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.
NCT ID: NCT00755287
Last Updated: 2016-07-29
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
1072 participants
INTERVENTIONAL
2008-11-30
2010-12-31
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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insulin glargine
insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment
insulin glargine
starting dose 10 IU daily
metformin
As prescribed
taspoglutide 10 mg
taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment
metformin
As prescribed
taspoglutide
10 mg once weekly
taspoglutide 10 mg/20 mg
taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment
metformin
As prescribed
taspoglutide
20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)
Interventions
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insulin glargine
starting dose 10 IU daily
metformin
As prescribed
taspoglutide
10 mg once weekly
taspoglutide
20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
* C-peptide (fasting) \>=1.0ng/mL;
* HbA1c \>=7.0% and \<=10.0% at screening;
* BMI \>=25 (\>23 for Asians) and \<=45kg/m2 at screening;
* stable weight +-5% for at least 12 weeks prior to screening.
Exclusion Criteria
* evidence of clinically significant diabetic complications;
* symptomatic poorly controlled diabetes;
* clinically symptomatic gastrointestinal disease;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
* known hemoglobinopathy or chronic anemia.
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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Phoenix, Arizona, United States
Searcy, Arkansas, United States
Concord, California, United States
Huntington Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
Roseville, California, United States
San Diego, California, United States
Santa Ana, California, United States
Westlake Village, California, United States
Washington D.C., District of Columbia, United States
Green Cove Springs, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Ormond Beach, Florida, United States
Oviedo, Florida, United States
Palm Harbor, Florida, United States
Trinity, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Quincy, Illinois, United States
Springfield, Illinois, United States
Avon, Indiana, United States
Indianapolis, Indiana, United States
Arkansas City, Kansas, United States
Crestview Hills, Kentucky, United States
Metairie, Louisiana, United States
Sunset, Louisiana, United States
Portland, Maine, United States
North East, Maryland, United States
Worchester, Massachusetts, United States
Saint Claire Shores, Michigan, United States
Jackson, Mississippi, United States
Picayune, Mississippi, United States
Springfield, Missouri, United States
Grand Island, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Blackwood, New Jersey, United States
Cherry Hill, New Jersey, United States
Moorestown, New Jersey, United States
Toms River, New Jersey, United States
Toms River, New Jersey, United States
Albany, New York, United States
Flushing, New York, United States
Mineola, New York, United States
Asheville, North Carolina, United States
Harrisburg, North Carolina, United States
Fargo, North Dakota, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Genoa, Ohio, United States
Toledo, Ohio, United States
Altoona, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Feasterville, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
Jefferson Hills, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Scranton, Pennsylvania, United States
Tipton, Pennsylvania, United States
Orangeburg, South Carolina, United States
Johnson City, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Waukesha, Wisconsin, United States
St Leonards, New South Wales, Australia
Wollongong, New South Wales, Australia
Freemantle, Queensland, Australia
Graz, , Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Arlon, , Belgium
Bonheiden, , Belgium
Leuven, , Belgium
Liège, , Belgium
Campina Grande do Sul, Paraná, Brazil
Curitiba, Paraná, Brazil
Recife, Pernambuco, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Pointe-Claire, Quebec, Canada
Sherbrooke, Quebec, Canada
Brno, , Czechia
Havířov, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Trutnov, , Czechia
Helsinki, , Finland
Jyväskylä, , Finland
Tampere, , Finland
Avignon, , France
Besançon, , France
Bois-Guillaume, , France
Brest, , France
Corbeil-Essonnes, , France
La Rochelle, , France
Marseille, , France
Marseille, , France
Montpellier, , France
Nîmes, , France
Paris, , France
Paris, , France
Paris, , France
Strasbourg, , France
Vénissieux, , France
Bad Lauterberg im Harz, , Germany
Berlin, , Germany
Bochum, , Germany
Bosenheim, , Germany
Dortmund, , Germany
Falkensee, , Germany
Freiburg im Breisgau, , Germany
Mainz, , Germany
Offenbach a.M., , Germany
Reichenbach, , Germany
Würzburg, , Germany
Athens, , Greece
Larissa, , Greece
Thessaloniki, , Greece
Guatemala City, , Guatemala
Hong Kong, , Hong Kong
Balatonfüred, , Hungary
Budapest, , Hungary
Szekszárd, , Hungary
Napoli, Campania, Italy
Rome, Lazio, Italy
Codogno, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Turin, Piedmont, Italy
Aguascalientes, , Mexico
Cuernavaca, , Mexico
Monterrey, , Mexico
Tampico, , Mexico
Auckland, , New Zealand
Auckland, , New Zealand
Arequipa, , Peru
Lima, , Peru
Lima, , Peru
Trujillo, , Peru
Grodzisk Mazowiecki, , Poland
Kamieniec Ząbkowicki, , Poland
Lodz, , Poland
Rzeszów, , Poland
Sobótka, , Poland
Szczecin, , Poland
Wroclaw, , Poland
Coimbra, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Guyanabo, San Juan, , Puerto Rico
Levittown, , Puerto Rico
Orocovis, , Puerto Rico
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Trujillo Alto, , Puerto Rico
Barnaul, , Russia
Chelyabinsk, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Tomsk, , Russia
Belgrade, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Novi Sad, , Serbia
Daegu, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Almería, Almeria, Spain
Barcelona, Barcelona, Spain
Granada, Granada, Spain
Pozuelo de Alarcón, Madrid, Spain
Seville, Sevilla, Spain
Seville, Sevilla, Spain
Alzira, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Valladolid, Valladolid, Spain
Bangkok, , Thailand
Bangkok, , Thailand
Atherstone, , United Kingdom
Chesterfield, , United Kingdom
Dumfries, , United Kingdom
Liverpool, , United Kingdom
Sheffield, , United Kingdom
Trowbridge, , United Kingdom
Countries
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References
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Nauck M, Horton E, Andjelkovic M, Ampudia-Blasco FJ, Parusel CT, Boldrin M, Balena R; T-emerge 5 Study Group. Taspoglutide, a once-weekly glucagon-like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: an open-label randomized trial. Diabet Med. 2013 Jan;30(1):109-13. doi: 10.1111/dme.12003.
Other Identifiers
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2008-001855-23
Identifier Type: -
Identifier Source: secondary_id
BC20965
Identifier Type: -
Identifier Source: org_study_id
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