Clinical trial NCT01018173: A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
Official title: A Randomized Double Blind, Placebo-controlled Clinical Trial to Assess the Effects of Taspoglutide (RO5073031) on Cardiovascular Outcomes in Subjects With Inadequately Controlled Type 2 Diabetes and Established Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 2118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and safety and the effects of taspoglutide on cardiovascular events in patients with inadequately controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or weekly sc placebo, in addition to background anti-hyperglycemic medication and standard of care treatment for cardiovascular disease. Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>18 years of age
* 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:

* diagnosis or history of type 1 diabetes or secondary forms of diabetes
* 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

Primary outcomes:
measure: Time to cardiovascular composite primary endpoints
timeFrame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
Secondary outcomes:
measure: Secondary cardiovascular composite endpoints
timeFrame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
measure: Individual components of primary cardiovascular composite endpoints
timeFrame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
measure: Total mortality
timeFrame: assessed at end of study, week 104
measure: Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, albumin/creatinine ratio (ACR), albuminuria, glomerular filtration rate (GFR)
timeFrame: laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Buena Park
country: United States
state: California
city: Calabasas
country: United States
state: California
city: Fresno
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Trumbull
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ponte Verde
country: United States
state: Florida
city: Bloomingdale
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Oxon Hill
country: United States
state: Maryland
city: Jackson
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: North Platte
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Nashua
country: United States
state: New Hampshire
city: Toms River
country: United States
state: New Jersey
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Calabash
country: United States
state: North Carolina
city: Cary
country: United States
state: North Carolina
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Mooresville
country: United States
state: North Carolina
city: Raleigh
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state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Bismark
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state: North Dakota
city: Cleveland
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state: Ohio
city: Kettering
country: United States
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city: Bend
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Portland
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state: Oregon
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state: Pennsylvania
city: Levittown
country: United States
state: Pennsylvania
city: Philadelphia
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city: Hickory
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state: Tennessee
city: Johnson City
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state: Tennessee
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city: Fort Worth
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city: North Richland Hills
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city: San Antonio
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city: Temple
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state: Utah
city: Burke
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state: Virginia
city: Hampton
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city: Richmond
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city: Winchester
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state: Washington
city: Freemantle
country: Australia
state: Queensland
city: Herston
country: Australia
state: Queensland
city: Elizabeth Vale
country: Australia
state: South Australia
city: Melbourne
country: Australia
state: Victoria
city: Fortaleza
country: Brazil
state: CE
city: Fortaleza
country: Brazil
state: CE
city: Campina Grande do Sul
country: Brazil
state: PR
city: Rio de Janeiro
country: Brazil
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city: Rio de Janeiro
country: Brazil
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city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
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country: Brazil
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country: Brazil
state: SP
city: Byala
country: Bulgaria
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Barrie
country: Canada
state: Ontario
city: Toronto
country: Canada
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city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Havirov
country: Czech Republic
city: Jindrichuv Hradec
country: Czech Republic
city: Marianske Lazne
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Pardubice
country: Czech Republic
city: Praha
country: Czech Republic
city: Rakovnik
country: Czech Republic
city: Ricany u Prahy
country: Czech Republic
city: Semily
country: Czech Republic
city: Trutnov
country: Czech Republic
city: Uherske Hradiste
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Aalborg
country: Denmark
city: Ballerup
country: Denmark
city: Hvidovre
country: Denmark
city: Vejle
country: Denmark
city: Paide
country: Estonia
city: Saku
country: Estonia
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Tartu
country: Estonia
city: Viljandimaa
country: Estonia
city: Voru
country: Estonia
city: Bad Lauterberg
country: Germany
city: Bad Oeynhausen
country: Germany
city: Bochum
country: Germany
city: Dortmund
country: Germany
city: Dresden
country: Germany
city: Essen
country: Germany
city: Hamburg
country: Germany
city: Kleve
country: Germany
city: Neuss
country: Germany
city: Nürnberg
country: Germany
city: Wuppertal
country: Germany
city: Balatonfuered
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyula
country: Hungary
city: Hodmezovasarhely
country: Hungary
city: Komarom
country: Hungary
city: Mako
country: Hungary
city: Sopron
country: Hungary
city: Szikszo
country: Hungary
city: Urhida
country: Hungary
city: Veszprem
country: Hungary
city: Ahmedabad
country: India
city: Aurangabad
country: India
city: Bangalore
country: India
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country: India
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country: India
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country: India
city: Banglore
country: India
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country: India
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country: India
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country: India
city: Cochin
country: India
city: Hyderabad
country: India
city: Jaipur
country: India
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country: India
city: Madurai
country: India
city: Mangalore
country: India
city: Mumbai
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city: Mumbai
country: India
city: Nagpur
country: India
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country: India
city: Pune
country: India
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country: India
city: Pune
country: India
city: Jerusalem
country: Israel
city: Alytus
country: Lithuania
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
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country: Lithuania
city: Klaipeda
country: Lithuania
city: Panevezys
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Johor
country: Malaysia
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country: Malaysia
city: Penang
country: Malaysia
city: Aguascalientes
country: Mexico
city: Chihuahua
country: Mexico
city: Cuernavaca
country: Mexico
city: Culiacan
country: Mexico
city: Durango
country: Mexico
city: Juarez, Distrito Federal
country: Mexico
city: Mexico City
country: Mexico
city: Mexico
country: Mexico
city: Monterrey
country: Mexico
city: Tampico
country: Mexico
city: Gdansk
country: Poland
city: Gdynia
country: Poland
city: Kamieniec Zabkowicki
country: Poland
city: Katowice
country: Poland
city: Kielce
country: Poland
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country: Poland
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country: Poland
city: Lodz
country: Poland
city: Plock
country: Poland
city: Poznan
country: Poland
city: Radom
country: Poland
city: Warszawa
country: Poland
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country: Poland
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country: Poland
city: Wroclaw
country: Poland
city: Bacau
country: Romania
city: Baia Mare
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucuresti
country: Romania
city: Constanta
country: Romania
city: Galati
country: Romania
city: Oradea
country: Romania
city: Ploiesti
country: Romania
city: Ploiesti
country: Romania
city: Targu Mures
country: Romania
city: Timisoara
country: Romania
city: Barnaul
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: S. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Dolny Kubin
country: Slovakia
city: Komarno
country: Slovakia
city: Levice
country: Slovakia
city: Levice
country: Slovakia
city: Lucenec
country: Slovakia
city: Prievidza
country: Slovakia
city: Trencin
country: Slovakia
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Johannesburg
country: South Africa
city: Johannesburg
country: South Africa
city: Observatory, Cape Town
country: South Africa
city: Port Elizabeth
country: South Africa
city: Pretoria
country: South Africa
city: Pretoria
country: South Africa
city: Richards Bay
country: South Africa
city: Soweto
country: South Africa
city: Soweto
country: South Africa
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan County
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Mykolaiv
country: Ukraine
city: Poltava
country: Ukraine
city: Ternopil
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Bexhill on Sea
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Chorley
country: United Kingdom
city: Dundee
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Reading
country: United Kingdom
city: Salford
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: