Supplementary Appendix

This appendix has been provided by the authors to give readers additional information about their work.

Supplement to: White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with
type 2 diabetes. N Engl J Med 2013. DOI: 10.1056/NEJMoa1305889
Appendix. EXAMINE Steering Committee, Data Safety Monitoring Committee, and
Cardiovascular Endpoints Committee Members, Takeda Clinical Support Teams, Lists
of Investigators and Location

Table of Contents
List of Investigators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Steering Committee Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Data Monitoring Committee Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Cardiovascular End Point Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Takeda Support Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Figure S1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Figure S2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Figure S3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Table S1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Table S2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Table S3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

1
List of Investigators:

Argentina: Jorge Aiub, Juan Albisu, Carlos Alvarez, Alfredo Astesiano, Raul Barcudi,

Mario Bendersky, Julio Bono, Betina Bustos, Luis Cartasegna, Orlando Caruso, Horacio

Casabe, Remo Castro, Hugo Colombo, Carlos Cuneo, Fernando Cura, Luis De Loredo,

Ricardo Dran, Horacio Fernandez, Jorge Garcia Pinna, Adrian Hrabar, Maria Klyver de

Saleme, Hugo Luquez, Ignacio Mackinnon, Laura Maffei, Claudio Majul, Marcelo

Mallagray, Javier Marino, Diego Martinez, Roberto Martingano, Daniel Nul, María Leonor

Parody, Jacqueline Petrucci, Mario Pieroni, Daniel Piskorz, Aldo Prado, Hugo Ramos, Jorge

Resk, Marcelo Rodriguez, Carlos Rojas, Rodolfo Sarjanovich, Alejandro Sarries, Horacio

Sessa, Sandra Silveiro, Maria Ines Sosa Liprandi, Jorge Tartaglione, Hugo Tonin, Julio

Vallejos, Santiago Vigo, Virginia Visco, Nestor Vita, Daniel Vogel, Oscar Vogelmann,

Cesar Zaidman, Pedro Zangroniz

Australia: David Colquhoun, Steven Coverdale, Steve Flecknoe-Brown, Chris Sing Loi Hii,

Philip Roberts-Thomson

Austria: Heinz Drexel, Anton Luger, Thomas Pieber

Belgium: Frank Cools, Johannes Ruige, Danny Schoors, Chris Vercammen, Bart Wollaert

Brazil: Fernando Alves da Costa, Celso Amodeo, Rejane Baggenstoss, Eduardo Barbosa,

Weimar Kunz Barroso de Souza, Roberto Bassan, Joao Lindolfo Borges, Roberto Botelho,

Maria Christiane Valeria Braile, Helio Castello, Jr, Carolina Chrisman, Fabio dos Santos,

Jose Faria Neto, Pedro Farsky, Alessandra Fernandes Da Costa, Fadlo Fraige Filho, Benito

Garbelini Jr, Maria Fernanda Garcia, Pedro Garzon, Artur Eduardo Guimaraes, Artur Herdy,

Mauro Hernandes, Sandra Hilgemberg, Miguel Hissa, Jose Antonio Jatene, Adrian Kormann,

Paulo Leaes, Felipe Lima, Hugo Roberto Lisboa, Lilia Maia, Francisco Maia da Silva,

2
Daniela Maldonado Franco, Jose Fernando Martin, Ana Medeiros, Yorghos Michalaros,

Andressa Miguel Leitao, Sergio Montenegro, Joao Moraes Junior, Marco Mota Gomes,

Maria Sanali Paiva, Dalton Precoma, Alvaro Rabelo, Gilmar Reis, Helder Reis, Paulo Rossi,

Wladmir Saporito, Rogerio Sarmento Leite, Ricardo Pereira Silva, Delcio Silva Junior,

Luciano Sousa, Antonio Carlos Sousa, Ricardo Ueda, Fabio Vilas-Boas, Marco Wainstein,

Alexandre Zago

Bulgaria: Mashka Angelova, Emilia Apostolova, Ivona Daskalova, Alexy Delchev, Kiril

Hristozov, Mariana Ilieva, Sneghina Kovacheva, Maria Lucheva, Margarita Temelkova,

