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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Acute Coronary Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Alogliptin

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.

• Study Type: Interventional
• Enrollment (Actual): 5380
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Bahia Blanca, Argentina
  • Buenos Aires, Argentina
  • C0rdoba, Argentina
  • Capital Federal, Argentina
  • Capital Federal, Buenos Aires, Argentina
  • Carlos Paz, C0rdoba, Argentina
  • Ciudad Aut0noma de Buenos Aires, Argentina
  • Ciudad Autonoma de Buenos Aires, Argentina
  • Ciudad de C0rdoba, Argentina
  • Cordoba, Argentina
  • Cordoba - Cordoba, Argentina
  • Corrientes, Argentina
  • Derqui Pilar, Buenos Aires, Argentina
  • Formosa, Argentina
  • Haedo, Buenos Aires, Argentina
  • La Plata, Argentina
  • La Plata, Buenos Aires, Argentina
  • Mar del Plata, Argentina
  • Mar del Plata, Provincia de Buenos Aires, Argentina
  • Mendoza, Argentina
  • Moron, Buenos Aires, Argentina
  • Olivos, Argentina
  • Quilmes, Argentina
  • Ramos Mejia, Argentina
  • Ramos Mejia, Buenos Aries, Argentina
  • Rosario, Argentina
  • Rosario - Santa Fe, Argentina
  • Rosario, Provincia de Santa Fe, Argentina
  • Salta, Argentina
  • San Isidro, Argentina
  • San Juan, San Juan, Argentina
  • San Justo, Argentina
  • San Luis, Argentina
  • San Miguel de Tucuman, Argentina
  • San Salvador, de Jujuy, Argentina
  • Santa Fe, Argentina
  • Trelew, Chubut, Argentina
  • Villa Maria, Argentina
• Australia
  • Adelaide, SA, Australia
  • Bruce, Australia
  • New South Wales
    • Broken Hill, New South Wales, Australia
    • Kogarah, New South Wales, Australia
  • Queensland
    • Milton, Queensland, Australia
    • Nambour, Queensland, Australia
  • Tasmania
    • Hobart, Tasmania, Australia
  • Victoria
    • Fitzroy, Victoria, Australia
    • Frankston, Victoria, Australia
    • Heidelberg, Victoria, Australia
    • Prahran, Victoria, Australia
• Austria
  • Feldkirch, Austria
  • Graz, Austria
  • Salzburg, Austria
  • Wien, Austria
• Belgium
  • Antwerpen, Belgium
  • Bonheiden, Belgium
  • Brasschaat, Belgium
  • Brussel, Belgium
  • Bruxelles, Belgium
  • Gent, Belgium
  • La Louviere, Belgium
• Brazil
  • Aracaju, Sergipe, Brazil
  • Belem - PA, Brazil
  • Belo Horizonte - MG, Brazil
  • Belo Horizonte, Minas Gerais, Brazil
  • Blumenau, Brazil
  • Brasilia - DF, Brazil
  • Brasilia, Distrito Federal, Brazil
  • Campina Grande do Sul, Brazil
  • Campinas, Sao Paulo, Brazil
  • Campo Grande, Mato Grosso do Sul, Brazil
  • Curitiba, Parana, Brazil
  • Fortaleza - CE, Brazil
  • Fortaleza, Ceara, Brazil
  • Goiania, Brazil
  • Goiania, Goias, Brazil
  • Joinville, Brazil
  • Londrina/PR, Brazil
  • Macei0, Brazil
  • Marilia, Brazil
  • Marilia, Sao Paulo, Brazil
  • Mogi das Cruzes, Brazil
  • Natal, Brazil
  • Natal, RN, Brazil
  • Passo Fundo, Rio Grande do Sul, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre - RS, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Recife, Brazil
  • Recife, PE, Brazil
  • Recife, Pernambuco, Brazil
  • Rio de Janeiro, Brazil
  • Rio de Janeiro - RJ, Brazil
  • Salvador - BA, Brazil
  • Salvador, Bahia, Brazil
  • Santo Andre, Brazil
  • Sao Jose do Rio Preto, Brazil
  • Sao Jose do Rio Preto, Sao Paulo, Brazil
  • Sao Jose do Rio Preto- SP, Brazil
  • Sao Jose, Santa Catarina, Brazil
  • Sao Paulo, Brazil
  • Sao Paulo, SP, Brazil
  • Sao Paulo, Sao Paulo, Brazil
  • Sobral, CE, Brazil
  • Taguatinga, Brazil
  • Uberlandia, Minas Gerais, Brazil
  • Votuporanga, Brazil
  • PR
    • Curitiba, PR, Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil
  • SP
    • Sao Paulo, SP, Brazil
    • Tatui, SP, Brazil
• Bulgaria
  • Blagoevgrad, Bulgaria
  • Dimitrovgrad, Bulgaria
  • Kazanlak, Bulgaria
  • Lovech, Bulgaria
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Sevlievo, Bulgaria
  • Smolian, Bulgaria
  • Sofia, Bulgaria
  • Stara Zagora, Bulgaria
  • Varna, Bulgaria
• Canada
  • Ontario, Canada
  • Quebec, Canada
  • Alberta
    • Calgary, Alberta, Canada
