A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
NCT ID: NCT01018173
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2118 participants
INTERVENTIONAL
2010-01-31
2011-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
placebo
placebo
sc weekly
taspoglutide
taspoglutide
10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
placebo
sc weekly
taspoglutide
10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* diabetes mellitus type 2
* HbA1c \>/=6.5% and \</=10% at screening
* BMI \>/=23kg/m2
* cardiovascular disease with onset \>/=1 month prior to screening
Exclusion Criteria
* acute metabolic diabetic complications within past 6 months
* severe hypoglycemia \</=1 month prior to screening
* clinically significant gastrointestinal disease
* history of chronic or acute pancreatitis
* current New York Heart Association (NYHA) class IV heart failure or post-transplantation cardiomyopathy
* severely impaired renal function
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Tucson, Arizona, United States
Buena Park, California, United States
Calabasas, California, United States
Fresno, California, United States
Santa Ana, California, United States
Walnut Creek, California, United States
Centennial, Colorado, United States
Colorado Springs, Colorado, United States
Trumbull, Connecticut, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
Delray Beach, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Ponte Verde, Florida, United States
Bloomingdale, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
Baltimore, Maryland, United States
Oxon Hill, Maryland, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
North Platte, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Nashua, New Hampshire, United States
Toms River, New Jersey, United States
Mineola, New York, United States
New York, New York, United States
Calabash, North Carolina, United States
Cary, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Mooresville, North Carolina, United States
Raleigh, North Carolina, United States
Bismarck, North Dakota, United States
Bismarck, North Dakota, United States
Cleveland, Ohio, United States
Kettering, Ohio, United States
Toledo, Ohio, United States
Bend, Oregon, United States
Medford, Oregon, United States
Portland, Oregon, United States
Beaver, Pennsylvania, United States
Levittown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pottstown, Pennsylvania, United States
Greer, South Carolina, United States
Hickory Grove, South Carolina, United States
Bristol, Tennessee, United States
Johnson City, Tennessee, United States
Austin, Texas, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
North Richland Hills, Texas, United States
Richardson, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Burke, Virginia, United States
Hampton, Virginia, United States
Manassas, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Winchester, Virginia, United States
Tacoma, Washington, United States
Freemantle, Queensland, Australia
Herston, Queensland, Australia
Elizabeth Vale, South Australia, Australia
Melbourne, Victoria, Australia
Fortaleza, Ceará, Brazil
Fortaleza, Ceará, Brazil
Campina Grande do Sul, Paraná, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Byala, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Barrie, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Havířov, , Czechia
Jindřichův Hradec, , Czechia
Mariánské Lázně, , Czechia
Olomouc, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Rakovník, , Czechia
Ricany U Prahy, , Czechia
Semily, , Czechia
Trutnov, , Czechia
Uherské Hradiště, , Czechia
Ústí nad Labem, , Czechia
Aalborg, , Denmark
Ballerup Municipality, , Denmark
Hvidovre, , Denmark
Vejle, , Denmark
Paide, , Estonia
Saku, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Tartu, , Estonia
Viljandimaa, , Estonia
Võru, , Estonia
Bad Lauterberg im Harz, , Germany
Bad Oeynhausen, , Germany
Bochum, , Germany
Dortmund, , Germany
Dresden, , Germany
Essen, , Germany
Hamburg, , Germany
Kleve, , Germany
Neuss, , Germany
Nuremberg, , Germany
Wuppertal, , Germany
Balatonfüred, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Gyula, , Hungary
Hódmezővásárhely, , Hungary
Komárom, , Hungary
Makó, , Hungary
Sopron, , Hungary
Szikszó, , Hungary
Úrhida, , Hungary
Veszprém, , Hungary
Ahmedabad, , India
Aurangabad, , India
Bangalore, , India
Bangalore, , India
Bangalore, , India
Bangalore, , India
Banglore, , India
Bhopal, , India
Chennai, , India
Chennai, , India
Chennai, , India
Hyderabad, , India
Jaipur, , India
Kochi, , India
Kolkata, , India
Madurai, , India
Mangalore, , India
Mumbai, , India
Mumbai, , India
Nagpur, , India
Nagpur, , India
Pune, , India
Pune, , India
Pune, , India
Jerusalem, , Israel
Alytus, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Klaipėda, , Lithuania
Panevezys, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
George Town, , Malaysia
Johor Bahru, , Malaysia
Kelantan, , Malaysia
Aguascalientes, , Mexico
Chihuahua City, , Mexico
Cuernavaca, , Mexico
Culiacán, , Mexico
Durango, , Mexico
Juarez, Distrito Federal, , Mexico
Mexico City, , Mexico
México, , Mexico
Monterrey, , Mexico
Tampico, , Mexico
Gdansk, , Poland
Gdynia, , Poland
Kamieniec Ząbkowicki, , Poland
Katowice, , Poland
Kielce, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Poznan, , Poland
Płock, , Poland
Radom, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bacau, , Romania
Baia Mare, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Constanța, , Romania
Galati, , Romania
Oradea, , Romania
Ploieşti, , Romania
Ploieşti, , Romania
Târgu Mureş, , Romania
Timișoara, , Romania
Barnaul, , Russia
Kemerovo, , Russia
Moscow, , Russia
Novosibirsk, , Russia
S. Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Dolný Kubín, , Slovakia
Komárno, , Slovakia
Levice, , Slovakia
Levice, , Slovakia
Lučenec, , Slovakia
Prievidza, , Slovakia
Trenčín, , Slovakia
Cape Town, , South Africa
Cape Town, , South Africa
Durban, , South Africa
Johannesburg, , South Africa
Johannesburg, , South Africa
Observatory, Cape Town, , South Africa
Port Elizabeth, , South Africa
Pretoria, , South Africa
Pretoria, , South Africa
Richards Bay, , South Africa
Soweto, , South Africa
Soweto, , South Africa
Lugo, Lugo, Spain
Madrid, Madrid, Spain
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Kharkiv, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Mykolaiv, , Ukraine
Poltava, , Ukraine
Ternopil, , Ukraine
Vinnitsa, , Ukraine
Zaporizhzhya, , Ukraine
Zaporizhzhya, , Ukraine
Bexhill-on-Sea, , United Kingdom
Birmingham, , United Kingdom
Cardiff, , United Kingdom
Chorley, , United Kingdom
Dundee, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Reading, , United Kingdom
Salford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-014986-22
Identifier Type: -
Identifier Source: secondary_id
NC25113
Identifier Type: -
Identifier Source: org_study_id