AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3EXAMINENCT00968708

Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome

A Phase 3 study testing Alogliptin in people with Diabetes Mellitus, Type 2 and Acute Coronary Syndrome, run by Takeda at 908 sites in 50 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Alogliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,380 participants
Where
908 sitesin 50 countries
Study dates
Sep 2009to Jun 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of type 2 diabetes mellitus
  • Is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the participant's antidiabetic regimen includes insulin)
  • Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization.

Who cannot join

  • Signs of type 1 diabetes mellitus
  • Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
  • Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening.

Trial locations and contacts

908 sites in 50 countries.

908 sites in 50 countries

United States292 sites

  • Study site

    Akron, Ohio

  • Study site

    Alameda, California

  • Study site

    Albuquerque, New Mexico

  • Study site

    Alexandria, Louisiana

  • Study site

    Aliso Viejo, California

  • Study site

    Alpena, Michigan

  • Study site

    Altoona, Pennsylvania

  • Study site

    Anaheim, California

  • Study site

    Annapolis, Maryland

  • Study site

    Asheville, North Carolina

  • Study site

    Athens, Ohio

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Aurora, Illinois

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Bartlesville, Oklahoma

  • Study site

    Bartlett, Tennessee

  • Study site

    Beaufort, South Carolina

  • Study site

    Beaumont, Texas

  • Study site

    Bell Gardens, California

  • Study site

    Beloit, Wisconsin

  • Study site

    Bend, Oregon

  • Study site

    Bennington, Vermont

  • Study site

    Berea, Ohio

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Beverly Hills, California

  • Study site

    Biddeford, Maine

  • Study site

    Birmingham, Alabama

  • Study site

    Bismarck, North Dakota

  • Study site

    Boardman, Ohio

  • Study site

    Boca Raton, Florida

  • Study site

    Boilingbrook, Illinois

  • Study site

    Bolingbrook, Illinois

  • Study site

    Boston, Massachusetts

  • Study site

    Bountiful, Utah

  • Study site

    Brandon, Florida

  • Study site

    Brick, New Jersey

  • Study site

    Bridgeport, Connecticut

  • Study site

    Bridgewater, New Jersey

  • Study site

    Bridgman, Michigan

  • Study site

    Bristol, Tennessee

  • Study site

    Brockton, Massachusetts

  • Study site

    Burke, Virginia

  • Study site

    Burlington, North Carolina

  • Study site

    Burr Ridge, Illinois

  • Study site

    Camden, New Jersey

  • Study site

    Carlisle, Ohio

  • Study site

    Carrollton, Texas

  • Study site

    Cartersville, Georgia

  • Study site

    Centerville, Ohio

  • Study site

    Charlotte, North Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Chesterfield, Missouri