    • Edmonton, Alberta, Canada
  • British Columbia
    • Abbotsford, British Columbia, Canada
    • Kelowna, British Columbia, Canada
    • Vancouver, British Columbia, Canada
    • Victoria, British Columbia, Canada
  • Newfoundland and Labrador
    • Grand Falls-Windsor, Newfoundland and Labrador, Canada
    • St. John's, Newfoundland and Labrador, Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
  • Ontario
    • Ajax, Ontario, Canada
    • Cambridge, Ontario, Canada
    • Hamilton, Ontario, Canada
    • Newmarket, Ontario, Canada
    • Niagara Falls, Ontario, Canada
    • Oshawa, Ontario, Canada
    • Pickering, Ontario, Canada
    • Smiths Falls, Ontario, Canada
    • Sudbury, Ontario, Canada
    • Toronto, Ontario, Canada
  • Quebec
    • Greenfield, Quebec, Canada
    • Greenfield Park, Quebec, Canada
    • Lachine, Quebec, Canada
    • Mont-Royal, Quebec, Canada
    • Pointe Claire, Quebec, Canada
    • Pointe-Claire, Quebec, Canada
    • Sainte-Foy, Quebec, Canada
    • Sherbrooke, Quebec, Canada
    • St. Jerome, Quebec, Canada
    • Terrebonne, Quebec, Canada
• Chile
  • Antofagasta, Chile
  • Antofagasta, Region II, Chile
  • Iquique, Region I, Chile
  • Osorno, Chile
  • Rancagua, Chile
  • Santiago, Chile
  • Talcahuano, Chile
  • Temuco, Chile
  • Temuco, Region de la Araucania, Chile
  • Vina del Mar, Chile
• Colombia
  • Barranquilla, Colombia
  • Bogota, Colombia
  • Bucaramanga, Colombia
  • Medellin, Colombia
• Croatia
  • Cakovec, Croatia
  • Krapinske Toplice, Croatia
  • Osijek, Croatia
  • Rijeka, Croatia
  • Sisak, Croatia
  • Split, Croatia
  • Virovitica, Croatia
  • Zadar, Croatia
  • Zagreb, Croatia
• Czech Republic
  • Caslav, Czech Republic
  • Hradec Kralove, Czech Republic
  • Olomouc, Czech Republic
  • Ostrava - Vitkovice, Czech Republic
  • Zlin, Czech Republic
  • Znojmo, Czech Republic
• Denmark
  • Herlev, Denmark
  • Herning, Denmark
  • Kobenhavn NV, Denmark
• Egypt
  • Alexandria, Egypt
  • Giza, Egypt
  • Monofia, Egypt
• Finland
  • Helsinki, Finland
  • Jyvaskyla, Finland
  • Kokkola, Finland
  • Kuopio, Finland
  • Tampere, Finland
  • Turku, Finland
• France
  • Bordeaux, France
  • Corbeil Essonnes, France
  • Corbeil-Essonnes, France
  • Creteil, France
  • Dijon, France
  • La Rochelle, France
  • Lille, France
  • Montpellier, France
  • Narbonne, France
  • Paris, France
  • Pau, France
  • Pessac, France
  • Rennes, France
  • Toulouse, France
• Germany
  • Bad Nauheim, Germany
  • Bensheim, Germany
  • Berlin, Germany
  • Dortmund, Germany
  • Dresden, Germany
  • Essen, Germany
  • Halle (Saale), Germany
  • Jena, Germany
  • Kassel, Germany
  • Koln, Germany
  • Leipzig, Germany
  • Mainz, Germany
  • Mannheim, Germany
  • Muenchen, Germany
  • Munster, Germany
  • Neumuenster, Germany
  • Neuwied, Germany
  • Sankt Ingbert, Germany
  • Siegen, Germany
  • Wangen, Germany
• Greece
  • Marousi, Greece
• Guatemala
  • Guatemala, Guatemala
  • Guatemala City, Guatemala
  • Quetzaltenango, Guatemala
• Hong Kong
  • Hong Kong, Hong Kong
  • Kowloon, Hong Kong
  • Shatin, Hong Kong
  • Tsuen Wan, Hong Kong
• Hungary
  • Budaors, Hungary
  • Budapest, Hungary
  • Debrecen, Hungary
  • Dunaujvaros, Hungary
  • Gyula, Hungary
  • H0dmezovasarhely, Hungary
  • Kaposvar, Hungary
  • Kecskemet, Hungary
  • Nagykanizsa, Hungary
  • Pecs, Hungary
  • Sopron, Hungary
  • Szekesfehervar, Hungary
  • Szentes, Hungary
  • Szombathely, Hungary
  • Zalaegerszeg, Hungary
• India
  • Delhi, India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India
    • Nellore, Andhra Pradesh, India
    • Vijayawada, Andhra Pradesh, India
    • Visakhapatnam, Andhra Pradesh, India
  • Chennai
    • Perumbakkam, Chennai, India
  • Delhi
    • New Delhi, Delhi, India
  • Gujarat
    • Ahmedabad, Gujarat, India
    • Anand, Gujarat, India
    • Surat, Gujarat, India
    • Vadodara, Gujarat, India
  • Karnataka
    • Bangalore, Karnataka, India
    • Belgaum, Karnataka, India
    • Mangalore, Karnataka, India
    • Manipal, Karnataka, India
    • Mysore, Karnataka, India
  • Kerala
    • Cochin, Kerala, India
    • Kochi, Kerala, India
