A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.
NCT ID: NCT00423501
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
PHASE2
306 participants
INTERVENTIONAL
2007-02-28
2007-11-30
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
DOUBLE
Study Groups
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1
taspoglutide
5mg sc weekly
2
taspoglutide
10mg sc weekly
3
taspoglutide
20mg sc weekly
4
taspoglutide
10mg sc every 2 weeks
5
taspoglutide
20mg sc every 2 weeks
6
Placebo
sc weekly
Interventions
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Placebo
sc weekly
taspoglutide
20mg sc weekly
taspoglutide
10mg sc every 2 weeks
taspoglutide
5mg sc weekly
taspoglutide
10mg sc weekly
taspoglutide
20mg sc every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes mellitus, with stable metformin treatment for \>=3 months;
* stable weight +/-10% for \>=3 months before screening.
Exclusion Criteria
* treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
* use of weight-lowering medications in the last 3 months;
* uncontrolled hypertension.
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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Washington D.C., District of Columbia, United States
Woodstock, Georgia, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Rochester, New York, United States
Portland, Oregon, United States
Dallas, Texas, United States
Midland, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Adelaide, , Australia
Camperdown, , Australia
Dimitrovgrad, , Bulgaria
Pleven, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Bad Lauterberg im Harz, , Germany
Berlin, , Germany
Görlitz, , Germany
Hanover, , Germany
Mainz, , Germany
Neuss, , Germany
Nuremberg, , Germany
Guatemala City, , Guatemala
Hong Kong, , Hong Kong
Riga, , Latvia
Kaunas, , Lithuania
Klaipėda, , Lithuania
Vilnius, , Lithuania
Guadalajara, , Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Pachuca, , Mexico
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Jud Covasna, , Romania
Mures, , Romania
Ploieşti, , Romania
Satu Mare, , Romania
Sibiu, , Romania
Countries
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References
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Nauck MA, Ratner RE, Kapitza C, Berria R, Boldrin M, Balena R. Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebo-controlled study. Diabetes Care. 2009 Jul;32(7):1237-43. doi: 10.2337/dc08-1961. Epub 2009 Apr 14.
Other Identifiers
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BC20688
Identifier Type: -
Identifier Source: org_study_id