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Cleveland, Tennessee

  • Study site

    Clymer, Pennsylvania

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbus, Ohio

  • Study site

    Conyers, Georgia

  • Study site

    Corona, California

  • Study site

    Cortlandt Manor, New York

  • Study site

    Corvallis, Oregon

  • Study site

    Cottonwood, Arizona

  • Study site

    Council Bluffs, Iowa

  • Study site

    Dallas, Texas

  • Study site

    Davie, Florida

  • Study site

    Daytona Beach, Florida

  • Study site

    Dearborn, Michigan

  • Study site

    Delray Beach, Florida

  • Study site

    Denton, Texas

  • Study site

    Detroit, Michigan

  • Study site

    Doral, Florida

  • Study site

    Dothan, Alabama

  • Study site

    Downey, California

  • Study site

    Duluth, Minnesota

  • Study site

    Dunwoody, Georgia

  • Study site

    Easley, South Carolina

  • Study site

    East Providence, Rhode Island

  • Study site

    Edinburg, Texas

  • Study site

    Elizabeth City, North Carolina

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Elkhart, Indiana

  • Study site

    Escondido, California

  • Study site

    Evansville, Indiana

  • Study site

    Everett, Washington

  • Study site

    Fall River, Massachusetts

  • Study site

    Fargo, North Dakota

  • Study site

    Fleetwood, Pennsylvania

  • Study site

    Fleming Island, Florida

  • Study site

    Florence, South Carolina

  • Study site

    Forsyth, North Carolina

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Lee, New Jersey

  • Study site

    Fort Worth, Texas

  • Study site

    Franklin, Ohio

  • Study site

    Franklin, Tennessee

  • Study site

    Freeport, New York

  • Study site

    Fullerton, California

  • Study site

    Galax, Virginia

  • Study site

    Germantown, Tennessee

  • Study site

    Goodyear, Arizona

  • Study site

    Grapevine, Texas

  • Study site

    Great Falls, Montana

  • Study site

    Green Bay, Wisconsin

  • Study site

    Greensboro, North Carolina

  • Study site

    Haddon Heights, New Jersey

  • Study site

    Hickory, North Carolina

  • Study site

    Hillsboro, Oregon

  • Study site

    Hollywood, Florida

  • Study site

    Houma, Louisiana

  • Study site

    Houston, Texas

  • Study site

    Huntington, New York

  • Study site

    Huntington Beach, California

  • Study site

    Huntington Park, California

  • Study site

    Indianapolis, Indiana

  • Study site

    Inglewood, California

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Jefferson City, Missouri

  • Study site

    Jerseyville, Illinois

  • Study site

    Johnson City, New York

  • Study site

    Johnson City, Tennessee

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kansas City, Missouri

  • Study site

    Kingsport, Tennessee

  • Study site

    Kingston, New York

  • Study site

    Kissimmee, Florida

  • Study site

    Knoxville, Tennessee

  • Study site

    La Mirada, California

  • Study site

    Lafayette, Louisiana

  • Study site

    Lake Mary, Florida

  • Study site

    Lakeridge, Virginia

  • Study site

    Lakewood, California

  • Study site

    Lancaster, California

  • Study site

    Langhorne, Pennsylvania

  • Study site

    Lapeer, Michigan

  • Study site

    Largo, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Lenoir, North Carolina