    • Thiruvananthapuram, Kerala, India
    • Thrissur, Kerala, India
    • Trivandrum, Kerala, India
  • Maharashtra
    • Aurangabad, Maharashtra, India
    • Mumbai, Maharashtra, India
    • Nagpur, Maharashtra, India
    • Nashik, Maharashtra, India
    • Pune, Maharashtra, India
  • Punjab
    • Jalandhar, Punjab, India
    • Ludhiana, Punjab, India
  • Rajasthan
    • Jaipur, Rajasthan, India
  • Tamil Nadu
    • Chennai, Tamil Nadu, India
    • Coimbatore, Tamil Nadu, India
    • Madurai, Tamil Nadu, India
  • West Bengal
    • Kolkatta, West Bengal, India
• Israel
  • Ashkelon, Israel
  • Beer Sheva, Israel
  • Haifa, Israel
  • Holon, Israel
  • Jerusalem, Israel
  • Kfar-Saba, Israel
  • Nahariya, Israel
  • Nazareth, Israel
  • Petach Tikva, Israel
  • Rehovot, Israel
  • Rishon Lezion, Israel
  • Safed, Israel
  • Tel Aviv, Israel
  • Tiberias, Israel
• Italy
  • Cosenza, Italy
  • Isernia, Italy
  • Milano, Italy
  • Napoli, Italy
  • Palermo, Italy
  • Pavia, Italy
  • Ravenna, Italy
  • Roma, Italy
  • Sesto San Giovanni, Italy
• Japan
  • Niigata, Japan
  • Saga, Japan
  • Tokyo, Japan
  • Aichi
    • Aichi-gun, Aichi, Japan
    • Nagoya,, Aichi, Japan
    • Seto city, Aichi, Japan
  • Chiba
    • Funabashi-city, Chiba, Japan
    • Kashiwa city, Chiba, Japan
  • Ehime
    • Imabari, Ehime, Japan
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan
    • Kasuga-city, Fukuoka, Japan
    • Kitakyusyu, Fukuoka, Japan
    • Ohkawa-city, Fukuoka, Japan
  • Fukushima
    • Fukushima-shi, Fukushima, Japan
  • Gifu
    • Gifu-city, Gifu, Japan
  • Gunma
    • Shibukawa, Gunma, Japan
    • Takasaki, Gunma, Japan
  • Hiroshima
    • Higashihiroshima-city, Hiroshima, Japan
  • Hokkaido
    • Tomakomai-city, Hokkaido, Japan
  • Hyogo
    • Amagasaki-city, Hyogo, Japan
  • Ishikawa
    • Kanazawa, Ishikawa, Japan
  • Kagawa
    • Sakaide City, Kagawa, Japan
  • Kanagawa
    • Kawasaki, Kanagawa, Japan
    • Sagamihara-shi, Kanagawa, Japan
  • Kochi
    • Nankoku-city, Kochi, Japan
  • Kumamoto
    • Kumamoto-city, Kumamoto, Japan
  • Kyoto
    • Uji-shi, Kyoto, Japan
  • Mie
    • Matsusaka City, Mie, Japan
  • Nagasaki
    • Nagasaki-city, Nagasaki, Japan
    • Nagasaki-shi, Nagasaki, Japan
  • Oita
    • Oita-city, Oita, Japan
  • Okayama
    • Okayama-city, Okayama, Japan
  • Okinawa
    • Shimajiri-gun, Okinawa, Japan
    • Tomigusuku City, Okinawa, Japan
  • Osaka
    • Kishiwada-city, Osaka, Japan
    • Matsubara-city, Osaka, Japan
    • Yao-shi, Osaka, Japan
  • Saitama
    • Ageo, Saitama, Japan
    • Wako-city, Saitama, Japan
  • Shimane
    • Hamada-city, Shimane, Japan
  • Shizuoka
    • Suntou-gun, Shizuoka, Japan
  • Tokushima
    • Komatsushima-city, Tokushima, Japan
    • Tokushima-city, Tokushima, Japan
  • Tokyo
    • Hino, Tokyo, Japan
    • Tachikawa-city, Tokyo, Japan
  • Yamaguchi
    • Iwakuni-shi, Yamaguchi, Japan
• Korea, Republic of
  • Anyang, Korea, Republic of
  • Busan, Korea, Republic of
  • Daegu, Korea, Republic of
  • Goyang-Si, Korea, Republic of
  • Guri, Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
  • Jeonju-si, Korea, Republic of
  • Kangwon-do, Korea, Republic of
  • Pusan, Korea, Republic of
  • Seoul, Korea, Republic of
  • Suwon, Korea, Republic of
  • Yangsan, Korea, Republic of
• Kuwait
  • Dasman, Kuwait
• Latvia
  • Daugavpils, Latvia
  • Ogre, Latvia
  • Riga, Latvia
  • Tukums, Latvia
  • Valmiera, Latvia
• Lithuania
  • Kaunas, Lithuania
  • Kedainiai, Lithuania
  • Klaipeda, Lithuania
  • Palanga, Lithuania
  • Panevezys, Lithuania
  • Vilnius, Lithuania
• Malaysia
  • Alor Setar, Malaysia
  • Batu Caves, Malaysia
  • Georgetown, Malaysia
  • Kuala Lumpur, Malaysia
  • Kuantan, Malaysia
  • Kubang Kerian, Malaysia
  • Pulau Pinang, Malaysia
  • Selangor, Malaysia
• Mexico
  • Acapulco, Guerrero, Mexico
  • Aguascalientes, Mexico
  • Chihuahua, Mexico
  • Chihuhua, Chihuhua, Mexico
  • Ciudad Obregon, Sonora, Mexico
  • Cuernavaca, Mexico
  • Cuernavaca, Morelos, Mexico
  • Culiacan, Mexico
  • Durango, Mexico
  • Guadalajara, Mexico
  • Guadalajara, Jalisco, Mexico
