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.
A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy
2 other identifiers
interventional
1,072
26 countries
205
Brief Summary
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 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 Nov 2008
Typical duration for phase_3 diabetes-mellitus-type-2
205 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2008
CompletedFirst Posted
Study publicly available on registry
September 18, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 29, 2016
July 1, 2016
2.1 years
September 17, 2008
July 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change from baseline in HbA1c
24 weeks
Secondary Outcomes (3)
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
Study Arms (3)
insulin glargine
ACTIVE COMPARATORinsulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment
taspoglutide 10 mg
EXPERIMENTALtaspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment
taspoglutide 10 mg/20 mg
EXPERIMENTALtaspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment
Interventions
Eligibility Criteria
You may qualify if:
- adult patients, 18-75 years of age;
- 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.
You may not qualify if:
- history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (210)
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Phoenix, Arizona, 85032, United States
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Searcy, Arkansas, 72143, United States
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Concord, California, 94520, United States
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Huntington Beach, California, 92648, United States
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Los Angeles, California, 90015, United States
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Los Angeles, California, 90025, United States
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Los Gatos, California, 95032, United States
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Roseville, California, 95661, United States
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San Diego, California, 92109, United States
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Santa Ana, California, 92705, United States
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Westlake Village, California, 91361, United States
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Washington D.C., District of Columbia, 20010, United States
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Green Cove Springs, Florida, 32043, United States
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Hialeah, Florida, 33013, United States
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Jacksonville, Florida, 32204, United States
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Jacksonville, Florida, 32216, United States
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Ormond Beach, Florida, 32174, United States
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Oviedo, Florida, 32765, United States
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Palm Harbor, Florida, 34684, United States
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Trinity, Florida, 34655, United States
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Zephyrhills, Florida, 33542, United States
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Atlanta, Georgia, 30338, United States
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Quincy, Illinois, 62301, United States
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Springfield, Illinois, 62704-1433, United States
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Avon, Indiana, 46123, United States
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Indianapolis, Indiana, 46260, United States
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Arkansas City, Kansas, 67005, United States
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Crestview Hills, Kentucky, 41017, United States
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Metairie, Louisiana, 70006, United States
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Sunset, Louisiana, 70584, United States
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Portland, Maine, 04101, United States
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North East, Maryland, 21901, United States
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Worchester, Massachusetts, 01605, United States
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Saint Claire Shores, Michigan, 48081, United States
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Jackson, Mississippi, 39216, United States
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Picayune, Mississippi, 39466, United States
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Springfield, Missouri, 65807, United States
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Grand Island, Nebraska, 68803, United States
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Omaha, Nebraska, 68105, United States
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Omaha, Nebraska, 68131, United States
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Henderson, Nevada, 89014, United States
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Blackwood, New Jersey, 08012, United States
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Cherry Hill, New Jersey, 08002, United States
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Moorestown, New Jersey, 08057, United States
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Toms River, New Jersey, 08753, United States
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Toms River, New Jersey, 08755, United States
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Albany, New York, 12206-1098, United States
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Flushing, New York, 11365, United States
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Mineola, New York, 11501, United States
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Asheville, North Carolina, 28803, United States
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Harrisburg, North Carolina, 28075, United States
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Fargo, North Dakota, 58103, United States
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Centerville, Ohio, 45459, United States
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Cincinnati, Ohio, 45242, United States
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Genoa, Ohio, 43430-1143, United States
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Toledo, Ohio, 43606, United States
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Altoona, Pennsylvania, 16602, United States
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Bensalem, Pennsylvania, 19020, United States
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Feasterville, Pennsylvania, 19053, United States
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Harrisburg, Pennsylvania, 17112, United States
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Jefferson Hills, Pennsylvania, 15025, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19146, United States
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Scranton, Pennsylvania, 18510, United States
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Tipton, Pennsylvania, 16684, United States
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Orangeburg, South Carolina, 29115, United States
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Johnson City, Tennessee, 37604, United States
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Dallas, Texas, 75230, United States
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Dallas, Texas, 75246, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77030, United States
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Richmond, Virginia, 23249, United States
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Waukesha, Wisconsin, 53189, United States
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St Leonards, New South Wales, 2065, Australia
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Wollongong, New South Wales, 2500, Australia
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Freemantle, Queensland, 6959, Australia
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Graz, 8036, Austria
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Salzburg, 5020, Austria
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Vienna, 1030, Austria
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Vienna, 1080, Austria
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Vienna, 1130, Austria
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Arlon, 6700, Belgium