  • Study site

    Lexington, Kentucky

  • Study site

    Linden, New Jersey

  • Study site

    Little Rock, Arkansas

  • Study site

    Livonia, Michigan

  • Study site

    Lomita, California

  • Study site

    Long Beach, California

  • Study site

    Lorain, Ohio

  • Study site

    Los Angeles, California

  • Study site

    Los Gatos, California

  • Study site

    Madison, Wisconsin

  • Study site

    Madisonville, Kentucky

  • Study site

    Malvern, Arkansas

  • Study site

    Manassas, Virginia

  • Study site

    Manitowoc, Wisconsin

  • Study site

    Marietta, Georgia

  • Study site

    Marion, Ohio

  • Study site

    Maumee, Ohio

  • Study site

    McKinney, Texas

  • Study site

    Melbourne, Florida

  • Study site

    Melrose Park, Illinois

  • Study site

    Memphis, Tennessee

  • Study site

    Merced, California

  • Study site

    Mesa, Arizona

  • Study site

    Miami, Florida

  • Study site

    Miami Lakes, Florida

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Midland, Michigan

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Minot, North Dakota

  • Study site

    Mobile, Alabama

  • Study site

    Moline, Illinois

  • Study site

    Muncie, Indiana

  • Study site

    Munster, Indiana

  • Study site

    Murfreesboro, Tennessee

  • Study site

    Muscle Shoals, Alabama

  • Study site

    Muskegon, Michigan

  • Study site

    Nampa, Idaho

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    Natchitoches, Louisiana

  • Study site

    New Albany, Indiana

  • Study site

    New Brunswick, New Jersey

  • Study site

    New Hartford, New York

  • Study site

    New Orleans, Louisiana

  • Study site

    New Smyrna Beach, Florida

  • Study site

    New York, New York

  • Study site

    Newark, New Jersey

  • Study site

    Newport Beach, California

  • Study site

    Norfolk, Virginia

  • Study site

    North Richland Hills, Texas

  • Study site

    Northridge, California

  • Study site

    Oak Ridge, Tennessee

  • Study site

    Oakland, California

  • Study site

    Ocala, Florida

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Owensboro, Kentucky

  • Study site

    Oxon Hill, Maryland

  • Study site

    Pahrump, Nevada

  • Study site

    Palm Harbor, Florida

  • Study site

    Palm Springs, California

  • Study site

    Panama City, Florida

  • Study site

    Pembroke Pines, Florida

  • Study site

    Pensacola, Florida

  • Study site

    Peoria, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Pomona, California

  • Study site

    Portland, Oregon

  • Study site

    Quincy, Illinois

  • Study site

    Richmond, Virginia

  • Study site

    Ridgewood, New Jersey

  • Study site

    Roanoke, Virginia

  • Study site

    Rochester, Minnesota

  • Study site

    Rochester, New York

  • Study site

    Rockport, Maine

  • Study site

    Rockville, Maryland

  • Study site

    Saginaw, Michigan

  • Study site

    Saginaw, Texas

  • Study site

    Saint Cloud, Florida

  • Study site

    Saint Joseph, Missouri

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Dimas, California

  • Study site

    Santa Ana, California

  • Study site

    Santa Clarita, California

  • Study site

    Sarasota, Florida

  • Study site

    Saratoga Springs, New York

  • Study site

    Savannah, Georgia

  • Study site

    Schwenksville, Pennsylvania

  • Study site

    Scotland, Pennsylvania

  • Study site

    Searcy, Arkansas

  • Study site

    Sellersville, Pennsylvania

  • Study site

    Sewell, New Jersey

  • Study site

    Shawnee Mission, Kansas

  • Study site

    Sicklerville, New Jersey

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Slidell, Louisiana

  • Study site

    Smithfield, North Carolina

  • Study site

    South Burlington, Vermont

  • Study site

    South Plainfield, New Jersey

  • Study site

    Southlake, Texas

  • Study site

    Spartanburg, South Carolina

  • Study site

    Springfield, Illinois

  • Study site

    Springfield, Ohio

  • Study site

    Springfield Gardens, New York

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Stockton, California

  • Study site

    Stuart, Florida

  • Study site

    Suffolk, Virginia

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Tarzana, California

  • Study site

    Taylors, South Carolina

  • Study site

    Temple, Texas

  • Study site

    The Bronx, New York

  • Study site

    Toledo, Ohio

  • Study site

    Tomball, Texas

  • Study site

    Torrence, California

  • Study site

    Troy, Michigan

  • Study site

    Tucker, Georgia

  • Study site

    Tucson, Arizona

  • Study site

    Valhalla, New York

  • Study site

