Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
NCT ID: NCT01066715
Last Updated: 2011-10-04
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
421 participants
INTERVENTIONAL
2010-01-31
2011-07-31
Brief Summary
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Study X052078 is designed to establish efficacious dose(s) for future studies based on improvement in HbA1c.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Sterile solution subcutaneously administered monthly for 6 months
XOMA 052
XOMA 052
Sterile solution subcutaneously administered monthly for 6 months
Interventions
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XOMA 052
Sterile solution subcutaneously administered monthly for 6 months
Placebo
Sterile solution subcutaneously administered monthly for 6 months
Eligibility Criteria
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Inclusion Criteria
* HbA1c ≥ 6.8% and ≤ 10.0%
* Have been on a stable regimen of metformin monotherapy for at least 12 weeks prior to Day 0
* Willingness to maintain stable diet and exercise regime throughout the study
* Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study
Exclusion Criteria
* History of malignancy within 5 years
* History of allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Advanced stage heart failure (New York Heart Association \[NYHA\] class 3 or 4)
* Clinically significant uncontrolled arrhythmias
* History of tuberculosis
* Active leg, foot, or decubitus ulcer
* Any significant inflammatory, rheumatologic, or systemic autoimmune disease
* History of chronic infections
* History or any symptoms of a demyelinating disease
* Major surgery within 3 months
* Female subjects who are pregnant, planning to become pregnant
18 Years
75 Years
ALL
No
Sponsors
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XOMA (US) LLC
INDUSTRY
Responsible Party
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Locations
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Huntsville, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Chino, California, United States
Escondido, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
National City, California, United States
Palm Springs, California, United States
Sacramento, California, United States
San Diego, California, United States
Tarzana, California, United States
Walunt Creek, California, United States
Bradenton, Florida, United States
Brooksville, Florida, United States
Coral Gables, Florida, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Port Orange, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Newton, Kansas, United States
Columbia, Maryland, United States
Oxon Hill, Maryland, United States
Edina, Minnesota, United States
St Louis, Missouri, United States
Butte, Montana, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
New York, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Hickory, North Carolina, United States
Statesville, North Carolina, United States
Wilmington, North Carolina, United States
Wilson, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Kettering, Ohio, United States
Lynhurst, Ohio, United States
Wadsworth, Ohio, United States
Willoughby Hills, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Greer, South Carolina, United States
Kingsport, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Orem, Utah, United States
West Jordan, Utah, United States
Burke, Virginia, United States
Virginia Beach, Virginia, United States
Renton, Washington, United States
Countries
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Other Identifiers
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X052078
Identifier Type: -
Identifier Source: org_study_id