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Clinical Trial Details

Trial ID: L2932
Source ID: NCT00823992
Associated Drug: Placebo
Title: A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: placebo|DRUG: taspoglutide
Outcome Measures: Primary: Absolute change from baseline in HbA1c, 24 weeks | Secondary: Change from baseline in body weight;% of patients achieving >=5% weight loss, 24 weeks|% of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function, 24 weeks|Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n, At planned clinic visits, for 12 months
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 305
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-01
Completion Date: 2010-05
Results First Posted:
Last Update Posted: 2016-07-28
Locations: Bermuda Dunes, California, 92203, United States|Lajolla, California, 92037, United States|Los Angeles, California, 90057, United States|Mission Viejo, California, 92691, United States|Brooksville, Florida, 34601, United States|Miami, Florida, 33133, United States|St. Petersburg, Florida, 33709, United States|Atlanta, Georgia, 30342, United States|Chicago, Illinois, 60607, United States|Avon, Indiana, 46123, United States|New Orleans, Louisiana, 70121, United States|Bangor, Maine, 04401, United States|Royal Oak, Michigan, 48073, United States|Picayune, Mississippi, 39466, United States|Clifton, New Jersey, 07012, United States|Toms River, New Jersey, 08753, United States|Albuquerque, New Mexico, 87131, United States|New York, New York, 10025, United States|Springfield Gardens, New York, 11413, United States|Charlotte, North Carolina, 28277, United States|Shelby, North Carolina, 28150, United States|Norman, Oklahoma, 73069, United States|Medford, Oregon, 97504, United States|Clinton, South Carolina, 29325, United States|Kingsport, Tennessee, 37660, United States|Dallas, Texas, 75246, United States|Houston, Texas, 77074, United States|Midland, Texas, 79707, United States|San Antonio, Texas, 78237, United States|Vancouver, British Columbia, V5Z 1L8, Canada|Sherbrooke, Nova Scotia, J1G 2E8, Canada|Etobicoke, Ontario, M9R 4E1, Canada|Hamilton, Ontario, L8N 3Z5, Canada|Oakville, Ontario, L6H 3P1, Canada|Toronto, Ontario, M9W 4L6, Canada|Aschaffenburg, 63739, Germany|Berlin, 10115, Germany|Bochum, 44791, Germany|Dortmund, 44137, Germany|Dresden, 01307, Germany|Falkensee, 14612, Germany|Mainz, 55116, Germany|Münster, 48145, Germany|Neuwied, 56564, Germany|Ancona, 60131, Italy|Ravenna, 48100, Italy|Roma, 00161, Italy|Siena, 53100, Italy|Bitola, 7000, Macedonia, The Former Yugoslav Republic of|Gniewkowo, 88-140, Poland|Kamieniec Zabkowicki, 57-230, Poland|Lublin, 20-044, Poland|Carolina, 00983, Puerto Rico|Rio Grande, 00745, Puerto Rico|Rio Piedras, 00921, Puerto Rico|Kemerovo, 650002, Russian Federation|Moscow, 105229, Russian Federation|Moscow, 115280, Russian Federation|Moscow, 117036, Russian Federation|Ryazan, 390026, Russian Federation|Saratov, 410002, Russian Federation|Smolensk, 214019, Russian Federation|Tumen, 625023, Russian Federation|Barcelona, 08036, Spain|Lerida, 25198, Spain|Oviedo, 33006, Spain|Bath, BA2 4BY, United Kingdom|Birmingham, B9 5SS, United Kingdom|Glasgow, G45 9AW, United Kingdom|Midsomer Norton, BA3 2UH, United Kingdom|Rotherham, S65 1DA, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00823992