    Valparaiso, Indiana

  • Study site

    Van Nuys, California

  • Study site

    Ventura, California

  • Study site

    Vero Beach, Florida

  • Study site

    Virginia Beach, Virginia

  • Study site

    Warren, Michigan

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Waterford, Michigan

  • Study site

    Waukesha, Wisconsin

  • Study site

    Waycross, Georgia

  • Study site

    Westlake, Ohio

  • Study site

    White Hall, Arkansas

  • Study site

    Williamsville, New York

  • Study site

    Wilmington, North Carolina

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Yardley, Pennsylvania

  • Study site

    Ypsilanti, Michigan

  • Study site

    Yukon, Oklahoma

  • Study site

    Zanesville, Ohio

Other trials in United States

Brazil50 sites

  • Study site

    Aracaju, Sergipe

  • Study site

    Belem - PA

  • Study site

    Belo Horizonte - MG

  • Study site

    Belo Horizonte, Minas Gerais

  • Study site

    Blumenau

  • Study site

    Brasilia - DF

  • Study site

    Brasilia, Distrito Federal

  • Study site

    Campina Grande do Sul

  • Study site

    Campinas, Sao Paulo

  • Study site

    Campo Grande, Mato Grosso Do Sul

  • Study site

    Curitiba, Paraná

  • Study site

    Curitiba, Parana

  • Study site

    Fortaleza - CE

  • Study site

    Fortaleza, Ceara

  • Study site

    Goiânia

  • Study site

    Goiania, Goias

  • Study site

    Joinville

  • Study site

    Londrina/PR

  • Study site

    Macei0

  • Study site

    Marília

  • Study site

    Marilia, Sao Paulo

  • Study site

    Mogi das Cruzes

  • Study site

    Natal

  • Study site

    Natal, RN

  • Study site

    Passo Fundo, Rio Grande Do Sul

  • Study site

    Porto Alegre

  • Study site

    Porto Alegre - RS

  • Study site

    Porto Alegre, Rio Grande Do Sul

  • Study site

    Recife

  • Study site

    Recife, PE

  • Study site

    Recife, Pernambuco

  • Study site

    Rio de Janeiro, Rio de Janeiro

  • Study site

    Rio de Janeiro

  • Study site

    Rio de Janeiro - RJ

  • Study site

    Salvador - BA

  • Study site

    Salvador, Bahia

  • Study site

    Santo André

  • Study site

    São José do Rio Preto

  • Study site

    Sao Jose Do Rio Preto- SP

  • Study site

    Sao Jose Do Rio Preto, Sao Paulo

  • Study site

    Sao Jose, Santa Catarina

  • Study site

    São Paulo, São Paulo

  • Study site

    São Paulo

  • Study site

    Sao Paulo, Sao Paulo

  • Study site

    Sao Paulo, SP

  • Study site

    Sobral, CE

  • Study site

    Taguatinga

  • Study site

    Tatuí, São Paulo

  • Study site

    Uberlandia, Minas Gerais

  • Study site

    Votuporanga

Other trials in Brazil

Japan45 sites

  • Study site

    Ageo, Saitama

  • Study site

    Aichi-gun, Aichi-ken

  • Study site

    Amagasaki, Hyōgo

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Fukushima, Fukushima

  • Study site

    Funabashi, Chiba

  • Study site

    Gifu, Gifu

  • Study site

    Hamada, Shimane

  • Study site

    Higashihiroshima, Hiroshima

  • Study site

    Hino, Tokyo

  • Study site

    Imabari, Ehime

  • Study site

    Iwakuni-shi, Yamaguchi

  • Study site

    Kanazawa, Ishikawa-ken

  • Study site

    Kashiwa, Chiba

  • Study site

    Kasuga, Fukuoka

  • Study site

    Kawasaki, Kanagawa

  • Study site

    Kishiwada, Osaka

  • Study site

    Kitakyushu, Fukuoka

  • Study site

    Komatsushimachō, Tokushima

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Matsubara, Osaka

  • Study site

    Matsusaka, Mie-ken

  • Study site

    Nagasaki, Nagasaki

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nankoku, Kochi

  • Study site

    Niigata, Niigata

  • Study site

    Ohkawa-city, Fukuoka

  • Study site

    Ōita, Oita Prefecture

  • Study site

    Okayama, Okayama-ken

  • Study site

    Saga, Saga-ken

  • Study site

    Sagamihara-shi, Kanagawa

  • Study site

    Sakaidechō, Kagawa-ken

  • Study site

    Seto, Aichi-ken

  • Study site

    Shibukawa, Gunma

  • Study site

    Shimajiri-gun, Okinawa

  • Study site

    Suntou-gun, Shizuoka

  • Study site

    Tachikawa, Tokyo

  • Study site

    Takasaki, Gunma

  • Study site

    Tokushima, Tokushima

  • Study site

    Tokyo, Tokyo

  • Study site

    Tomakomai, Hokkaido

  • Study site

    Tomigusuku, Okinawa

  • Study site

    Uji-shi, Kyoto

  • Study site

    Wako, Saitama

  • Study site

    Yao-shi, Osaka

Other trials in Japan

Argentina37 sites

  • Study site

    Bahía Blanca

  • Study site

    Buenos Aires

  • Study site

    C0rdoba

  • Study site

    Capital Federal

  • Study site

    Capital Federal, Buenos Aires

  • Study site

    Carlos Paz, C0rdoba

