Safety, Tolerability, and Efficacy Study of MB07803 Administered to Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00458016
Last Updated: 2011-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2007-03-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
MB07803
Daily oral administration
2
MB07803
Daily oral administration
3
MB07803
Daily oral administration
4
MB07803
Daily oral administration
5
Placebo
Daily oral administration
Interventions
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MB07803
Daily oral administration
Placebo
Daily oral administration
Eligibility Criteria
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Inclusion Criteria
* HbA1c measurements between 6.0 - 10% at screening
* Females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). Females who are postmenopausal for at least 12 consecutive months and documented by blood follicular stimulating hormone (FSH) greater than or equal to 40 mlU/mL.Females of childbearing potential must be willing to use an approved double-barrier method of birth control (e.g. condom plus spermicide ;IUD plus spermicide) from the time of signing the informed consent form through 4 weeks following the last dose of study drug.
* Body mass index (BMI) in the range of 18.5 - 37 kg/m2 Patients with a BMI in the range of 37.5 - 40 kg/m2 who in the Investigator's opinion, are in good health and satisfy the eligibility criteria, will be considered on a case-by case basis
* Written informed consent
Exclusion Criteria
* Type 2 diabetes mellitus with a history of diabetic ketoacidosis or ketosis-prone
* Use of thiazolidinediones (TZDs)
* Currently on more than two oral hypoglycemic agent
* History of outpatient insulin use
* Clinically significant history of cardiac disease within 6 months of informed consent
18 Years
70 Years
ALL
No
Sponsors
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Ligand Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Los Angeles, California, United States
Walnut Creek, California, United States
Miami, Florida, United States
Miami Gardens, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Butte, Montana, United States
Las Vegas, Nevada, United States
Charlotte, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Delaware, Ohio, United States
Marion, Ohio, United States
Willoughby Hills, Ohio, United States
Tulsa, Oklahoma, United States
Charleston, South Carolina, United States
Bristol, Tennessee, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Countries
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Other Identifiers
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MB07803-202
Identifier Type: -
Identifier Source: org_study_id