study locations across California, Colorado, Delaware, Florida, Georgia. 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.