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Clinical Trial Details

Trial ID: L3594
Source ID: NCT00744367
Associated Drug: Metformin
Title: A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: metformin|DRUG: pioglitazone|DRUG: placebo|DRUG: taspoglutide|DRUG: taspoglutide
Outcome Measures: Primary: Absolute change from baseline in HbA1c, 24 weeks | Secondary: Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; beta cell function., 24 weeks|Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies., Throughout the study
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 326
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-10
Completion Date: 2010-11
Results First Posted:
Last Update Posted: 2016-08-05
Locations: Birmingham, Alabama, 35209, United States|Birmingham, Alabama, 35294, United States|Huntsville, Alabama, 35801, United States|Muscle Shoals, Alabama, 35661, United States|Phoenix, Arizona, 85028, United States|Phoenix, Arizona, 85032, United States|Buena Park, California, 90620, United States|Lancaster, California, 93534, United States|Loma Linda, California, 92354, United States|Rancho Cucamonga, California, 91730, United States|Roseville, California, 95661, United States|San Diego, California, 92161, United States|Walnut Creek, California, 94598, United States|Wheatridge, Colorado, 80033, United States|Hamden, Connecticut, 06518, United States|Washington, District of Columbia, 20017, United States|Bradenton, Florida, 34208, United States|Chiefland, Florida, 32626, United States|Fort Myers, Florida, 33907, United States|Gainesville, Florida, 32607, United States|Hollywood, Florida, 33021, United States|Miami, Florida, 33136, United States|New Port Richey, Florida, 34652, United States|Ocala, Florida, 34474, United States|Plantation, Florida, 33317, United States|Tampa, Florida, 33614, United States|Nampa, Idaho, 83687, United States|Aurora, Illinois, 60504, United States|Libertyville, Illinois, 60048, United States|Evansville, Indiana, 47714, United States|Des Moines, Iowa, 50314, United States|Topeka, Kansas, 66614, United States|Lexington, Kentucky, 40504, United States|Madisonville, Kentucky, 42431, United States|New Orleans, Louisiana, 70121, United States|Frederick, Maryland, 21702, United States|Oxon Hill, Maryland, 20745, United States|Detroit, Michigan, 48202, United States|Ferndale, Michigan, 48220, United States|Kalamazoo, Michigan, 49048, United States|Biloxi, Mississippi, 39531, United States|Olive Branch, Mississippi, 38654, United States|St Peters, Missouri, 63376, United States|Omaha, Nebraska, 68114, United States|Omaha, Nebraska, 68131, United States|Las Vegas, Nevada, 89148, United States|Albany, New York, 12206-1098, United States|Brooklyn, New York, 11218, United States|Hudson, New York, 12534, United States|Lake Success, New York, 11042, United States|Staten Island, New York, 10301, United States|Charlotte, North Carolina, 28262, United States|Charlotte, North Carolina, 28277, United States|Mooresville, North Carolina, 28117, United States|Wilmington, North Carolina, 28401, United States|Bismarck, North Dakota, 58501, United States|Athens, Ohio, 45701, United States|Cincinnati, Ohio, 45219, United States|Kettering, Ohio, 45429, United States|Norman, Oklahoma, 73071, United States|Medford, Oregon, 97504, United States|Beaver, Pennsylvania, 15009, United States|Bensalem, Pennsylvania, 19020, United States|Carlisle, Pennsylvania, 17015, United States|Levittown, Pennsylvania, 19056, United States|Melrose Park, Pennsylvania, 19027, United States|Pittsburgh, Pennsylvania, 15236, United States|Cranston, Rhode Island, 02920, United States|Greer, South Carolina, 29651, United States|Bellaire, Texas, 77401, United States|Dallas, Texas, 75230, United States|Dallas, Texas, 75231, United States|Houston, Texas, 77030, United States|San Antonio, Texas, 78205, United States|Salt Lake City, Utah, 84102, United States|Federal Way, Washington, 98003, United States|Brasilia, 70390-155, Brazil|Forlateza, 60430-350, Brazil|Fortaleza, 60120-021, Brazil|Fortaleza, 60155-290, Brazil|Fortaleza, 60430-370, Brazil|Mogi Das Cruzes - Sp, 08780-090, Brazil|Passo Fundo, 99010-901, Brazil|Porto Alegre, 90035-001, Brazil|Recife, 50100-130, Brazil|Sao Paulo, 01221-020, Brazil|Sao Paulo, 01244-030, Brazil|Sao Paulo, 04022-001, Brazil|Sao Paulo, 05403-000, Brazil|Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|Hamilton, Ontario, L8N 3Z5, Canada|London, Ontario, N6A 5R8, Canada|Toronto, Ontario, M9W 4L6, Canada|Montreal, Quebec, H2W 1T8, Canada|Pointe-claire, Quebec, H9R 4S3, Canada|San Jose, 755-1000, Costa Rica|Bondy, 93143, France|Dijon, 21079, France|Nantes, 44093, France|Narbonne, 11108, France|Falkensee, 14612, Germany|Karlsruhe, 76199, Germany|Mainz, 55116, Germany|Neuwied, 56564, Germany|Potsdam, 14469, Germany|Guatemala, 01010, Guatemala|Guatemala, Guatemala|Chihuahua, 31238, Mexico|Jalisco, 44690, Mexico|Mexico City, 11650, Mexico|Carolina, 00983, Puerto Rico|Guyanabo, San Juan, 00920, Puerto Rico|San Juan, 00926-2832, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00744367

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details
D336 Pioglitazone small molecule DB01132 Details