  • Merida, Yucatan, Mexico
  • Metepec, Mexico
  • Mexicali, Baja California, Mexico
  • Mexico, Mexico
  • Mexico City, Mexico
  • Mexico City, Mexico, Mexico
  • Monclova, Coahuila, Mexico
  • Monterrey, Mexico
  • Monterrey, NL, Mexico
  • Monterrey, Nuevo Le0n, Mexico
  • Monterrey, Nuevo Leon, Mexico
  • Morelia, Michoacan, Mexico
  • Pachuca, Mexico
  • Saltillo, Mexico
  • Saltillo, Coahuila, Mexico
  • San Luis Potosi, Mexico
  • San Luis Potosi.SLP, Mexico
  • Tijuana, Baja California Norte, Mexico
  • Tlalnepantla, Mexico
  • Tlalnepantla, Edo de Mexico, Mexico
  • Xalapa, Veracruz, Mexico
  • Zapopan, Mexico
• New Zealand
  • Auckland, New Zealand
  • Christchurch, New Zealand
  • Otahuhu, New Zealand
  • Palmerston North, New Zealand
  • Takapuna, New Zealand
  • Tauranga, New Zealand
• Peru
  • Arequipa, Peru
  • Bellavista, Peru
  • Callao, Peru
  • Cusco, Peru
  • Huacho, Peru
  • Ica, Peru
  • La Victoria, Lima, Peru
  • Lima, Peru
  • Lima San Isidro, Peru
  • Los Olivos, Peru
  • Miraflores, Lima, Peru
  • Piura, Peru
  • San Isidro, Lima, Peru
  • San Miguel, Lima, Peru
  • Trujillo, Peru
  • Trujillo, La Libertad, Peru
• Philippines
  • Baguio, Philippines
  • Dasmarinas, Philippines
  • Davao City, Philippines
  • Iloilo City, Philippines
  • Laoag City, Philippines
  • Makati City, Philippines
  • Manila, Philippines
  • Marikina City, Philippines
  • Pasig City, Philippines
  • Quezon City, Philippines
• Poland
  • Bialystok, Poland
  • Bydgoszcz, Poland
  • Czestochowa, Poland
  • Dabrowa Gornicza, Poland
  • Elblag, Poland
  • Gdansk, Poland
  • Gdynia, Poland
  • Grodzisk Mazowiecki, Poland
  • Inowroclaw, Poland
  • Katowice, Poland
  • Kielce, Poland
  • Krakow, Poland
  • Legnica, Poland
  • Lodz, Poland
  • Lubartow, Poland
  • Lublin, Poland
  • Plock, Poland
  • Pulawy, Poland
  • Radom, Poland
  • Ruda Slaska, Poland
  • Skierniewice, Poland
  • Slupsk, Poland
  • Szczecin, Poland
  • Torun, Poland
  • Warsaw, Poland
  • Warszawa, Poland
  • Wroclaw, Poland
  • Zabrze, Poland
  • Zgierz, Poland
• Portugal
  • Coimbra, Portugal
  • Faro, Portugal
  • Lisboa, Portugal
  • Vila Real, Portugal
• Puerto Rico
  • Aibonito, Puerto Rico
  • Carolina, Puerto Rico
  • Cidra, Puerto Rico
  • Halo Rey, Puerto Rico
  • Levittown, Puerto Rico
  • Manati, Puerto Rico
  • Mayaguez, Puerto Rico
  • Ponce, Puerto Rico
  • Salinas, Puerto Rico
  • San Juan, Puerto Rico
  • Santurce, Puerto Rico
• Romania
  • Bacau, Romania
  • Baia Mare, Romania
  • Braila, Romania
  • Brasov, Romania
  • Bucharest, Romania
  • Bucuresti, Romania
  • Buzau, Romania
  • Galati, Romania
  • Iasi, Romania
  • Oradea, Romania
  • Ploiesti, Romania
  • Satu Mare, Romania
  • Targu Mures, Romania
  • Timisoara, Romania
• Russian Federation
  • Arkhangelsk, Russian Federation
  • Barnaul, Russian Federation
  • Ivanovo, Russian Federation
  • Kazan, Russian Federation
  • Kemerovo, Russian Federation
  • Krasnodar, Russian Federation
  • Krasnoyarsk, Russian Federation
  • Kursk, Russian Federation
  • Moscow, Russian Federation
  • Nizhniy Novgorod, Russian Federation
  • Novosibirsk, Russian Federation
  • Rostov-on-Don, Russian Federation
  • Saratov, Russian Federation
  • St. Petersburg, Russian Federation
  • Ufa, Russian Federation
  • Volgograd, Russian Federation
  • Vsevolozhsk, Russian Federation
• Serbia
  • Belgrade, Serbia
  • Beograd, Serbia
  • Nis, Serbia
• Slovakia
  • Bardejov, Slovakia
  • Bratislava, Slovakia
  • Dolny Kubin, Slovakia
  • Komarno, Slovakia
  • Kosice, Slovakia
  • Kosice - Saca, Slovakia
  • Levice, Slovakia
  • Liptovsky Hradok, Slovakia
  • Nove Mesto nad Vahom, Slovakia
  • Nove Zamky, Slovakia
  • Povazska Bystrica, Slovakia
  • Rimavska Sobota, Slovakia
  • Ruzomberok, Slovakia
  • Svidnik, Slovakia
  • Zilina, Slovakia
• South Africa
  • Durban, South Africa
  • Pretoria, South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa
    • Pretoria, Gauteng, South Africa
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa
    • Paarl, Western Cape, South Africa
    • Somerset West, Western Cape, South Africa
