A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
NCT ID: NCT00823992
Last Updated: 2016-07-28
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
305 participants
INTERVENTIONAL
2009-01-31
2010-05-31
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
placebo
sc once weekly
taspoglutide
taspoglutide
10mg sc once weekly for 4 weeks, then 20mg sc once weekly
Interventions
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placebo
sc once weekly
taspoglutide
10mg sc once weekly for 4 weeks, then 20mg sc once weekly
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes mellitus, receiving metformin at a stable dose of \>=1500mg/day for at least 12 weeks;
* HbA1c \>=6.5% and \<=9.5% at screening;
* BMI \>=30 and \<=50 kg/m2 at screening;
* stable weight +/-5% for at least 12 weeks prior to screening.
Exclusion Criteria
* evidence of clinically significant diabetic complications;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.
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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Bermuda Dunes, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Brooksville, Florida, United States
Miami, Florida, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Avon, Indiana, United States
New Orleans, Louisiana, United States
Bangor, Maine, United States
Royal Oak, Michigan, United States
Picayune, Mississippi, United States
Clifton, New Jersey, United States
Toms River, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Springfield Gardens, New York, United States
Charlotte, North Carolina, United States
Shelby, North Carolina, United States
Norman, Oklahoma, United States
Medford, Oregon, United States
Clinton, South Carolina, United States
Kingsport, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Midland, Texas, United States
San Antonio, Texas, United States
Vancouver, British Columbia, Canada
Sherbrooke, Nova Scotia, Canada
Etobicoke, Ontario, Canada
Hamilton, Ontario, Canada
Oakville, Ontario, Canada
Toronto, Ontario, Canada
Aschaffenburg, , Germany
Berlin, , Germany
Bochum, , Germany
Dortmund, , Germany
Dresden, , Germany
Falkensee, , Germany
Mainz, , Germany
Münster, , Germany
Neuwied, , Germany
Ancona, , Italy
Ravenna, , Italy
Roma, , Italy
Siena, , Italy
Bitola, , North Macedonia
Gniewkowo, , Poland
Kamieniec Ząbkowicki, , Poland
Lublin, , Poland
Carolina, , Puerto Rico
Rio Piedras, , Puerto Rico
Río Grande, , Puerto Rico
Kemerovo, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Ryazan, , Russia
Saratov, , Russia
Smolensk, , Russia
Tyumen, , Russia
Barcelona, , Spain
Lleida, , Spain
Oviedo, , Spain
Bath, , United Kingdom
Birmingham, , United Kingdom
Glasgow, , United Kingdom
Midsomer Norton, , United Kingdom
Rotherham, , United Kingdom
Countries
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Other Identifiers
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2008-005809-20
Identifier Type: -
Identifier Source: secondary_id
BC22092
Identifier Type: -
Identifier Source: org_study_id
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