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Clinical Trial Details

Trial ID: L5682
Source ID: NCT01464437
Associated Drug: Amg 151
Title: AMG 151 Amgen Protocol Number 20100761
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: AMG 151|DRUG: Placebo|DRUG: Metformin|DRUG: AMG 151|DRUG: AMG 151|DRUG: AMG 151|DRUG: AMG 151|DRUG: AMG 151
Outcome Measures: Primary: To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin, Change in fasting plasma glucose levels from baseline to Day 28 | Secondary: To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test, Change in area under the curve from 0-4 hours (AUC0-4hr) glucose after a meal tolerancetest from baseline to Day 28, Change in incremental AUC0-4hr glucose after a meal tolerance test from baseline to Day 28|Adverse events, Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 236
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-09
Completion Date: 2012-12
Results First Posted:
Last Update Posted: 2014-05-13
Locations: Research Site, Birmingham, Alabama, 35216, United States|Research Site, Phoenix, Arizona, 85021, United States|Research Site, Tucson, Arizona, 85704, United States|Research Site, Little Rock, Arkansas, 72205, United States|Research Site, Anaheim, California, 92801, United States|Research Site, Chula Vista, California, 91911, United States|Research Site, Fresno, California, 93720, United States|Research Site, Greenbrae, California, 94904, United States|Research Site, Inglewood, California, 90301, United States|Research Site, Lomita, California, 90717, United States|Research Site, Los Angeles, California, 90017, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, Palm Desert, California, 92260, United States|Research Site, Roseville, California, 95661, United States|Research Site, San Diego, California, 92161, United States|Research Site, San Jose, California, 95123, United States|Research Site, Walnut Creek, California, 94598, United States|Research Site, Watsonville, California, 95076, United States|Research Site, Bradenton, Florida, 34208, United States|Research Site, Brooksville, Florida, 34601, United States|Research Site, Clearwater, Florida, 33756, United States|Research Site, Fort Myers, Florida, 33912, United States|Research Site, Kissimmee, Florida, 34741, United States|Research Site, Maitland, Florida, 32751, United States|Research Site, Palm Harbor, Florida, 34684, United States|Research Site, Saint Petersburg, Florida, 33716, United States|Research Site, St. Petersburg, Florida, 33709, United States|Research Site, Tampa, Florida, 33606, United States|Research Site, Winter Park, Florida, 32789, United States|Research Site, Atlanta, Georgia, 30338, United States|Research Site, Columbus, Georgia, 31904, United States|Research Site, Dunwoody, Georgia, 30338, United States|Research Site, Roswell, Georgia, 30076, United States|Research Site, Meridian, Idaho, 83642, United States|Research Site, Chigago, Illinois, 60607, United States|Research Site, Indianapolis, Indiana, 46202, United States|Research Site, Metairie, Louisiana, 70006, United States|Research Site, Bethesda, Maryland, 20817, United States|Research Site, St. Louis, Missouri, 63128, United States|Research Site, Bozeman, Montana, 59718, United States|Research Site, Las Vegas, Nevada, 89106, United States|Research Site, Las Vegas, Nevada, 89117, United States|Research Site, Mineola, New York, 11501, United States|Research Site, Raleigh, North Carolina, 27612, United States|Research Site, Shelby, North Carolina, 28150, United States|Research Site, Bismarck, North Dakota, 58503, United States|Research Site, Fargo, North Dakota, 58103, United States|Research Site, Cincinnati, Ohio, 45227, United States|Research Site, Cleveland, Ohio, 44122, United States|Research Site, Dayton, Ohio, 45439, United States|Research Site, Kettering, Ohio, 45429, United States|Research Site, Norman, Oklahoma, 73069, United States|Research Site, Oklahoma City, Oklahoma, 73112, United States|Research Site, Rapid City, South Dakota, 57702, United States|Research Site, Dallas, Texas, 75235, United States|Research Site, Dallas, Texas, 75247, United States|Research Site, Houston, Texas, 77029, United States|Research Site, Houston, Texas, 77074, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Draper, Utah, 84020, United States|Research Site, Salt Lake City, Utah, 84124, United States|Research Site, Midlothian, Virginia, 23114, United States|Research Site, Norfolk, Virginia, 23510, United States|Research Site, Richmond, Virginia, 23219, United States|Research Site, Salem, Virginia, 24153, United States|Research Site, Brno, 602 00, Czech Republic|Research Site, Pardubice, 530 02, Czech Republic|Research Site, Praha 3, 130 00, Czech Republic|Research Site, Tallinn, 10128, Estonia|Research Site, Lodz, 90-368, Poland|Research Site, Warszawa, 04-730, Poland|Research Site, Carolina, 00983, Puerto Rico|Research Site, Cidra, 00739, Puerto Rico|Research Site, San Juan, 00909, Puerto Rico|Research Site, San Juan, 00917, Puerto Rico|Research Site, San Juan, 00920, Puerto Rico|Research Site, San Juan, 00926-2832, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT01464437

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D331 Amiodarone small molecule DB01118 Details
D089 Metformin small molecule DB00331 Details