  • Study site

    Ciudad Aut0noma de Buenos Aires

  • Study site

    Ciudad de C0rdoba

  • Study site

    Córdoba

  • Study site

    Cordoba - Cordoba

  • Study site

    Corrientes

  • Study site

    Derqui Pilar, Buenos Aires

  • Study site

    Formosa

  • Study site

    Haedo, Buenos Aires

  • Study site

    La Plata

  • Study site

    La Plata, Buenos Aires

  • Study site

    Mar del Plata

  • Study site

    Mar Del Plata, Provincia de Buenos Aires

  • Study site

    Mendoza

  • Study site

    Moron, Buenos Aires

  • Study site

    Olivos

  • Study site

    Quilmes

  • Study site

    Ramos Mejía

  • Study site

    Ramos Mejia, Buenos Aries

  • Study site

    Rosario

  • Study site

    Rosario - Santa Fe

  • Study site

    Rosario, Provincia de Santa Fe

  • Study site

    Salta

  • Study site

    San Isidro

  • Study site

    San Juan, San Juan

  • Study site

    San Justo

  • Study site

    San Luis

  • Study site

    San Miguel de Tucumán

  • Study site

    San Salvador de Jujuy

  • Study site

    Santa Fe

  • Study site

    Trelew, Chubut

  • Study site

    Villa María

Other trials in Argentina

Mexico33 sites

  • Study site

    Acapulco, Guerrero

  • Study site

    Aguascalientes

  • Study site

    Chihuahua City

  • Study site

    Chihuhua, Chihuhua

  • Study site

    Ciudad Obregon, Sonora

  • Study site

    Cuernavaca

  • Study site

    Cuernavaca, Morelos

  • Study site

    Culiacán

  • Study site

    Durango

  • Study site

    Guadalajara

  • Study site

    Guadalajara, Jalisco

  • Study site

    Merida, Yucatan

  • Study site

    Metepec

  • Study site

    Mexicali, Baja California

  • Study site

    México

  • Study site

    Mexico City

  • Study site

    Mexico City, Mexico

  • Study site

    Monclova, Coahuila

  • Study site

    Monterrey

  • Study site

    Monterrey, NL

  • Study site

    Monterrey, Nuevo Le0n

  • Study site

    Monterrey, Nuevo Leon

  • Study site

    Morelia, Michoacan

  • Study site

    Pachuca

  • Study site

    Saltillo

  • Study site

    Saltillo, Coahuila

  • Study site

    San Luis Potosí City

  • Study site

    San Luis Potosi.SLP

  • Study site

    Tijuana, Baja California Norte

  • Study site

    Tlalnepantla

  • Study site

    Tlalnepantla, Edo de Mexico

  • Study site

    Xalapa, Veracruz

  • Study site

    Zapopan

Other trials in Mexico

India32 sites

  • Study site

    Ahmedabad, Gujarat

  • Study site

    Anand, Gujarat

  • Study site

    Bangalore, Karnataka

  • Study site

    Belagavi, Karnataka

  • Study site

    Chennai, Tamil Nadu

  • Study site

    Chhatrapati Sambhajinagar, Maharashtra

  • Study site

    Coimbatore, Tamil Nadu

  • Study site

    Delhi, National Capital Territory of Delhi

  • Study site

    Hyderabad, Andhra Pradesh

  • Study site

    Jaipur, Rajasthan

  • Study site

    Jalandhar, Punjab

  • Study site

    Kochi, Kerala

  • Study site

    Kolkata, West Bengal

  • Study site

    Ludhiana, Punjab

  • Study site

    Madurai, Tamil Nadu

  • Study site

    Mangalore, Karnataka

  • Study site

    Manipal, Karnataka

  • Study site

    Mumbai, Maharashtra

  • Study site

    Mysore, Karnataka

  • Study site

    Nagpur, Maharashtra

  • Study site

    Nashik, Maharashtra

  • Study site

    Nellore, Andhra Pradesh

  • Study site

    New Delhi, National Capital Territory of Delhi

  • Study site

    Perumbākkam, Chennai

  • Study site

    Pune, Maharashtra

  • Study site

    Surat, Gujarat

  • Study site

    Thiruvananthapuram, Kerala

  • Study site

    Thrissur, Kerala

  • Study site

    Trivandrum, Kerala

  • Study site

    Vadodara, Gujarat

  • Study site

    Vijayawada, Andhra Pradesh

  • Study site

    Visakhapatnam, Andhra Pradesh

Other trials in India

Canada30 sites

  • Study site

    Abbotsford British Columbia, British Columbia

  • Study site

    Ajax, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Cambridge, Ontario

  • Study site

    Edmonton, Alberta

  • Study site

    Grand Falls-Windsor, Newfoundland and Labrador

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Greenfield, Quebec

  • Study site

    Greenfield Park, Quebec

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • Study site

    Kelowna, British Columbia

  • Study site

    Lachine, Quebec

  • Study site

    Mount Royal, Quebec

  • Study site

    Newmarket, Ontario

  • Study site

    Niagara Falls, Ontario

  • Study site

    Ontario, Ontario

  • Study site

    Oshawa, Ontario

  • Study site

    Pickering, Ontario

  • Study site

    Pointe-Claire, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Saint-Jérôme, Quebec

