A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.
NCT ID: NCT00460941
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
133 participants
INTERVENTIONAL
2007-04-30
2008-01-31
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
DOUBLE
Study Groups
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Placebo
sc weekly
Placebo
sc weekly
Taspoglutide 20mg
sc weekly
Taspoglutide 20mg
sc weekly
Taspoglutide 20mg-30mg
sc weekly
Taspoglutide 20mg-30mg
sc weekly
Taspoglutide 20mg-40mg
sc weekly
Taspoglutide 20mg-40mg
sc weekly
Interventions
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Placebo
sc weekly
Taspoglutide 20mg
sc weekly
Taspoglutide 20mg-30mg
sc weekly
Taspoglutide 20mg-40mg
sc weekly
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes mellitus, with stable metformin treatment for \>=3 months;
* HbA1c \>=7.0% and \<=9.5% at screening;
* stable weight +/-10% for \>=3 months before screening.
Exclusion Criteria
* clinically significant gastrointestinal disease;
* 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;
* previous exposure to GLP-1 or GLP-1 analogues.
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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Harrisburg, Arkansas, United States
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
National City, California, United States
Jacksonville, Florida, United States
Madisonville, Kentucky, United States
Hyattsville, Maryland, United States
Winston-Salem, North Carolina, United States
Dallas, Texas, United States
Dallas, Texas, United States
Richmond, Virginia, United States
Adelaide, , Australia
Camperdown, , Australia
Besançon, , France
Corbeil-Essonnes, , France
Narbonne, , France
Paris, , France
Poitiers, , France
Berlin, , Germany
München, , Germany
Neuss, , Germany
Chihuahua City, , Mexico
Culiacán, , Mexico
Monterrey, , Mexico
Tampico, , Mexico
Lima, , Peru
Lima, , Peru
Lima, , Peru
Ponce, , Puerto Rico
Countries
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References
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Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R. Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. Diabet Med. 2010 May;27(5):556-62. doi: 10.1111/j.1464-5491.2010.02990.x.
Other Identifiers
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BC20728
Identifier Type: -
Identifier Source: org_study_id