Antoaneta Toneva, Vyara Videva, Emilina Vuchkova

Canada: Asaad Bakbak, Andre Carpentier, Yun Kai Chan, Asim Cheema, Guy Chouinard,

James Conway, Jean-Pierre Dery, Anthony Dowell, Andre Frechette, Marek Jakubowski,

Allan Kelly, Patrick Ma, Tun Zan Maung, Shamir Mehta, David Parker, Yves Pesant, Petr

Polasek, Thomas Ransom, Gurcharan Syan, Saul Vizel

Chile: Francisco Albornoz, Pablo Castro Galvez, Jorge Leonardo Cobos, Carlos Conejeros,

Mauricio D'Acuña Apablaza, Graciela Fajardo, Guillermo Illanes Brochet, Marcos Opazo

Lazcano, Christian Pincetti, Sergio Potthoff, Carlos Raffo, Victor Saavedra, Maria

Schnettler, Pablo Sepulveda, Benjamin Stockins, Margarita Vejar

Colombia: Jose Luis Accini, Carlos Hernan Cotes Aroca, Ricardo Leon Fernandez Ruiz,

Luis Alejandro Orozco Linares, Boris Eduardo Vesga Angarita

Croatia: Izet Aganovic, Jugoslav Bagatin, Silvija Canecki-Varzic, Dubravka Jurisic Erzen,

Aleksandar Knezevic, Andreja Maric, Goran Milicevic, Zeljko Popovic, Josip Rubes, Sonja

Slosic Weiss

3
Czech Republic: Irma Dresslerova, Jana Havelkova, Dusan Kucera, Josef Machacek, Jiri

Pumprla

Denmark: Ole May, Hans Perrild

Egypt: Magdy Abdel Aziz, Mahmoud El Badry, Mahmoud Hasanein

Finland: Juhani Airaksinen, Mika Laine, Kai Nyman, Saila Vikman

France: Jacques Bonnet, Meyer Elbaz, Patrick Henry, Francois Paillard, Catherine Petit,

Anne-Isabelle Tropeano

Germany: Thomas Behnke, Stefan Bornstein, Klaus Busch, Henning Ebelt, Marcus Faghih,

Hermann Fischer, Hubertus Heuer, Ralf Paschke, Tudor-Constantin Porner, Gerard

Tangerding, Hans-Friedrich Vöhringer

Great Britain: Karen Adamson, Kevin Beatt, Srikanth Bellary, John Chapman, Alastair

Cooke, Miles Fisher, Luigi Gnudi, Hugh Jones, Sudhesh Kumar, Dinesh Nagi, Keith

Oldroyd, Tristan Richardson, Douglas Robertson, Anthony Robinson, Ponnusamy

Saravanan, Adie Viljoen, John Wilding, Peter Wilkinson, Yuk-ki Wong

Greece: Christos Zoupas

Guatemala: Juan Arango, Jose Castellanos, Carlos Ceren Flores, Vinicio Corona, Arnoldo

Granados-Fuentes, Franklin Haase, Pablo Montenegro, Julio Humberto Palencia Prado,

Renato Villalobos

Hong Kong: Francis Chow, Shu Kin Li, June Li, Ping Yen Bryan Yan, Vincent Yeung

Hungary: Tatjana Abel, Amalia Benedek, Eniko Dezso, Mihaly Dudas, István Édes, Gabor

Fulop, Aranka Kovács, Geza Lupkovics, Béla Merkely, Andras Nagy, Andras Nagy, Tamas

Oroszlan, Attila Palinkas, Andras Papp, Jozsef Patkay, Eva Simon, Eva Sitkei, Adam Tabak,

János Tomcsányi

4
India: Jabir Abdullakutty, Atul Abhyankar, Umesh Akalkotkar, Thomas Alexander, Jaspal

Arneja, Naved Aslam, Pothineni Ramesh Babu, Byrapaneni Ramesh Babu, Darshan Banker,

Ganapati Bantwal, PR Bhimashankar, Rajneesh Kumar Calton, Manoj Chopda, Ajay Dande,