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Bonheiden, 2820, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Campina Grande do Sul, Paraná, 83430-000, Brazil
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Curitiba, Paraná, 80030-110, Brazil
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Recife, Pernambuco, 52051-380, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-170, 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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Hamilton, Ontario, L8S 4J9, Canada
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London, Ontario, N6A 5R8, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Pointe-Claire, Quebec, H9R 4S3, Canada
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Sherbrooke, Quebec, J1G 5K2, Canada
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Brno, 625 00, Czechia
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Havířov, 76301, Czechia
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Pilsen, 301 00, Czechia
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Prague, 180 00, Czechia
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Trutnov, 541 01, Czechia
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Helsinki, 00150, Finland
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Jyväskylä, 40100, Finland
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Tampere, 33100, Finland
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Avignon, 84902, France
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Besançon, 25030, France
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Bois-Guillaume, 76233, France
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Brest, 29609, France
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Corbeil-Essonnes, 91106, France
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La Rochelle, 17019, France
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Marseille, 13015, France
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Marseille, 13385, France
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Montpellier, 34295, France
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Nîmes, 30029, France
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Paris, 75651, France
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Paris, 75877, France
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Paris, 75908, France
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Strasbourg, 67091, France
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Vénissieux, 69200, France
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Bad Lauterberg im Harz, 37431, Germany
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Berlin, 10115, Germany
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Bochum, 44869, Germany
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Bosenheim, 55545, Germany
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Dortmund, 44137, Germany
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Falkensee, 14612, Germany
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Freiburg im Breisgau, 79106, Germany
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Mainz, 55116, Germany
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Offenbach a.M., 63065, Germany
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Reichenbach, 08468, Germany
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Würzburg, 97072, Germany
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Athens, 10552, Greece
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Larissa, 41110, Greece
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Thessaloniki, 56429, Greece
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Guatemala City, 01010, Guatemala
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Hong Kong, Hong Kong
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Balatonfüred, 8230, Hungary
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Budapest, 1045, Hungary
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Szekszárd, 7100, Hungary
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Napoli, Campania, 80100, Italy
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Rome, Lazio, 00157, Italy
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Codogno, Lombardy, 26845, Italy
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Milan, Lombardy, 20132, Italy
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Milan, Lombardy, 20142, Italy
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Turin, Piedmont, 10126, Italy
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Aguascalientes, 20127, Mexico
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Cuernavaca, 62250, Mexico
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Monterrey, 64410, 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, Lima 1, Peru
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Lima, Lima 33, Peru
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Trujillo, 13011, Peru
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Grodzisk Mazowiecki, 05-825, Poland
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Kamieniec Ząbkowicki, 57-230, Poland
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Lodz, 93-338, Poland
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Rzeszów, 35-073, Poland
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Sobótka, 55-050, Poland
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Szczecin, 71-455, Poland
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Wroclaw, 51-124, Poland
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Coimbra, 3000-075, Portugal
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Lisbon, 1250-203, Portugal
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Lisbon, 1349-019, Portugal
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Guyanabo, San Juan, 00920, Puerto Rico
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Levittown, 00950, Puerto Rico
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Orocovis, 00720, Puerto Rico
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Ponce, 00717-322, Puerto Rico
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San Juan, 00926-2832, Puerto Rico
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Trujillo Alto, 00976, Puerto Rico
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Barnaul, 656024, Russia
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Chelyabinsk, 454136, Russia
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Moscow, 117049, Russia
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Moscow, 125299, 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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Omsk, 644021, 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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Tomsk, 643050, Russia
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Belgrade, 11000, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Novi Sad, 21000, Serbia
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Daegu, 700-721, South Korea
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Incheon, South Korea
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Seoul, 137-040, South Korea
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Almería, Almeria, 04001, Spain
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Barcelona, Barcelona, 08025, Spain
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Granada, Granada, 18012, Spain
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Pozuelo de Alarcón, Madrid, 28223, Spain
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Seville, Sevilla, 41010, Spain
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Seville, Sevilla, 41013, Spain
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Alzira, Valencia, 46600, Spain
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Valencia, Valencia, 46010, Spain
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Valencia, Valencia, 46014, Spain
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Valladolid, Valladolid, 47005, Spain
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Atherstone, CV9 1EU, United Kingdom
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Chesterfield, S40 4TF, United Kingdom
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Dumfries, DG1 4AP, United Kingdom
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Liverpool, L9 7AL, United Kingdom
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Sheffield, S18 1RU, United Kingdom
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Trowbridge, BA14 8QA, United Kingdom
Related Publications (1)
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.
PMID: 22937895DERIVED
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
September 17, 2008
First Posted
September 18, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
July 29, 2016
Record last verified: 2016-07