Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6400
Source ID: NCT00754988
Associated Drug: Metformin
Title: A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: Metformin|DRUG: Placebo (matching sitagliptin)|DRUG: Placebo (matching taspoglutide)|DRUG: Sitagliptin|DRUG: Taspoglutide
Outcome Measures: Primary: Mean changes 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; change from baseline in lipid profile; beta cell function., 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: 666
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-10
Completion Date: 2011-03
Results First Posted:
Last Update Posted: 2016-11-04
Locations: Birmingham, Alabama, 35233, United States|Huntsville, Alabama, 35802, United States|Tallassee, Alabama, 36078, United States|Scottsdale, Arizona, 85254, United States|Little Rock, Arkansas, 72205, United States|Huntington Beach, California, 92646, United States|La Jolla, California, 92037, United States|Los Angeles, California, 90017, United States|Roseville, California, 95661, United States|San Francisco, California, 94109, United States|Tacoma, California, 98405, United States|Colorado Springs, Colorado, 80904, United States|New London, Connecticut, 06320, United States|Manati, District of Columbia, 00674, United States|Daytona Beach, Florida, 32117, United States|Hialeah, Florida, 33012, United States|Jacksonville, Florida, 32205, United States|Miami, Florida, 33186, United States|Panama City, Florida, 32401, United States|Tampa, Florida, 33606, United States|Augusta, Georgia, 30904, United States|Conyers, Georgia, 30094, United States|Snellville, Georgia, 30029, United States|Honolulu, Hawaii, 96813, United States|Indianapolis, Indiana, 46229, United States|Indianapolis, Indiana, 46254, United States|Lafayette, Indiana, 47905, United States|South Bend, Indiana, 46628, United States|Baltimore, Maryland, 21229, United States|Brockton, Massachusetts, 02301, United States|Cadillac, Michigan, 49601, United States|Brooklyn Center, Minnesota, 55430, United States|Minneapolis, Minnesota, 55416, United States|St. Peters, Missouri, 63376, United States|Fulton, New York, 13069, United States|Hudson, New York, 12534, United States|Rochester, New York, 14609, United States|Charlotte, North Carolina, 28211, United States|Raleigh, North Carolina, 27609, United States|Shelby, North Carolina, 28150, United States|Statesville, North Carolina, 28625, United States|Winston-Salem, North Carolina, 27103, United States|Columbus, Ohio, 43213, United States|Delaware, Ohio, 43015, United States|Marion, Ohio, 43302, United States|Corvallis, Oregon, 97330, United States|Eugene, Oregon, 97401, United States|Aliquippa, Pennsylvania, 15001, United States|Beaver, Pennsylvania, 15009, United States|Erie, Pennsylvania, 16508, United States|Reading, Pennsylvania, 17601, United States|Reading, Pennsylvania, 19606, United States|Shippensburg, Pennsylvania, 17257, United States|Warminster, Pennsylvania, 18974, United States|Anderson, South Carolina, 29621, United States|Kingsport, Tennessee, 37660, United States|Dallas, Texas, 75230, United States|Houston, Texas, 77030, United States|South Burlington, Vermont, 05403, United States|Hampton, Virginia, 23666, United States|Norfolk, Virginia, 23502, United States|Richmond, Virginia, 23249, United States|Richmond, Virginia, 23294, United States|Federal Way, Washington, 98003, United States|Buenos Aires, C1012, Argentina|Buenos Aires, C1213AAH, Argentina|Mar del Plata, B7600DHK, Argentina|Freemantle, Queensland, 6959, Australia|Adelaide, South Australia, 5000, Australia|London, Ontario, N6A 4V2, Canada|Thornhill, Ontario, L4J 8L7, Canada|Toronto, Ontario, M9W 4L6, Canada|Montreal, Quebec, H2W 1T8, Canada|Pointe-Claire, Quebec, H9R 4S3, Canada|Bondy, 93143, France|Nantes, 44093, France|Poitiers, 86021, France|Rennes, 35203, France|St Mande, 94163, France|Berlin, 10115, Germany|Dormagen, 41539, Germany|Dresden, 01307, Germany|Kiel Kronshagen, 24119, Germany|Muenchen, 80336, Germany|Sulzbach-Rosenberg, 92237, Germany|Villingen-Schwenningen, 78048, Germany|Larissa, 41110, Greece|Gyeonggi-do, 443-380, Korea, Republic of|Gyeonggi-do, Korea, Republic of|Seoul, 152-703, Korea, Republic of|Seoul, Korea, Republic of|Wonju, 220-701, Korea, Republic of|Cuernavaca, 62250, Mexico|Hermosillo, 83200, Mexico|Jalisco, 44690, Mexico|Mexico City, 06700, Mexico|Mexico City, 11520, Mexico|Monterrey, 64000, Mexico|Pachuca, 42086, Mexico|Elverum, 2401, Norway|Oslo, 0027, Norway|Oslo, 0176, Norway|Oslo, 0407, Norway|Lima, Lima 33, Peru|Lima, Lima 9, Peru|Bialystok, 15-445, Poland|Gdansk, 80-858, Poland|Kamieniec Zabkowicki, 57-230, Poland|Rzeszow, 35-073, Poland|Skierniewice, 96-100, Poland|Sobótka, 55-050, Poland|Wroclaw, 51-124, Poland|Caguas, 00725, Puerto Rico|Carolina, 00983, Puerto Rico|Bucuresti, 020359, Romania|Buzau, 120203, Romania|Cluj-napoca, 400006, Romania|Ploiesti, 100163, Romania|Ploiesti, 100342, Romania|Levice, 93405, Slovakia|Presov, 080 01, Slovakia|Samorin, 931 01, Slovakia|Trebisov, 07501, Slovakia|Trencin, 911 01, Slovakia|Cape Town, 7130, South Africa|Pretoria, 0002, South Africa|Bacarot Alicant, Alicante, 03114, Spain|Almeria, 04001, Spain|Sevilla, 41010, Spain|Valencia, 46014, Spain|Ljungby, 34182, Sweden|Stockholm, 14186, Sweden|Örebro, 701 85, Sweden|Basel, 4031, Switzerland|Geneve, 1211, Switzerland|Zürich, 8063, Switzerland|Taichung, 407, Taiwan|Taipei, 114, Taiwan|Taipei, 220, Taiwan|Taoyuan County, 333, Taiwan|Bangkok, 10330, Thailand|Songkla, 90112, Thailand|Istanbul, 34390, Turkey|Bexhill on Sea, TN39 4SP, United Kingdom|Crawley, RH10 7DX, United Kingdom|Glasgow, G46 8NY, United Kingdom|Hinckley, LE10 2SE, United Kingdom|Reading, RG7 3SQ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00754988