A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus
2 other identifiers
interventional
1,189
26 countries
216
Brief Summary
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is \>500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Jul 2008
Longer than P75 for phase_3 diabetes-mellitus-type-2
216 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedNovember 2, 2016
November 1, 2016
2.7 years
July 16, 2008
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
24 weeks
Secondary Outcomes (4)
Fasting body weight
24 weeks
Proportion of patients reaching target HbA1c <=7.0%, <=6.5%
24 weeks
Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.
24 weeks
Beta cell function (proinsulin/insulin ratio)
24 weeks
Study Arms (3)
exenatide
ACTIVE COMPARATORtaspoglutide 10mg
EXPERIMENTALtaspoglutide 10mg/20mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, 18-75 years of age;
- type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
- HbA1c \>=7.0% and \<=10% at screening;
- BMI \>=25kg/m2 (\>23kg/m2 for Asians) and \<=45kg/m2 at screening;
- stable weight +/- 5% for at least 12 weeks prior to screening.
You may not qualify if:
- history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
- history of acute metabolic diabetic complications within the previous 6 months;
- evidence of clinically significant diabetic complications;
- known proliferative diabetic retinopathy;
- myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
- any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
- known hemoglobinopathy or chronic anemia;
- clinically significant gastrointestinal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (216)
Unknown Facility
Haleyville, Alabama, 35565, United States
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Mobile, Alabama, 36617, United States
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Montgomery, Alabama, 36106, United States
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Tuscaloosa, Alabama, 35406, United States
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Little Rock, Arkansas, 72204, United States
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Escondido, California, 92026, United States
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La Jolla, California, 92037, United States
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Mission Viejo, California, 92691, United States
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Orange, California, 92868, United States
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Palm Springs, California, 92262, United States
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Rancho Cucamonga, California, 91730, United States
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Sacramento, California, 95816-5119, United States
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San Leandro, California, 94578, United States
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Colorado Springs, Colorado, 80904, United States
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Daytona Beach, Florida, 32114, United States
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Fort Lauderdale, Florida, 33316, United States
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Green Cove Springs, Florida, 32043, United States
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Jacksonville, Florida, 32216, United States
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Miami Beach, Florida, 33140, United States
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Niceville, Florida, 32578, United States
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Orlando, Florida, 32804, United States
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Atlanta, Georgia, 30308, United States
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Atlanta, Georgia, 30318, United States
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Suwanee, Georgia, 30024, United States
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Chicago, Illinois, 60607, United States
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Chicago, Illinois, 60622, United States
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Lombard, Illinois, 60148, United States
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Peoria, Illinois, 61625, United States
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Evansville, Indiana, 47714, United States
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New Albany, Indiana, 47150, United States
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Iowa City, Iowa, 52242, United States
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Munfordville, Kentucky, 42765, United States
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Metairie, Louisiana, 70006, United States
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Bangor, Maine, 04401, United States
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Baltimore, Maryland, 21209, United States
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Bethesda, Maryland, 20817, United States
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Rockville, Maryland, 20854, United States
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Royal Oak, Michigan, 48073, United States
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Jefferson City, Missouri, 65109, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, 63141, United States
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Washington, Missouri, 63090, United States
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Omaha, Nebraska, 68114, United States
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Concord, New Hampshire, 03301, United States
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Trenton, New Jersey, 08611, United States
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Voorhees Township, New Jersey, 08043, United States
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Whitehouse, New Jersey, 08889, United States
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Brooklyn, New York, 11203, United States
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New York, New York, 10025, United States
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Rochester, New York, 14607, United States
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Smithtown, New York, 11787, United States
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Springfield Gardens, New York, 11413, United States
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Staten Island, New York, 10301, United States
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Syracuse, New York, 13210, United States
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West Seneca, New York, 14224, United States
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Westfield, New York, 14787, United States
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Charlotte, North Carolina, 28209, United States
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Charlotte, North Carolina, 28233, United States
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Durham, North Carolina, 27713, United States
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Greensboro, North Carolina, 27408, United States
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Huntersville, North Carolina, 28078, United States
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Salisbury, North Carolina, 28144, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58103, United States
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Cincinnati, Ohio, 45236, United States
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Columbus, Ohio, 43212, United States
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Westlake, Ohio, 44145, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97239, United States
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Altoona, Pennsylvania, 16602, United States
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Norristown, Pennsylvania, 19401, United States
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Philadelphia, Pennsylvania, 19107, United States
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Red Lion, Pennsylvania, 17356, United States
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Providence, Rhode Island, 02908, United States
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Clemson, South Carolina, 29631, United States
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Columbia, South Carolina, 29201, United States
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Hickory Grove, South Carolina, 28602, United States
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Simpsonville, South Carolina, 29681, United States
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Bristol, Tennessee, 37620, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75230, United States
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Houston, Texas, 77005, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77074, United States
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Richmond, Virginia, 23226, United States
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Everett, Washington, 98201, United States
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Buenos Aires, 6000, Argentina
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Buenos Aires, C1117ABH, Argentina
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Buenos Aires, C1181ACH, Argentina
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Camperdown, New South Wales, 2050, Australia