    • Tygerberg, Western Cape, South Africa
    • Worcester, Western Cape, South Africa
• Spain
  • Bacarot, Spain
  • Merida, Spain
  • Palma de Mallorca, Spain
  • Arag0n
    • Zaragoza, Arag0n, Spain
  • Asturias
    • Oviedo, Asturias, Spain
  • Castilla-La Mancha
    • Cuenca, Castilla-La Mancha, Spain
  • Cataluna
    • Barcelona, Cataluna, Spain
    • Figueres, Cataluna, Spain
  • Comunidad Valenciana
    • Torrevieja, Comunidad Valenciana, Spain
  • Galicia
    • A Coruna, Galicia, Spain
    • Santiago de Compostela, Galicia, Spain
• Sweden
  • Dalby, Sweden
  • Falkoping, Sweden
  • Goteborg, Sweden
  • Harnosand, Sweden
  • Kristianstad, Sweden
  • Malmo, Sweden
  • Motala, Sweden
  • Stockholm, Sweden
• Taiwan
  • Kaohsiung, Taiwan
  • Taipei County, Taiwan
  • Taoyuan, Taiwan
• Thailand
  • Amphure Muang, Thailand
  • Bangkojk, Thailand
  • Bangkok, Thailand
  • Chiang Rai, Thailand
  • Chiangmai, Thailand
  • Muang, Thailand
  • Nakhon Ratchasima, Thailand
  • Pathumwan, Thailand
  • Patumthani, Thailand
  • Phitsanulok, Thailand
  • Phrae, Thailand
• Turkey
  • Ankara, Balgat, Turkey
  • Antalya, Turkey
  • Istanbul, Turkey
  • Kayseri, Turkey
  • Konya, Turkey
• Ukraine
  • Donetsk, Ukraine
  • Ivano-Frankivsk, Ukraine
  • Kharkiv, Ukraine
  • Kyiv, Ukraine
  • Lviv, Ukraine
  • Odesa, Ukraine
  • Poltava, Ukraine
  • Simferopol, Ukraine
  • Vinnytsya, Ukraine
  • Zaporizhzhya, Ukraine
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
• United Kingdom
  • Barnsley, United Kingdom
  • Bath, United Kingdom
  • Birmingham, United Kingdom
  • Bournemouth, United Kingdom
  • Carshalton, United Kingdom
  • Chertsey, United Kingdom
  • Chichester, United Kingdom
  • Colchester, United Kingdom
  • Coventry, United Kingdom
  • Croydon, United Kingdom
  • Doncaster, United Kingdom
  • Glasgow, United Kingdom
  • Hull, United Kingdom
  • Inverness, United Kingdom
  • Kirkcaldy, United Kingdom
  • Liverpool, United Kingdom
  • Livingston, United Kingdom
  • London, United Kingdom
  • Nuneaton, United Kingdom
  • Stevenage, United Kingdom
  • Sunderland, United Kingdom
  • Torquay, United Kingdom
  • Wakefield, United Kingdom
  • West Midlands, United Kingdom
• United States
  • Alabama
    • Birmingham, Alabama, United States
    • Dothan, Alabama, United States
    • Mobile, Alabama, United States
    • Muscle Shoals, Alabama, United States
  • Arizona
    • Cottonwood, Arizona, United States
    • Goodyear, Arizona, United States
    • Mesa, Arizona, United States
    • Phoenix, Arizona, United States
    • Tucson, Arizona, United States
  • Arkansas
    • Little Rock, Arkansas, United States
    • Malvern, Arkansas, United States
    • Searcy, Arkansas, United States
    • White Hall, Arkansas, United States
  • California
    • Alameda, California, United States
    • Aliso Viejo, California, United States
    • Anaheim, California, United States
    • Bell Gardens, California, United States
    • Beverly Hills, California, United States
    • Chula Vista, California, United States
    • Corona, California, United States
    • Downey, California, United States
    • Escondido, California, United States
    • Fullerton, California, United States
    • Huntington Beach, California, United States
    • Huntington Park, California, United States
    • Inglewood, California, United States
    • La Mirada, California, United States
    • Lakewood, California, United States
    • Lancaster, California, United States
    • Lomita, California, United States
    • Long Beach, California, United States
    • Los Angeles, California, United States
    • Los Gatos, California, United States
    • Merced, California, United States
    • Newport Beach, California, United States
    • Northridge, California, United States
    • Oakland, California, United States
    • Palm Springs, California, United States
    • Pomona, California, United States
    • San Diego, California, United States
    • San Dimas, California, United States
    • Santa Ana, California, United States
    • Santa Clarita, California, United States
    • Stockton, California, United States
