Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Type 2 Diabetes Mellitus, sponsored by Lexicon Pharmaceuticals.
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 2,958-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
What the finished NCT01376557 record still lists
NCT01376557 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, below the 2,958-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (90% lower).
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 names 20 study sites across 6 states, led by 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.
Learn More About Clinical Trials
Similar trials for Type 2 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 NCT01376557's enrollment target sits among peer trials
299 27th of 130 higher than 104 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 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
-
A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes
RECRUITING · Phase 2
-
Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease
RECRUITING · Phase 2
-
Regulation of Endogenous Glucose Production by Central KATP Channels
RECRUITING · Phase 2
-
Signaling Mechanisms and Vascular Function in Patients With Diabetes Mellitus
COMPLETED · Phase 2
-
The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes
COMPLETED · Phase 2
-
A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00353483 · 300 participants
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
- NCT00588185 · 300 participants · NA
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
- NCT00682032 · 300 participants · NA
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
- NCT00870064 · 300 participants · NA
The Treatment of Type I Open Fractures in Pediatrics
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia