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Clinical Trial Details

Trial ID: L6746
Source ID: NCT00755287
Associated Drug: Insulin Glargine
Title: A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: insulin glargine|DRUG: metformin|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%); incidence of hypoglycemia; change from baseline in lipid profile., 24 weeks|Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test., 24 weeks|Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies, Throughout study
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1072
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-11
Completion Date: 2010-12
Results First Posted:
Last Update Posted: 2016-07-29
Locations: Phoenix, Arizona, 85032, United States|Searcy, Arkansas, 72143, United States|Concord, California, 94520, United States|Huntington Beach, California, 92648, United States|Los Angeles, California, 90015, United States|Los Angeles, California, 90025, United States|Los Gatos, California, 95032, United States|Roseville, California, 95661, United States|San Diego, California, 92109, United States|Santa Ana, California, 92705, United States|Westlake Village, California, 91361, United States|Washington, District of Columbia, 20010, United States|Green Cove Springs, Florida, 32043, United States|Hialeah, Florida, 33013, United States|Jacksonville, Florida, 32204, United States|Jacksonville, Florida, 32216, United States|Ormond Beach, Florida, 32174, United States|Oviedo, Florida, 32765, United States|Palm Harbor, Florida, 34684, United States|Trinity, Florida, 34655, United States|Zephyrhills, Florida, 33542, United States|Atlanta, Georgia, 30338, United States|Quincy, Illinois, 62301, United States|Springfield, Illinois, 62704-1433, United States|Avon, Indiana, 46123, United States|Indianapolis, Indiana, 46260, United States|Arkansas City, Kansas, 67005, United States|Crestview Hills, Kentucky, 41017, United States|Metairie, Louisiana, 70006, United States|Sunset, Louisiana, 70584, United States|Portland, Maine, 04101, United States|North East, Maryland, 21901, United States|Worchester, Massachusetts, 01605, United States|St. Claire Shores, Michigan, 48081, United States|Jackson, Mississippi, 39216, United States|Picayune, Mississippi, 39466, United States|Springfield, Missouri, 65807, United States|Grand Island, Nebraska, 68803, United States|Omaha, Nebraska, 68105, United States|Omaha, Nebraska, 68131, United States|Henderson, Nevada, 89014, United States|Blackwood, New Jersey, 08012, United States|Cherry Hill, New Jersey, 08002, United States|Moorestown, New Jersey, 08057, United States|Toms River, New Jersey, 08753, United States|Toms River, New Jersey, 08755, United States|Albany, New York, 12206-1098, United States|Flushing, New York, 11365, United States|Mineola, New York, 11501, United States|Asheville, North Carolina, 28803, United States|Harrisburg, North Carolina, 28075, United States|Fargo, North Dakota, 58103, United States|Centerville, Ohio, 45459, United States|Cincinnati, Ohio, 45242, United States|Genoa, Ohio, 43430-1143, United States|Toledo, Ohio, 43606, United States|Altoona, Pennsylvania, 16602, United States|Bensalem, Pennsylvania, 19020, United States|Feasterville, Pennsylvania, 19053, United States|Harrisburg, Pennsylvania, 17112, United States|Jefferson Hills, Pennsylvania, 15025, United States|Philadelphia, Pennsylvania, 19107, United States|Philadelphia, Pennsylvania, 19146, United States|Scranton, Pennsylvania, 18510, United States|Tipton, Pennsylvania, 16684, United States|Orangeburg, South Carolina, 29115, United States|Johnson City, Tennessee, 37604, United States|Dallas, Texas, 75230, United States|Dallas, Texas, 75246, United States|Dallas, Texas, 75390, United States|Houston, Texas, 77024, United States|Houston, Texas, 77030, United States|Richmond, Virginia, 23249, United States|Waukesha, Wisconsin, 53189, United States|St. Leonards, New South Wales, 