    • Tarzana, California, United States
    • Torrence, California, United States
    • Van Nuys, California, United States
    • Ventura, California, United States
  • Colorado
    • Aurora, Colorado, United States
    • Colorado Springs, Colorado, United States
  • Connecticut
    • Bridgeport, Connecticut, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Boca Raton, Florida, United States
    • Brandon, Florida, United States
    • Davie, Florida, United States
    • Daytona Beach, Florida, United States
    • DelRay Beach, Florida, United States
    • Doral, Florida, United States
    • Fleming Island, Florida, United States
    • Ft Lauderdale, Florida, United States
    • Hollywood, Florida, United States
    • Jacksonville, Florida, United States
    • Kissimmee, Florida, United States
    • Lake Mary, Florida, United States
    • Largo, Florida, United States
    • Melbourne, Florida, United States
    • Miami, Florida, United States
    • Miami Lakes, Florida, United States
    • Naples, Florida, United States
    • New Smyrna Beach, Florida, United States
    • Ocala, Florida, United States
    • Orlando, Florida, United States
    • Palm Harbor, Florida, United States
    • Panama City, Florida, United States
    • Pembroke Pines, Florida, United States
    • Pensacola, Florida, United States
    • Sarasota, Florida, United States
    • St. Cloud, Florida, United States
    • St. Petersburg, Florida, United States
    • Stuart, Florida, United States
    • Tampa, Florida, United States
    • Vero Beach, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
    • Cartersville, Georgia, United States
    • Conyers, Georgia, United States
    • Dunwoody, Georgia, United States
    • Marietta, Georgia, United States
    • Savannah, Georgia, United States
    • Tucker, Georgia, United States
    • Waycross, Georgia, United States
  • Idaho
    • Nampa, Idaho, United States
  • Illinois
    • Aurora, Illinois, United States
    • Boilingbrook, Illinois, United States
    • Bolingbrook, Illinois, United States
    • Burr Ridge, Illinois, United States
    • Chicago, Illinois, United States
    • Jerseyville, Illinois, United States
    • Melrose Park, Illinois, United States
    • Moline, Illinois, United States
    • Peoria, Illinois, United States
    • Quincy, Illinois, United States
    • Springfield, Illinois, United States
  • Indiana
    • Elkhart, Indiana, United States
    • Evansville, Indiana, United States
    • Indianapolis, Indiana, United States
    • Muncie, Indiana, United States
    • Munster, Indiana, United States
    • New Albany, Indiana, United States
    • Valparaiso, Indiana, United States
  • Iowa
    • Council Bluffs, Iowa, United States
  • Kansas
    • Shawnee Mission, Kansas, United States
  • Kentucky
    • Elizabethtown, Kentucky, United States
    • Lexington, Kentucky, United States
    • Madisonville, Kentucky, United States
    • Owensboro, Kentucky, United States
  • Louisiana
    • Alexandria, Louisiana, United States
    • Houma, Louisiana, United States
    • Lafayette, Louisiana, United States
    • Natchitoches, Louisiana, United States
    • New Orleans, Louisiana, United States
    • Slidell, Louisiana, United States
  • Maine
    • Biddeford, Maine, United States
    • Rockport, Maine, United States
  • Maryland
    • Annapolis, Maryland, United States
    • Baltimore, Maryland, United States
    • Oxon Hill, Maryland, United States
    • Rockville, Maryland, United States
  • Massachusetts
    • Boston, Massachusetts, United States
    • Brockton, Massachusetts, United States
    • Fall River, Massachusetts, United States
  • Michigan
    • Alpena, Michigan, United States
    • Bridgman, Michigan, United States
    • Dearborn, Michigan, United States
    • Detroit, Michigan, United States
    • Kalamazoo, Michigan, United States
    • Lapeer, Michigan, United States
    • Livonia, Michigan, United States
    • MIdland, Michigan, United States
    • Muskegon, Michigan, United States
    • Saginaw, Michigan, United States
    • Troy, Michigan, United States
    • Warren, Michigan, United States
