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

NCT01376557 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2014-10-31

Study results available
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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

Interventions

DRUG

75 mg LX4211

Subjects will receive 75 mg LX4211 once daily

DRUG

200 mg LX4211

Subjects will receive 200 mg LX4211 once daily.

DRUG

400 mg LX4211

Subjects will receive 400 mg LX4211 once daily.

DRUG

200 mg LX4211

Subjects will receive 200 mg LX4211 twice daily.

DRUG

Placebo

Subjects will receive placebo once daily.

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Ikenna Ogbaa, MD · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01376557 on ClinicalTrials.gov