A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
NCT ID: NCT00754988
Last Updated: 2016-11-04
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
666 participants
INTERVENTIONAL
2008-10-31
2011-03-31
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
Once daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Metformin
As prescribed
Placebo (matching sitagliptin)
Once daily oral administration of placebo (matching sitagliptin).
Placebo (matching taspoglutide)
Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).
Sitagliptin
Once daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Metformin
As prescribed
Placebo (matching taspoglutide)
Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).
Sitagliptin
Once daily oral administration of 100 mg of sitagliptin.
Taspoglutide 10 mg
Once weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
Metformin
As prescribed
Placebo (matching sitagliptin)
Once daily oral administration of placebo (matching sitagliptin).
Taspoglutide
Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.
Taspoglutide up-titrated to 20 mg
Once weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
Metformin
As prescribed
Placebo (matching sitagliptin)
Once daily oral administration of placebo (matching sitagliptin).
Taspoglutide
Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.
Interventions
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Metformin
As prescribed
Placebo (matching sitagliptin)
Once daily oral administration of placebo (matching sitagliptin).
Placebo (matching taspoglutide)
Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).
Sitagliptin
Once daily oral administration of 100 mg of sitagliptin.
Taspoglutide
Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes receiving metformin (\>=1500mg/day) for at least 12 weeks;
* 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;
* 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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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Tallassee, Alabama, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Huntington Beach, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Roseville, California, United States
San Francisco, California, United States
Tacoma, California, United States
Colorado Springs, Colorado, United States
New London, Connecticut, United States
Manati, District of Columbia, United States
Daytona Beach, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Panama City, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Conyers, Georgia, United States
Snellville, Georgia, United States
Honolulu, Hawaii, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Lafayette, Indiana, United States
South Bend, Indiana, United States
Baltimore, Maryland, United States
Brockton, Massachusetts, United States
Cadillac, Michigan, United States
Brooklyn Center, Minnesota, United States
Minneapolis, Minnesota, United States
City of Saint Peters, Missouri, United States
Fulton, New York, United States
Hudson, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Shelby, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Delaware, Ohio, United States
Marion, Ohio, United States
Corvallis, Oregon, United States
Eugene, Oregon, United States
Aliquippa, Pennsylvania, United States
Beaver, Pennsylvania, United States
Erie, Pennsylvania, United States
Reading, Pennsylvania, United States
Reading, Pennsylvania, United States
Shippensburg, Pennsylvania, United States
Warminster, Pennsylvania, United States
Anderson, South Carolina, United States
Kingsport, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
South Burlington, Vermont, United States
Hampton, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Federal Way, Washington, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Mar del Plata, , Argentina
Freemantle, Queensland, Australia
Adelaide, South Australia, Australia
London, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Bondy, , France
Nantes, , France
Poitiers, , France
Rennes, , France
Saint-Mandé, , France
Berlin, , Germany
Dormagen, , Germany
Dresden, , Germany
Kiel Kronshagen, , Germany
München, , Germany
Sulzbach-Rosenberg, , Germany
Villingen-Schwenningen, , Germany
Larissa, , Greece
Cuernavaca, , Mexico
Hermosillo, , Mexico
Jalisco, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Pachuca, , Mexico
Elverum, , Norway
Oslo, , Norway
Oslo, , Norway
Oslo, , Norway
Lima, , Peru
Lima, , Peru
Bialystok, , Poland
Gdansk, , Poland
Kamieniec Ząbkowicki, , Poland
Rzeszów, , Poland
Skierniewice, , Poland
Sobótka, , Poland
Wroclaw, , Poland
Caguas, , Puerto Rico
Carolina, , Puerto Rico
Bucharest, , Romania
Buzău, , Romania
Cluj-Napoca, , Romania
Ploieşti, , Romania
Ploieşti, , Romania
Levice, , Slovakia
Prešov, , Slovakia
Šamorín, , Slovakia
Trebišov, , Slovakia
Trenčín, , Slovakia
Cape Town, , South Africa
Pretoria, , South Africa
Gyeonggi-do, , South Korea
Gyeonggi-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Wŏnju, , South Korea
Bacarot Alicant, Alicante, Spain
Almería, Almeria, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain
Ljungby, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Basel, , Switzerland
Geneva, , Switzerland
Zurich, , Switzerland
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Bangkok, , Thailand
Songkhla, , Thailand
Istanbul, , Turkey (Türkiye)
Bexhill-on-Sea, , United Kingdom
Crawley, , United Kingdom
Glasgow, , United Kingdom
Hinckley, , United Kingdom
Reading, , United Kingdom
Countries
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Other Identifiers
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2008-001854-42
Identifier Type: -
Identifier Source: secondary_id
BC21713
Identifier Type: -
Identifier Source: org_study_id