2065, Australia|Wollongong, New South Wales, 2500, Australia|Freemantle, Queensland, 6959, Australia|Graz, 8036, Austria|Salzburg, 5020, Austria|Wien, 1030, Austria|Wien, 1080, Austria|Wien, 1130, Austria|Arlon, 6700, Belgium|Bonheiden, 2820, Belgium|Leuven, 3000, Belgium|Liège, 4000, Belgium|Recife, PE, 52051-380, Brazil|Campina Grande do Sul, PR, 83430-000, Brazil|Curitiba, PR, 80030-110, Brazil|Porto Alegre, RS, 90035-170, Brazil|Sao Paulo, SP, 04022-001, Brazil|Vancouver, British Columbia, V5Z 1L8, Canada|Hamilton, Ontario, L8S 4J9, Canada|London, Ontario, N6A 5R8, Canada|Toronto, Ontario, M5G 2C4, Canada|Pointe-Claire, Quebec, H9R 4S3, Canada|Sherbrooke, Quebec, J1G 5K2, Canada|Brno, 625 00, Czech Republic|Havirov, 76301, Czech Republic|Plzen, 301 00, Czech Republic|Praha, 180 00, Czech Republic|Trutnov, 541 01, Czech Republic|Helsinki, 00150, Finland|Jyvaeskylae, 40100, Finland|Tampere, 33100, Finland|Avignon, 84902, France|Besancon, 25030, France|Bois Guillaume, 76233, France|Brest, 29609, France|Corbeil Essonnes, 91106, France|La Rochelle, 17019, France|Marseille, 13015, France|Marseille, 13385, France|Montpellier, 34295, France|Nimes, 30029, France|Paris, 75651, France|Paris, 75877, France|Paris, 75908, France|Strasbourg, 67091, France|Venissieux, 69200, France|Bad Lauterberg, 37431, Germany|Berlin, 10115, Germany|Bochum, 44869, Germany|Bosenheim, 55545, Germany|Dortmund, 44137, Germany|Falkensee, 14612, Germany|Freiburg, 79106, Germany|Mainz, 55116, Germany|Offenbach a.M., 63065, Germany|Reichenbach, 08468, Germany|Würzburg, 97072, Germany|Athens, 10552, Greece|Larissa, 41110, Greece|Thessaloniki, 56429, Greece|Guatemala, 01010, Guatemala|Hong Kong, Hong Kong|Balatonfuered, 8230, Hungary|Budapest, 1045, Hungary|Szekszard, 7100, Hungary|Napoli, Campania, 80100, Italy|Roma, Lazio, 00157, Italy|Codogno, Lombardia, 26845, Italy|Milano, Lombardia, 20132, Italy|Milano, Lombardia, 20142, Italy|Torino, Piemonte, 10126, Italy|Daegu, 700-721, Korea, Republic of|Incheon, Korea, Republic of|Seoul, 137-040, Korea, Republic of|Aguascalientes, 20127, Mexico|Cuernavaca, 62250, Mexico|Monterrey, 64410, Mexico|Tampico, 89000, Mexico|Auckland, 1640, New Zealand|Auckland, New Zealand|Arequipa, Cercado, Peru|Lima, Lima 1, Peru|Lima, Lima 33, Peru|Trujillo, 13011, Peru|Grodzisk Mazowiecki, 05-825, Poland|Kamieniec Zabkowicki, 57-230, Poland|Lodz, 93-338, Poland|Rzeszow, 35-073, Poland|Sobótka, 55-050, Poland|Szczecin, 71-455, Poland|Wroclaw, 51-124, Poland|Coimbra, 3000-075, Portugal|Lisboa, 1250-203, Portugal|Lisboa, 1349-019, Portugal|Guyanabo, San Juan, 00920, Puerto Rico|Levittown, 00950, Puerto Rico|Orocovis, 00720, Puerto Rico|Ponce, 00717-322, Puerto Rico|San Juan, 00926-2832, Puerto Rico|Trujillo Alto, 00976, Puerto Rico|Barnaul, 656024, Russian Federation|Chelyabinsk, 454136, Russian Federation|Moscow, 117049, Russian Federation|Moscow, 125299, Russian Federation|Moscow, 129110, Russian Federation|Nizhny Novgorod, 603126, Russian Federation|Novosibirsk, 630047, Russian Federation|Omsk, 644021, Russian Federation|Saint-Petersburg, 197022, Russian Federation|St Petersburg, 195213, Russian Federation|St-Petersburg, 194291, Russian Federation|St. Petersburg, 193012, Russian Federation|St. Petersburg, 194354, Russian Federation|Tomsk, 643050, Russian Federation|Belgrade, 11000, Serbia|Kragujevac, 34000, Serbia|Nis, 18000, Serbia|Novi Sad, 21000, Serbia|Pozuelo de alarcon, Madrid, 28223, Spain|Alzira, Valencia, 46600, Spain|Almeria, 04001, Spain|Barcelona, 08025, Spain|Granada, 18012, Spain|Sevilla, 41010, Spain|Sevilla, 41013, Spain|Valencia, 46010, Spain|Valencia, 46014, Spain|Valladolid, 47005, Spain|Bangkok, 10330, Thailand|Bangkok, 10400, Thailand|Atherstone, CV9 1EU, United Kingdom|Chesterfield, S40 4TF, United Kingdom|Dumfries, DG1 4AP, United Kingdom|Liverpool, L9 7AL, United Kingdom|Sheffield, S18 1RU, United Kingdom|Trowbridge, BA14 8QA, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00755287