    • Waterford, Michigan, United States
    • Ypsilanti, Michigan, United States
  • Minnesota
    • Duluth, Minnesota, United States
    • Minneapolis, Minnesota, United States
    • Rochester, Minnesota, United States
  • Missouri
    • Chesterfield, Missouri, United States
    • Jefferson City, Missouri, United States
    • Kansas City, Missouri, United States
    • St. Joseph, Missouri, United States
    • St. Louis, Missouri, United States
  • Montana
    • Great Falls, Montana, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • Nevada
    • Las Vegas, Nevada, United States
    • Pahrump, Nevada, United States
  • New Jersey
    • Brick, New Jersey, United States
    • Bridgewater, New Jersey, United States
    • Camden, New Jersey, United States
    • Fort Lee, New Jersey, United States
    • Haddon Heights, New Jersey, United States
    • Linden, New Jersey, United States
    • New Brunswick, New Jersey, United States
    • Newark, New Jersey, United States
    • Ridgewood, New Jersey, United States
    • Sewell, New Jersey, United States
    • Sicklerville, New Jersey, United States
    • South Plainfield, New Jersey, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • Bronx, New York, United States
    • Cortlandt Manor, New York, United States
    • Freeport, New York, United States
    • Huntington, New York, United States
    • Johnson City, New York, United States
    • Kingston, New York, United States
    • New Hartford, New York, United States
    • New York, New York, United States
    • Rochester, New York, United States
    • Saratoga Springs, New York, United States
    • Springfield Gardens, New York, United States
    • Valhalla, New York, United States
    • Williamsville, New York, United States
  • North Carolina
    • Asheville, North Carolina, United States
    • Burlington, North Carolina, United States
    • Charlotte, North Carolina, United States
    • Elizabeth City, North Carolina, United States
    • Forsyth, North Carolina, United States
    • Greensboro, North Carolina, United States
    • Hickory, North Carolina, United States
    • Lenoir, North Carolina, United States
    • Smithfield, North Carolina, United States
    • Wilmington, North Carolina, United States
    • Winston-Salem, North Carolina, United States
  • North Dakota
    • Bismarck, North Dakota, United States
    • Fargo, North Dakota, United States
    • Minot, North Dakota, United States
  • Ohio
    • Akron, Ohio, United States
    • Athens, Ohio, United States
    • Berea, Ohio, United States
    • Boardman, Ohio, United States
    • Carlisle, Ohio, United States
    • Centerville, Ohio, United States
    • Cincinnati, Ohio, United States
    • Cleveland, Ohio, United States
    • Columbus, Ohio, United States
    • Franklin, Ohio, United States
    • Lorain, Ohio, United States
    • Marion, Ohio, United States
    • Maumee, Ohio, United States
    • Middleburg Heights, Ohio, United States
    • Springfield, Ohio, United States
    • Toledo, Ohio, United States
    • Westlake, Ohio, United States
    • Zanesville, Ohio, United States
  • Oklahoma
    • Bartlesville, Oklahoma, United States
    • Oklahoma City, Oklahoma, United States
    • Yukon, Oklahoma, United States
  • Oregon
    • Bend, Oregon, United States
    • Corvallis, Oregon, United States
    • Hillsboro, Oregon, United States
    • Portland, Oregon, United States
  • Pennsylvania
    • Altoona, Pennsylvania, United States
    • Bethlehem, Pennsylvania, United States
    • Clymer, Pennsylvania, United States
    • Fleetwood, Pennsylvania, United States
    • Langhorne, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States
    • Pittsburgh, Pennsylvania, United States
    • Schwenksville, Pennsylvania, United States
    • Scotland, Pennsylvania, United States
    • Sellersville, Pennsylvania, United States
    • Yardley, Pennsylvania, United States
  • Rhode Island
    • East Providence, Rhode Island, United States
  • South Carolina
    • Beaufort, South Carolina, United States
    • Easley, South Carolina, United States
    • Florence, South Carolina, United States