Sameer Dani, Neeta Deshpande, Niteen Deshpande, Dinesh Dhanwal, Aniruddha

Dharmadhikari, Milind Gadkari, Nitish Garg, Nitin Ghaisas, NK Goyal, Jugal Bihari Gupta,

Anil Jawahirani, Stigmon Joseph, Ravi Kumar, Mukund Kumble, A Mathavan, Atul Mathur,

Padnihare Purayil Mohanan, Abhilash Nair, Tiny Nair, Deepak Namjoshi, Robin Pinto, Guru

Prakash, R Purushotham, Srinivas Raju, Padmakumar Ramachandran, SS Ramesh, Bhaskara

Rao, Amancherla Ravikishore, G Rajashekar Reddy, Sanjeeb Roy, Nehal Sadhu, BKS

Sastry, Parvinder Singh, Arun Srinivas, Hemant Thacker, Sunil Thanvi, Joy Thomas

Israel: Faiad Adawi, Amir Bashkin, Josef Cohen, Ilana Harman-Boehm, Yonathan Hasin,

Tony Hayek, Zaza Iakobishvili, Amos Katz, Oscar Kracoff, Oscar Minuchin, Mady Moriel,

Morris Mosseri, Muhamad Omary, Julio Wainstein, Avraham Weiss, David Zeltser

Italy: Paolo Calabro, Giuseppe Derosa, Stefano Genovese, Salvatore Novo, Carlo Olivieri,

Piermarco Piatti, Roberto Violini, Massimo Volpe

Japan: Masayoshi Ajioka, Tetsuya Amano, Osamu Arasaki, Hiroyuki Daida, Kazuteru

Fujimoto, Hiroyuki Fujinaga, Shinichi Higashiue, Atsushi Hirohata, Shinobu Hosokawa,

Hiroyuki Ikefuji, Masayuki Inagaki, Harukazu Iseki, Masashi Iwabuchi, Toshiya Iwasaki,

Mikio Kakishita, Yousuke Katsuda, Kimiko Kawada, Kenji Kawajiri, Katsunori Kawamitsu,

Katsuyuki Kobayashi, Fumihiko Komada, Yasuo Komura, Masaharu Machida, Koji

Maemura, Taku Matsubara, Sunao Matsubayashi, Tomoaki Matsumoto, Naoki Matsumoto,

Tsutomu Mima, Nobuhide Miyamoto, Yukihiko Momiyama, Takafumi Morimoto, Marohito

Murakami, Eitaro Nakashima, Yawara Niijima, Toshiyuki Noda, Koichi Node, Akira

5
Nozaki, Tatsuya Nunohiro, Tomohiro Ogawa, Yasuhiro Ono, Takahiro Saeki, Shinichiro

Sakota, Satoru Sakuragi, Toyoshi Sasaki, Yasuhiro Sato, Atsushi Sueyoshi, Masahiro Suzuki,

Gen Takagi, Jun Tanabe, Seiichi Tanaka, Imun Tei, Masato Yamamoto, Kaoru Yanagihara

Korea: Taek Jong Hong, Hui-Kyung Jeon, Duk-Hyun Kang, Cheol Ho Kim, Dong-Soo Kim,

Hyun-Sook Kim, June Hong Kim, Soon Kil Kim, Woo-Shik Kim, Young-Kwon Kim, Sang-

Rok Lee, Kwan-Woo Lee, Hun-Sik Park, Wook Bum Pyun, Seung-Woon Rha, Junghan

Yoon, Kun-Ho Yoon

Kuwait: Abdullah Bennakhi

Latvia: Kristine Geldnere, Jelena Sokolova, Dace Teterovska

Lithuania: Violeta Dautaraite, Vaida Kakariekiene, Roma Kavaliauskiene, Alina

Kucinskiene, Jurate Lasiene, Narseta Mickuviene, Algirdas Palinauskas, Audrone Urboniene,

Birute Zilaitiene

Malaysia: Hasmannizar Abdul Manap, Imran Zainal Abidin, Siti Harnida Md Isa, Amir Md.

