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.
NCT ID: NCT00717457
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1189 participants
INTERVENTIONAL
2008-07-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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exenatide
exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily
taspoglutide 10mg
taspoglutide
10mg once weekly
taspoglutide 10mg/20mg
taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly
Interventions
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exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily
taspoglutide
10mg once weekly
taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Haleyville, Alabama, United States
Mobile, Alabama, United States
Montgomery, Alabama, United States
Tuscaloosa, Alabama, United States
Little Rock, Arkansas, United States
Escondido, California, United States
La Jolla, California, United States
Mission Viejo, California, United States
Orange, California, United States
Palm Springs, California, United States
Rancho Cucamonga, California, United States
Sacramento, California, United States
San Leandro, California, United States
Colorado Springs, Colorado, United States
Daytona Beach, Florida, United States
Fort Lauderdale, Florida, United States
Green Cove Springs, Florida, United States
Jacksonville, Florida, United States
Miami Beach, Florida, United States
Niceville, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Suwanee, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Lombard, Illinois, United States
Peoria, Illinois, United States
Evansville, Indiana, United States
New Albany, Indiana, United States
Iowa City, Iowa, United States
Munfordville, Kentucky, United States
Metairie, Louisiana, United States
Bangor, Maine, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Rockville, Maryland, United States
Royal Oak, Michigan, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Washington, Missouri, United States
Omaha, Nebraska, United States
Concord, New Hampshire, United States
Trenton, New Jersey, United States
Voorhees Township, New Jersey, United States
Whitehouse, New Jersey, United States
Brooklyn, New York, United States
New York, New York, United States
Rochester, New York, United States
Smithtown, New York, United States
Springfield Gardens, New York, United States
Staten Island, New York, United States
Syracuse, New York, United States
West Seneca, New York, United States
Westfield, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Huntersville, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Westlake, Ohio, United States
Medford, Oregon, United States
Portland, Oregon, United States
Altoona, Pennsylvania, United States
Norristown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Red Lion, Pennsylvania, United States
Providence, Rhode Island, United States
Clemson, South Carolina, United States
Columbia, South Carolina, United States
Hickory Grove, South Carolina, United States
Simpsonville, South Carolina, United States
Bristol, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Everett, Washington, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Camperdown, New South Wales, Australia
Freemantle, Queensland, Australia
Goiânia, Goiás, Brazil
Curtiba, Paraná, Brazil
Belém, Pará, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Mogi Das Cruzes - Sp, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Vancouver, British Columbia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Pointe-Claire, Quebec, Canada
Ballerup Municipality, , Denmark
Helsinki, , Finland
Kuopio, , Finland
Oulu, , Finland
Turku, , Finland
Corbeil-Essonnes, , France
Dommartin-lès-Toul, , France
Montpellier, , France
Narbonne, , France
Paris, , France
Salouël, , France
Aschaffenburg, , Germany
Berlin, , Germany
Damme, , Germany
Dresden, , Germany
Essen, , Germany
Falkensee, , Germany
Hamburg, , Germany
Hamburg, , Germany
Ludwigshafen, , Germany
Mainz, , Germany
München, , Germany
Münster, , Germany
Neuwied, , Germany
Nuremberg, , Germany
Pirna, , Germany
Rhaunen, , Germany
Villingen-Schwenningen, , Germany
Zwenkau, , Germany
Thessaloniki, , Greece
Thessaloniki, , Greece
Guatemala City, , Guatemala
Guatemala City, , Guatemala
Beersheba, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Pordenone, Friuli Venezia Giulia, Italy
Genoa, Liguria, Italy
Pavia, Lombardy, Italy
Olbia, Sardinia, Italy
Siena, Tuscany, Italy
Acapulco, , Mexico
Aguascalientes, , Mexico
Chihuahua City, , Mexico
Durango, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Tampico, , Mexico
Auckland, , New Zealand
Auckland, , New Zealand
Arequipa, , Peru
Lima, , Peru
Lima, , Peru
Ponce, , Puerto Rico
Ponce, , Puerto Rico
Barnaul, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Omsk, , Russia
S. Petersburg, , Russia
S.Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Tomsk, , Russia
Yaroslavl, , Russia
Yaroslavl, , Russia
Cape Town, , South Africa
Pretoria, , South Africa
Seoul, , South Korea
Seoul, , South Korea
Bacarot Alicant, Alicante, Spain
Almería, Almeria, Spain
Madrid, Madrid, Spain
Alzira, Valencia, Spain
Karlstad, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Zurich, , Switzerland
Bangkok, , Thailand
Bangkok, , Thailand
Dnipro, , Ukraine
Donetsk, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Odesa, , Ukraine
Simferopol, , Ukraine
Bath, , United Kingdom
Bradford-on-Avon, , United Kingdom
Glasgow, , United Kingdom
Lanarkshire, , United Kingdom
Trowbridge, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2008-001856-36
Identifier Type: -
Identifier Source: secondary_id
BC21625
Identifier Type: -
Identifier Source: org_study_id