  • Study site

    Sainte-Foy, Quebec

  • Study site

    Sherbrooke, Quebec

  • Study site

    Smiths Falls, Ontario

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Terrebonne, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Victoria, British Columbia

Other trials in Canada

Poland28 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Częstochowa

  • Study site

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United Kingdom24 sites

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Germany20 sites

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Russia17 sites

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    Krasnodar

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Peru16 sites

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Hungary15 sites

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Slovakia15 sites

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Israel14 sites

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France13 sites

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Romania13 sites

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South Korea12 sites

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Australia11 sites

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Bulgaria11 sites

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Puerto Rico11 sites

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South Africa11 sites

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Spain11 sites

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Thailand11 sites

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Chile10 sites

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Philippines10 sites

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Croatia9 sites

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Italy9 sites

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Sweden8 sites

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Finland6 sites

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About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome

The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

Read the detailed description

Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor developed by Takeda for use in patients with type 2 diabetes mellitus.

Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus patients who have cardiovascular disease and are at high risk for major adverse cardiac events, such as those patients who have had recent acute coronary syndrome.

This study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to Standard of Care in adults with type 2 diabetes mellitus and acute coronary syndrome.

Being tested
Alogliptin, Placebo
Keywords
Diabetes Mellitus - Type 2, Diabetes Mellitus, cardiovascular outcomes, heart attack, stroke, dipeptidyl-peptidase IV inhibitors, metabolic disorders, metabolic diseases, glucose metabolism disorders
Medical subject headings
Diabetes Mellitus, Type 2, Acute Coronary Syndrome, Diabetes Mellitus, Myocardial Infarction, Stroke, Metabolic Diseases, Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlogliptinDrug

    Also called Nesina®, SYR-322, SYR110322

    Alogliptin tablets

  • PlaceboDrug

    Alogliptin placebo matching tablets

Study groups in NCT00968708
Study groupRoleWhat they receive
PlaceboExperimentalAlogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
Receives: Drug: Placebo
AlogliptinExperimentalAlogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
Receives: Drug: Alogliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)

    Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.

    Measured: From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).

Secondary outcomes (1)

  1. Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)

    Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee.

    Measured: From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionApr 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5,380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00968708
Sponsor's protocol ID
SYR-322_402
Other IDs
U1111-1111-6825, 2009-011222-34, JapicCTI-101246, DOH-27-0310-3047, 09/H0709/63, CTRI/2010/091/000046, 2009-011222-34, 2009-011222-34
Acronym
EXAMINE
Status last verified
Apr 2014
First submitted
28 Aug 2009
Last updated
2 May 2014
Data monitoring committee
Yes

Publications

  • Ferreira JP, Rossignol P, Bakris G, Mehta C, White WB, Zannad F. Blood and Urine Biomarkers Predicting Worsening Kidney Function in Patients with Type 2 Diabetes Post-Acute Coronary Syndrome: An Analysis from the EXAMINE Trial. Am J Nephrol. 2021;52(12):969-976. doi: 10.1159/000519436. Epub 2021 Dec 6.

    PubMed 34872085

  • Ferreira JP, Mehta C, Sharma A, Nissen SE, Rossignol P, Zannad F. Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial. BMC Med. 2020 Jun 4;18(1):165. doi: 10.1186/s12916-020-01616-8.

    PubMed 32493335

  • Sharma A, Vaduganathan M, Ferreira JP, Liu Y, Bakris GL, Cannon CP, White WB, Zannad F. Clinical and Biomarker Predictors of Expanded Heart Failure Outcomes in Patients With Type 2 Diabetes Mellitus After a Recent Acute Coronary Syndrome: Insights From the EXAMINE Trial. J Am Heart Assoc. 2020 Jan 7;9(1):e012797. doi: 10.1161/JAHA.119.012797. Epub 2020 Jan 4.