Khir, Kok Huan Ng, Florence Tan, Zurkurnai Yusof, Khalid Yusoff, Robaayah Zambahari

Mexico: Javier Aguila-Marin, Manuel Aguilera Real, Ricardo Alvarado-Ruiz, Humberto

Alvarez Lopez, Jose Arenas Leon, Edmundo Alfredo Bayram Llamas, Cesar Calvo Vargas,

Jorge Carrillo Calvillo, Manuel De los Rios Ibarra, Carlos Alberto Dominguez-Reyes,

Manuel Duarte, Eduardo Elizondo, Pedro Fajardo Campos, Guillermo Fanghanel-Salmon,

Sergio Figueroa Sauceda, Jose Gallegos Martinez, Elias Garcia-Cantu, Jose Angel Garza

Ruiz, Jose Gerardo Gonzalez Gonzalez, Manuel Guerrero Garza, Carlos Hernandez Herrera,

Carlos Hernandez Herrera, Jesus Hernandez Munuzuri, Hugo Hernandez-Garcia, Silvia

Jimenez Ramos, Hugo Laviada Molina, David Lopez Villezca, Efrain Montano-Gonzalez,

6
Luis Nevarez Ruiz, Gabriel Ramos Lopez, Raul Reyes Araiza, Abel Salazar-Gaytan,

Eduardo Salcido Vazquez, Hector Sanchez Mijangos, Lucas Solis Morales

New Zealand: Jocelyne Benatar, Paul Dixon, Kingsley Nirmalaraj, Ian Rosen, Russell Scott,

Simon Young

Peru: Ofelia Araoz Tarco, Luis Barreda Cáceres, Carmen Benites Lopez, Luis Camacho

Cosavalente, Edith Chavez Huapalla, Augusto Chois Malaga, Alex Copaja Flores, Julio

Farfan Aspilcueta, Wilson Gallardo Rojas, Alex Gallegos Cazorla, David Galvez Caballero,

Julio Garcia Matheus, Elizabeth Garrido Carrasco, Jorge Gomez Sanchez, Jose Hernandez

Zuniga, Libia Lu Galarreta, Alejandro Luna, Helard Manrique Hurtado, Boris Orihuela

Pastor, Rosa Maria Pando Alvarez, Javier Sanchez Povis, Pedro Torres Eguiluz, Angelica

Valdivia Portugal, Rolando Vargas Gonzales, Luis Zapata Rincon

Philippines: Grace Aquitania, Judy Theresa Fortinez, Angelita Go, Maria Honolina Gomez,

Ramoncito Habaluyas, Gabriel Jasul, Marie Magno, Carlo John Manalo, Roberto Mirasol,

Ellen Morales-Palomares, David Raymund Salvador, Rosa Allyn Sy, Louie Tirador, Christy

Yao

Poland: Malgorzata Arciszewska, Radoslaw Bartkowiak, Eugenia Czajkowska-Kaczmarek,

Robert Gil, Jacek Gniot, Krzysztof Janik, Marianna Janion, Krystyna Jaworska, Robert

Jozwa, Kalina Kawecka-Jaszcz, Teresa Kawka-Urbanek, Marek Kondys, Janusz Korecki,

Romuald Korzeniak, Alicja Kowalisko, Maria Krzeminska-Pakula, Jolanta Kwiecien,

Jadwiga Nessler, Piotr Odrowaz-Pieniazek, Marek Piepiorka, Marek Rajzer, Ewa

Skokowska, Janusz Spyra, Michal Sroka, Teresa Stasinska, Ireneusz Szymczyk, Iwona

Trznadel-Morawska, Andrzej Wysokinski

Portugal: Pedro Mateus, Pedro Matos, Jorge Mimoso, Pedro Monteiro

7
Puerto Rico: Baruch Caballero, Raul Garcia-Rinaldi, Elena Gonzalez, Ramon Ortiz-

Carrasquillo, Amaury Roman, Yolanda Sierra, Nestor Unger, Jose Vazquez-Tanus

Romania: Tom Alexandru, Mihaela Busegeanu, Doina Constanta Cozman, Simona Fica,

Bogdan Minescu, Magdalena Morosanu, Gabriela Doina Negrisanu, Ella Pintilei, Lavinia

Pop, Iosif Szilagyi, Iulia Teodorescu, Mirela Tomescu

Russia: Olga Barbarash, Galina Chumakova, Svetlana Churina, Sergey Dogadin, Irina