    • Spartanburg, South Carolina, United States
    • Taylors, South Carolina, United States
  • South Dakota
    • Sioux Falls, South Dakota, United States
  • Tennessee
    • Bartlett, Tennessee, United States
    • Bristol, Tennessee, United States
    • Cleveland, Tennessee, United States
    • Franklin, Tennessee, United States
    • Germantown, Tennessee, United States
    • Jackson, Tennessee, United States
    • Johnson City, Tennessee, United States
    • Kingsport, Tennessee, United States
    • Knoxville, Tennessee, United States
    • Memphis, Tennessee, United States
    • Murfreesboro, Tennessee, United States
    • Nashville, Tennessee, United States
    • Oak Ridge, Tennessee, United States
  • Texas
    • Austin, Texas, United States
    • Beaumont, Texas, United States
    • Carrollton, Texas, United States
    • Dallas, Texas, United States
    • Denton, Texas, United States
    • Edinburg, Texas, United States
    • Fort Worth, Texas, United States
    • Grapevine, Texas, United States
    • Houston, Texas, United States
    • McKinney, Texas, United States
    • North Richland Hills, Texas, United States
    • Plano, Texas, United States
    • Saginaw, Texas, United States
    • San Antonio, Texas, United States
    • Southlake, Texas, United States
    • Temple, Texas, United States
    • Tomball, Texas, United States
  • Utah
    • Bountiful, Utah, United States
    • Ogden, Utah, United States
    • Salt Lake City, Utah, United States
  • Vermont
    • Bennington, Vermont, United States
    • South Burlington, Vermont, United States
  • Virginia
    • Burke, Virginia, United States
    • Charlottesville, Virginia, United States
    • Galax, Virginia, United States
    • Lakeridge, Virginia, United States
    • Manassas, Virginia, United States
    • Norfolk, Virginia, United States
    • Richmond, Virginia, United States
    • Roanoke, Virginia, United States
    • Suffolk, Virginia, United States
    • Virginia Beach, Virginia, United States
  • Washington
    • Everett, Washington, United States
    • Tacoma, Washington, United States
  • Wisconsin
    • Beloit, Wisconsin, United States
    • Green Bay, Wisconsin, United States
    • Madison, Wisconsin, United States
    • Manitowoc, Wisconsin, United States
    • Milwaukee, Wisconsin, United States
    • Waukesha, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.	Drug: Placebo; Alogliptin placebo matching tablets
Experimental: Alogliptin; Alogliptin 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.	Drug: Alogliptin; Alogliptin tablets; Other Names: Nesina®; SYR-322; SYR110322

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Cushman WC, Zannad F; EXAMINE Investigators. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013 Oct 3;369(14):1327-35. doi: 10.1056/NEJMoa1305889. Epub 2013 Sep 2.
• White WB, Bakris GL, Bergenstal RM, Cannon CP, Cushman WC, Fleck P, Heller S, Mehta C, Nissen SE, Perez A, Wilson C, Zannad F. EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J. 2011 Oct;162(4):620-626.e1. doi: 10.1016/j.ahj.2011.08.004. Epub 2011 Sep 14.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: August 28, 2009
• First Submitted That Met QC Criteria: August 28, 2009
• First Posted (Estimate): August 31, 2009

Study Record Updates

• Last Update Posted (Estimate): May 2, 2014
• Last Update Submitted That Met QC Criteria: April 15, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: stroke; Diabetes Mellitus; metabolic diseases; cardiovascular outcomes; Diabetes Mellitus - Type 2; heart attack; dipeptidyl-peptidase IV inhibitors; metabolic disorders; glucose metabolism disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Syndrome; Acute Coronary Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Alogliptin
• Other Study ID Numbers: SYR-322_402; U1111-1111-6825 (Registry Identifier: WHO); 2009-011222-34 (Registry Identifier: OsSC); JapicCTI-101246 (Registry Identifier: JapicCTI); DOH-27-0310-3047 (Registry Identifier: SANCTR); 09/H0709/63 (Registry Identifier: NRES); CTRI/2010/091/000046 (Registry Identifier: CTRI); NMRR-09-872-4471 (Registry Identifier: NMRR)