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Freemantle, Queensland, 6959, Australia
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Goiânia, Goiás, 74043011, Brazil
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Curtiba, Paraná, 80030-110, Brazil
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Belém, Pará, 66073-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-170, Brazil
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Mogi Das Cruzes - Sp, São Paulo, 08780-090, Brazil
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São Paulo, São Paulo, 01221-020, Brazil
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São Paulo, São Paulo, 04022-001, Brazil
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Vancouver, British Columbia, V5Z 1L8, Canada
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London, Ontario, N6A 5R8, Canada
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Toronto, Ontario, M5C 2T2, Canada
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Pointe-Claire, Quebec, H9R 4S3, Canada
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Ballerup Municipality, 2750, Denmark
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Helsinki, 00150, Finland
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Kuopio, 70210, Finland
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Oulu, 90100, Finland
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Turku, 20100, Finland
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Corbeil-Essonnes, 91106, France
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Dommartin-lès-Toul, 54200, France
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Montpellier, 34295, France
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Narbonne, 11108, France
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Paris, 75475, France
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Salouël, 80480, France
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Aschaffenburg, 63739, Germany
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Berlin, 10115, Germany
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Damme, 49401, Germany
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Dresden, 01219, Germany
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Essen, 45359, Germany
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Falkensee, 14612, Germany
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Hamburg, 21073, Germany
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Hamburg, 22607, Germany
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Ludwigshafen, 67059, Germany
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Mainz, 55116, Germany
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München, 80634, Germany
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Münster, 48145, Germany
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Neuwied, 56564, Germany
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Nuremberg, 90402, Germany
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Pirna, 01796, Germany
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Rhaunen, 55624, Germany
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Villingen-Schwenningen, 78048, Germany
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Zwenkau, 04442, Germany
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Thessaloniki, 56429, Greece
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Thessaloniki, 57010, Greece
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Guatemala City, 01000, Guatemala
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Guatemala City, 01014, Guatemala
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Beersheba, 8410101, Israel
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Haifa, 31096, Israel
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Holon, 58100, Israel
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Jerusalem, 91200, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Pordenone, Friuli Venezia Giulia, 33170, Italy
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Genoa, Liguria, 16132, Italy
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Pavia, Lombardy, 27100, Italy
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Olbia, Sardinia, 07026, Italy
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Siena, Tuscany, 53100, Italy
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Acapulco, 39670, Mexico
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Aguascalientes, 20127, Mexico
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Chihuahua City, 31205, Mexico
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Durango, 34000, Mexico
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Guadalajara, 44600, Mexico
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Guadalajara, 44650, Mexico
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Monterrey, 64460, Mexico
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Monterrey, 64700, Mexico
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Tampico, 89000, Mexico
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Auckland, 1640, New Zealand
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Auckland, New Zealand
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Arequipa, Cercado, Peru
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Lima, 41, Peru
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Lima, Lima 33, Peru
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Ponce, 00716, Puerto Rico
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Ponce, 00717-322, Puerto Rico
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Barnaul, 656024, Russia
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Moscow, 109263, Russia
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Moscow, 119048, Russia
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Moscow, 119121, Russia
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Moscow, 121069, Russia
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Moscow, 125299, Russia
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Moscow, 125315, Russia
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Moscow, 129110, Russia
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Nizhny Novgorod, 603126, Russia
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Novosibirsk, 630047, Russia
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Novosibirsk, 630091, Russia
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Omsk, 644021, Russia
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S. Petersburg, 194291, Russia
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S.Petersburg, 194017, Russia
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Saint Petersburg, 191124, Russia
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Saint Petersburg, 193012, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 195213, Russia
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Saint Petersburg, 197022, Russia
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Saratov, 140018, Russia
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Tomsk, 643050, Russia
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Yaroslavl, 150010, Russia
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Yaroslavl, 150062, Russia
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Cape Town, 7130, South Africa
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Pretoria, 0002, South Africa
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Seoul, 0, South Korea
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Seoul, 110-744, South Korea
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Bacarot Alicant, Alicante, 03114, Spain
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Almería, Almeria, 04001, Spain
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Madrid, Madrid, 28041, Spain
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Alzira, Valencia, 46600, Spain
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Karlstad, 65185, Sweden
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Örebro, 701 85, Sweden
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Stockholm, 171 76, Sweden
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Uppsala, 75185, Sweden
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Zurich, 8091, Switzerland
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Dnipro, 49044, Ukraine
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Donetsk, 83003, Ukraine
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Kiev, 02091, Ukraine
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Lviv, 79010, Ukraine
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Odesa, 65009, Ukraine
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Odesa, 65117, Ukraine
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Simferopol, 95017, Ukraine
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Bath, BA1 2SR, United Kingdom
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Bradford-on-Avon, BA15 1DQ, United Kingdom
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Glasgow, G45 9AW, United Kingdom
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Lanarkshire, ML1 3JX, United Kingdom
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Trowbridge, BA14 8QA, United Kingdom
Related Publications (1)
Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.
PMID: 23139373DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2008
First Posted
July 17, 2008
Study Start
July 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
November 2, 2016
Record last verified: 2016-11