Dvoryashina, Valeria Esip, Maria Glezer, Ivan Gordeev, Alexander Gordienko, Nikolay

Gratsiansky, Elena Grineva, Niaz Khasanov, Victor Kostenko, Tatiana Meleshkevich, Vadim

Mikhin, Tatyana Morugova, Igor Motylev, Konstantin Nikolaev, Asya Ponomareva, Mikhail

Repin, Olga Reshetko, Sergey Shustov, Elena Shutemova, Yury Shvarts, Vladimir

Simanenkov, Konstantin Sobolev, Irina Sukmanova, Alexander Timofeev, Larisa Tsyba,

Galina Varvarina, Arkadiy Vertkin, Alexander Vishnevsky, Dmitry Volkov, Sergey

Vorobiev, Natalya Vorokhobina, Davyd Yakhontov, Elena Zonova, Konstantin Zrazhevskiy

Serbia: Svetozar Damjanovic, Dragan Djordjevic, Milan Pavlovic, Jovan Perunicic, Arsen

Ristic, Sinisa Stojkovic, Nebojsa Tasic

Slovakia: Nora Bolvanska, Ingrid Buganova, Katarina Dulkova, Andrej Dzupina, Peter

Fulop, Vladimir Gergel, Martin Kokles, Karol Micko, Peter Svoren, Miroslav Urban, Silvia

Vadinova, Anna Vargova

South Africa: Leslie Burgess, Kathleen Coetzee, Jacques Du Toit, Mashra Gani, Pankaj

Joshi, Puvanesveri Naiker, Hendrik Nortje, Mahomed Sarvan, Mary Seeber, Mirna Siebert,

Louis van Zyl, Holger Wellmann

Spain: Carlos Calvo, Jesus De la Hera, Luis De Teresa, Antonio Melero-Pita, Jordi Mesa,

Juan Parra Barona, Pedro Serrano, Alfonso Soto, Santiago Tofe

8
Sweden: Bjorn Hornestam, Anders Kempe, Ulf Rosenqvist, Erik Rydberg, Bengt-Olov

Tengmark, Ingemar Torstensson

Taiwan: Chwen-Tzuei Chang, Te-Lin Hsia, I-Chang Hsieh, Wen-Ter Lai, Chiung-Jen Wu

Thailand: Pisit Hutayanon, Natapong Kosachunhanun, Mongkol Marapracertsak, Chumpol

Piamsomboon, Samroeng Seekaew, Suphot Srimahachota, Pradub Sukhum, Swangjit

Suraamornkul, Puntip Tantiwong, Chaiyasith Wongvipaporn

Ukraine: Kateryna Amosova, Olga Barna, Andriy Bazylevych, Vadym Berenfus, Alexander

Dyadyk, Ivan Fushtey, Olga Gyrina, Mykola Iabluchanskyi, Oleksandr Karpenko, Igor

Kaydashev, Oleksii Korzh, Roman Kulynych, Olexandr Legkonogov, Boris Mankovsky,

Yuriy Mostovoy, Oleksandr Parkhomenko, Galyna Popik, Leonid Rudenko, Iurii Rudyk,

Sergii Shevchuk, Yuriy Sirenko, Yevgen Suprun, Nadiya Tryshchuk, Vira Tseluyko, Igor

Vakaliuk

United Arab Emirates: Wael Al Mahmeed

United States: Roger Acheatel, Anwar Ahmad, Saleem Akbar, Faiq Akhter, Abdulhay

Albirini, Arnold Alexander, Bassam Al-Joundi, Tammam Al-Joundi, Gregory Allen, Joseph

Aloi, Odilon Alvarado, Opada Alzohaili, Corey Anderson, Anwar Arastu, Charles Arena,

Georges Argoud, Mehrdad Ariani, Chander Arora, Vivek Awasty, Barbara Barker, Otis

Barnum, Anthony J. Bartkowiak, Joshua Barzilay, Phillip Behrens, Mario Belledonne,

Bradford Bergman, William Bilnoski, John Bisognano, Stephen Bissette, Edwin Blumberg,

Nagadeh Bonabi, Arden Bradley, Cristian Breton, Martin Britos, Vasti Broadstone, Matthew

Budoff, Mark Burge, Samuel Butman, Mary Carroll, Krishnan Challappa, Vinaya Chepuri,

Richard Cherlin, Deanna Cheung, Peter Coats, John Collins, Humberto Cruz, Nizar Daboul,

Greg Damberg, William David, Julius Dean, Eric Dedeke, Wasim Deeb, Joseph DeHaven,

9
Adrian Dobs, Timothy Donelan, Johnny Dy, Gary Dykstra, Howard Eisen, Neil Farris, Peter

Fattal, Norman Fishman, Malcom Foster, Sonja Fredrickson, Nashwa Gabra, John Gabriel,

Lionel Gatien, Stephen Giddings, Burton Ginsberg, Sanford Gips, Mariela Glandt, Aaron

Goldfein, Murray Gordon, Randy Gould, Ronald Graf, Bruce Graham, Mark Graves, Paul

Grena, Richard Hahn, Dale Hamilton, Glenn Hamroff, Forrest Hanke, Ihsan Haque, James

Harper, Jr, Anthony Harris, Sharon Harris, Bruce Henson, David Hermanns, William

Herndon, Vernon Hershberger, Daniel Hyman, Steven Isserman, Bruce Iteld, Moshir Jacob,

Naseem Jaffrani, Aamir Jamal, David Johnson, Glover Johnson, Edo Kaluski, Robert Keller,

Dean Kereiakes, Muhammad Khan, Salman Khan, Misal Khan, Michael Klein, Thomas

Knutson, Elie Korban, Marc Kozinn, Philip Kraft, James Kroeze, Eugene Kukuy, Ellis

Lader, Aristotelis Laliotis, Charles Lambert, Jr, Charles Landau, Kashif Latif, Kwan Lee, F.

Lester, David Levenson, Dennis Levinson, Derek Lewis, Marc Litt, Ronald Littlefield, Eric

Lo, Charles Lovell, Sharan Mahal, Satyaprakash Makam, Mustafa Mandviwala, Isam Marar,

Bassem Masri, Steven Mattson, Maureen Mays, Frank McGrew, Mark Meengs, Frank

Mikell, Michael Miller, Francisco Miranda, David Moll, Pramod Multani, Karan

Munuswamy, Mani Nallasivan, Lee Nayles, Stephen Ong, Theodore Pacheco, Henry Paez,

Shailendra Patel, Roland Phillips, Brien Pierpont, Jeereddi Prasad, Edward Quinlan, Jun

Quion, Mansoor Qureshi, Aref Rahman, Marina Raikhel, Kodangudi Ramanathan, Preet

Randhawa, Ram Ravi, Rajneesh Reddy, Marc Rendell, Kyle Rickner, Kenneth Rictor, Jose

Rivas, Paul Rosenblit, Julio Rosenstock, Steven Ross, Abraham Salacata, Mehrdrad Saririan,

Susan Schima, Aron Schlau, John Schmedtje, Cranford Scott, David Scott, Antonio Serru-

Paez, Rakesh Shah, Anil Shah, Emanuel Shaoulian, Mansur Shomali, Jay Shubrook, Kevin

Silver, Sanjay Singh, John Speer, Jewel Stevens, Stanley Stringam, Andrew Taussig, Angela

10
Taylor, Howard Tee, Gilbert Teixeira, Absalom Tilley, Edward Toggart, Marcel Twahirwa,

Dennis Unks, Babak Vakili, Kishor Vora, Xiangbing Wang, Alberta Warner, Franklin

Wefald, Bradley Weinberg, Debra Weinstein, Lindsey White, Patricia Wu, Tsunehiro

Yasuda, Shahram Yazdani, Cornelius Yetman, Stuart Zarich, James Zebrack

11
Steering Committee:

William B. White, M.D., Farmington, CT (Chair); George L. Bakris, M.D., Chicago, IL;

Richard M. Bergenstal, M.D., Minneapolis, MN; Christopher P. Cannon, M.D., Boston, MA;

William C. Cushman, M.D., Memphis, TN; Penny Fleck, M.T., M.B.A. (ex officio),

Deerfield, IL; Simon Heller, M.D., Sheffield, England, UK; Stuart Kupfer, M.D. (ex officio),

Deerfield, IL; Cyrus Mehta, Ph.D., Cambridge, MA; Steven E. Nissen, M.D., Cleveland, OH;

Alfonso Perez, M.D., (ex officio), Deerfield, IL; and Faiez Zannad, M.D., Ph.D., Nancy,

France.

Data Monitoring Committee: Vivian A. Fonseca, M.D., New Orleans, LA (Chair); Peter A.

McCullough, M.D., M.P.H., Southfield, MI; Cyrus Desouza, M.B.B.S., Omaha, NE; David

C. Goff, M.D., Ph.D.; Winston-Salem, NC, Frank E. Harrell, Jr. Ph.D., Nashville, TN.

Cardiovascular Endpoints Committee (Cleveland, OH): Venu Menon, M.D., (Chair);

Cathy Sila, M.D.; Vidyasagar Kalahasti, M.D.; Salim Ahmed, M.D.; Firas Al Solaiman,

M.D.; Mosi Bennett, M.D.; Matthew Cavender, M.D.; Barbara Heil, M.D.; Irene Katzan,

M.D.; Peter Monteleone, M.D.; Bridget O’Brien, M.D.; Santosh Oommen, M.D.; Todd Senn,

M.D.; Jitendra Sharma, M.D.; Brian Stegman, M.D.; Ken Uchino, M.D.; Edwin Zishiri,

M.D.; Narcis Pasca; Kimberly Brown; Tambria Scebbi; Ilija Atanasovski.

Takeda Support Team

Clinical Science: Maggie McCue, M.S., R.D.; Janet Streit, M.S.; Richard Oh, M.D.; Orlando

Bueno, M.D., PhD; Douglas Lee, M.D.; Riccardo Camisasca, M.D.; Yuuko Miyata.

Clinical Operations: Anne Rubin, Nyree Williamson, Sanjay Vara, Kraig Keeter, Ben Ross,

Amy de los Reyes, Julie Donnelly, Sini Koshy-Hunt, Brian Beers, Stephen Black, Maria

Buckley, Maria Ephrem, Bill Riley, Nicola West, Mark Harre, Roger Hsieh, Keji Oshinyemi,

12
Yumiko Oka, Nobuto Matsui, Minhtri Hoang, Cassandra Doyle, Maria Koziol.

Biostatistics and Data Management: Hung Lam, Ph.D.; Anthony Edmonds, M.S.; Willow

Azooz, Charlie Cao, Ph.D.

Pharmacovigilance: Denny Kim, M.D., Amy Boeshaar, R.N., Alex Dewindt, M.D.; Kim

Nicholson, R.N.; Neila Smith, M.D., Michie Hisada, M.D., Sarah Harding, M.D., Clive

Cannon M.D., Norihito Yoshioka, Kiran Gujral-Sandhu.

Project Management: Jason Gans, M.B.A.; Christopher Gresk.

Publications: Michelle R. Kujawski, Ph.D.

Regulatory: Allison Villinski, Sandy Cosner, R.Ph., Clint Johannsen, Nina Barchha,

PharmD, and Beth Knapp

13
Figure S1. EXAMINE Regions and Countries.

North America
 Canada  United States

Mexico, Central/ South America

 Argentina  Chile  Guatemala  Peru
 Brazil  Colombia  Mexico  Puerto Rico

Western Europe/ Australia/ New Eastern Europe/Africa

Zealand/ Middle East
 Australia  Italy  Bulgaria  Poland
 Austria  Kuwait  Croatia  Romania
 Belgium  New Zealand  Czech Rep.  Russia
 Denmark  Portugal  Egypt  Serbia
 Finland  Spain  Hungary  Slovakia
 France  Sweden  Latvia  S. Africa
 Germany  UAE  Lithuania  Ukraine
 Greece  United Kingdom
 Israel

Asia Pacific Region

 Hong Kong  Japan  Malaysia  Taiwan
 India  Republic of Korea  Philippines  Thailand

14
Figure S2. Cumulative Kaplan-Meier Estimates of the Time to the First Adjudicated Occurrence of the Secondary End Point
(cardiovascular death, myocardial infarction, stroke and urgent revascularization for unstable angina)

Hazard ratio, 0.95 (*one-sided repeated CI bound, 1.14)

15
Figure S3. Hazard Ratio for the Primary Outcome in Subgroups

16
17
Figure S3. Rates of the primary end point of cardiovascular death, myocardial infarction, and stroke with alogliptin and placebo
across several major subgroups uncorrected for multiple comparisons. P < 0.05 denotes significant interaction. * one-sided repeated
confidence interval using alpha = 0.01

18
Table S1. Baseline and Changes From Baseline for Lipoproteins
Placebo Alogliptin
Lipid Parameter (n=2679) (n=2701)
Total Cholesterol (mg/dL)
n 2679 2701
Baseline
Mean (±SD) 154.8 (43.5) 153.9 (44.2)
n 2624 2650
Last visit: Change from Baseline
Mean (±SD) 13.1 (45.2) 12.2 (43.1)
HDL Cholesterol (mg/dL)
n 2679 2700
Baseline
Mean (±SD) 43.1 (10.3) 43.2 (10.8)
n 2623 2648
Last visit: Change from Baseline
Mean (±SD) 1.7 (8.8) 1.5 (8.9)
LDL Cholesterol (mg/dL)
n 2642 2668
Baseline
Mean (±SD) 78.9 (34.6) 78.4 (34.9)
n 2583 2609
Last visit: Change from Baseline
Mean (±SD) 8.6 (35.7) 7.9 (33.6)
Triglycerides (mg/dL)
n 2679 2701
Baseline
Mean (±SD) 166.4 (106.0) 162.7 (101.9)
n 2624 2650
Last visit: Change from Baseline Mean (±SD) 17.1 (154.6) 15.7 (132.3)

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Supplementary Table 2. Other Safety End Points
Alogliptin
Placebo (n=2679) (n=2701) P value*
Any Serious Adverse Event, 952 (35.5) 907 (33.6) 0.14
Serious hypoglycemia** 16 (0.6) 18 (0.7) 0.86
Any Adverse Event 2111 (78.8) 2160 (80.0) 0.30
Any hypoglycemia ** 173 (6.5) 181 (6.7) 0.74
Pancreatitis†
Acute 8 (0.3) 12 (0.4) 0.50
Chronic 4 (0.1) 5 (0.2) 1.00
Angioedema 13 (0.5) 17 (0.6) 0.58
Malignancy 51 (1.9) 55 (2.0) 0.77

Renal dialysis 22 (0.8) 24 (0.9) 0.88

Laboratory Results
Serum aminotransferases >3 times upper limit of
normal at any time during trial
Alanine aminotransferase‡ 46 (1.7) 64 (2.4) 0.10
§
Aspartate aminotransferase 43 (1.6) 48 (1.8) 0.67
* **
P values were calculated by Fisher’s exact test with no adjustment for multiple comparisons; hypoglycemia was reported by site
investigators; †terms included pancreatitis acute, relapsing pancreatitis, and pancreatitis; ‡The upper limit of normal for the alanine
aminotransferase was 25 U/L. §The upper limit of normal for aspartate aminotransferase was 22 U/L

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Table S3. Mean Change in Estimated Glomerular Filtration Rate According to
Baseline Kidney Function

Kidney Estimated GFR Placebo Alogliptin

Function (MDRD formula)
Category at
Baseline
eGFR > 90 N = 440 N = 399
ml/min
Baseline eGFR 103.2 104.8
∆ from baseline -4.5 -6.7
eGFR < 90 and > N = 1446 N = 1530
60 ml/min
Baseline eGFR 75.0 74.6
∆ from baseline 1.0 0.6
eGFR < 60 and > N = 714 N = 694
30 ml/min
Baseline eGFR 48.4 48.5
∆ from baseline 2.1 1.1
eGFR < 30 N = 79 N = 78
ml/min
Baseline eGFR 22.9 22.6
∆ from baseline 1.6 0.2
eGFR=estimated glomerular filtration rate calculated by the MDRD formula in milliliters per
minute divided by the square of the height in meters x 1.73; ∆=change

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