    PubMed 31902327

  • White WB, Jalil F, Cushman WC, Bakris GL, Bergenstal R, Heller SR, Liu Y, Mehta C, Zannad F, Cannon CP. Average Clinician-Measured Blood Pressures and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Ischemic Heart Disease in the EXAMINE Trial. J Am Heart Assoc. 2018 Oct 16;7(20):e009114. doi: 10.1161/JAHA.118.009114.

    PubMed 30371278

  • Jarolim P, White WB, Cannon CP, Gao Q, Morrow DA. Serial Measurement of Natriuretic Peptides and Cardiovascular Outcomes in Patients With Type 2 Diabetes in the EXAMINE Trial. Diabetes Care. 2018 Jul;41(7):1510-1515. doi: 10.2337/dc18-0109. Epub 2018 May 30.

    PubMed 29848776

  • Sharma A, Cannon CP, White WB, Liu Y, Bakris GL, Cushman WC, Zannad F. Early and Chronic Dipeptidyl-Peptidase-IV Inhibition and Cardiovascular Events in Patients With Type 2 Diabetes Mellitus After an Acute Coronary Syndrome: A Landmark Analysis of the EXAMINE Trial. J Am Heart Assoc. 2018 May 16;7(11):e007649. doi: 10.1161/JAHA.117.007649.

    PubMed 29769203

  • White WB, Heller SR, Cannon CP, Howitt H, Khunti K, Bergenstal RM; EXAMINE Investigators. Alogliptin in Patients with Type 2 Diabetes Receiving Metformin and Sulfonylurea Therapies in the EXAMINE Trial. Am J Med. 2018 Jul;131(7):813-819.e5. doi: 10.1016/j.amjmed.2018.02.023. Epub 2018 Mar 23.

    PubMed 29581078

  • Hwang YC, Morrow DA, Cannon CP, Liu Y, Bergenstal R, Heller S, Mehta C, Cushman W, Bakris GL, Zannad F, White WB. High-sensitivity C-reactive protein, low-density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial. Diabetes Obes Metab. 2018 Mar;20(3):654-659. doi: 10.1111/dom.13136. Epub 2017 Nov 21.

    PubMed 29064626

  • Kay S, Strickson A, Puelles J, Selby R, Benson E, Tolley K. Comparative Effectiveness of Adding Alogliptin to Metformin Plus Sulfonylurea with Other DPP-4 Inhibitors in Type 2 Diabetes: A Systematic Review and Network Meta-Analysis. Diabetes Ther. 2017 Apr;8(2):251-273. doi: 10.1007/s13300-017-0245-8. Epub 2017 Mar 8.

    PubMed 28275958

  • Cavender MA, White WB, Jarolim P, Bakris GL, Cushman WC, Kupfer S, Gao Q, Mehta CR, Zannad F, Cannon CP, Morrow DA. Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care). Circulation. 2017 May 16;135(20):1911-1921. doi: 10.1161/CIRCULATIONAHA.116.024632. Epub 2017 Feb 28.

    PubMed 28246236

  • White WB, Kupfer S, Zannad F, Mehta CR, Wilson CA, Lei L, Bakris GL, Nissen SE, Cushman WC, Heller SR, Bergenstal RM, Fleck PR, Cannon CP; EXAMINE Investigators. Cardiovascular Mortality in Patients With Type 2 Diabetes and Recent Acute Coronary Syndromes From the EXAMINE Trial. Diabetes Care. 2016 Jul;39(7):1267-73. doi: 10.2337/dc16-0303. Epub 2016 Jun 11.

    PubMed 27289121

  • Zannad F, Cannon CP, Cushman WC, Bakris GL, Menon V, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Lam H, White WB; EXAMINE Investigators. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet. 2015 May 23;385(9982):2067-76. doi: 10.1016/S0140-6736(14)62225-X. Epub 2015 Mar 10.

    PubMed 25765696

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alogliptin in people with Diabetes Mellitus, Type 2 and Acute Coronary Syndrome, run by Takeda at 908 sites in 50 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 908 sites in United States, Brazil, Japan, Argentina, Mexico and 45 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) (time frame: From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00968708, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2014.

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