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Clinical Trial Details

Trial ID: L6181
Source ID: NCT01066715
Associated Drug: Xoma 052
Title: Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: XOMA 052|DRUG: Placebo
Outcome Measures: Primary: Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182, Day 0 pre-dose and Day 182 | Secondary: Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, daily fasting blood glucose measured by the subject using a glucose monitor, and treatment-emergent adverse events., Day 0 through Day 182|Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points, Day 0 pre-dose through Day 182|Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points, Day 0 pre-dose through Day 182|Markers of cardiovascular disease: mean change from baseline (Day 0 pre-dose) at measured time points, Day 0 pre-dose through Day 182|Serum levels of XOMA 052 (select sites only), Day 28 pre-dose, Day 168 pre-dose, and Day 182
Sponsor/Collaborators: Sponsor: XOMA (US) LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 421
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-01
Completion Date: 2011-07
Results First Posted:
Last Update Posted: 2011-10-04
Locations: 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|Ft. 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
URL: https://clinicaltrials.gov/show/NCT01066715

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress