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1. Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes: The FIDELIO-DKD Subgroup from China

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Zhang, Haitao, Xie, Jingyuan, Hao, Chuanming, Li, Xuemei, Zhu, Dalong, Zheng, Hongguang, Xu, Xudong, Mo, Zhaohui, Lu, Weiping, Lu, Yibing, Wu, Chaoqing, Tong, Nanwei, Wang, Li, and Liu, Zhihong

Abstract

Background:This prespecified subgroup analysis of the FIDELIO-DKD trial aimed to evaluate the efficacy and safety of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM) in China. Methods:372 participants were recruited from 67 centers in China and randomized 1:1 to oral finerenone or placebo with standard therapy for T2DM. The primary composite outcome included kidney failure, sustained decrease of estimated glomerular filtration rate ≥40% from baseline over at least 4 weeks, or renal death. The key secondary composite outcome included death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Results:After a median follow-up of 30 months, the finerenone group showed a relative risk reduction (RRR) of 41% (hazard ratio [HR] = 0.59, 95% confidence interval [CI], 0.39–0.88; p= 0.009) for the primary composite outcome compared with placebo, consistent across its components with treatment benefits with finerenone. Based on an absolute between-group difference of 12.2% after 30 months, the number of patients who needed to be treated with finerenone to prevent one primary outcome event was eight (95% CI: 4–84). For the key secondary composite outcome, the finerenone group showed a RRR of 25% (HR = 0.75, 95% CI, 0.38–1.48; p= 0.408). Adverse events were similar between the two groups. The effects of finerenone on blood pressure were modest. No gynecomastia events were reported in the study. Hyperkalemia leading to discontinuation occurred in eight (4.3%) and two (1.1%) participants in the finerenone and control groups, respectively. The incidence of acute kidney injury was comparable between the two groups (1.6% vs. 1.6%). Conclusions:Finerenone resulted in lower risks of CKD progression than placebo and a balanced safety profile in Chinese patients with CKD and T2DM.

Published
2023
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2. Outcomes with Finerenone in Participants with Stage 4 CKD and Type 2 Diabetes

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Sarafidis, Pantelis, Agarwal, Rajiv, Pitt, Bertram, Wanner, Christoph, Filippatos, Gerasimos, Boletis, John, Tuttle, Katherine R., Ruilope, Luis M., Rossing, Peter, Toto, Robert, Anker, Stefan D., Liu, Zhi-Hong, Joseph, Amer, Ahlers, Christiane, Brinker, Meike, Lawatscheck, Robert, Bakris, George, Aizenberg, Diego, Bartolacci, Inés, Besada, Diego, Bittar, Julio, Chahin, Mariano, Elbert, Alicia, Gelersztein, Elizabeth, Liberman, Alberto, Maffei, Laura, Manghi, Federico Pérez, Sanabria, Hugo, Vallejos, Augusto, Viñes, Gloria, Wassermann, Alfredo, Abhayaratna, Walter, Acharya, Shamasunder, Ekinci, Elif, Lee, Darren, MacIsaac, Richard, Mah, Peak Mann, Nelson, Craig, Packham, David, Pape, Alexia, Roger, Simon, Stephenson, Hugo, Suranyi, Michael, Wittert, Gary, Vale, Elizabeth, Colman, Peter, Colquhoun, David, Ellis, Chris, Joshua, Kim, Pedagogos, Eugenia, Regal, Paul, Topliss, Duncan, Vandeleur, James, Verjans, Johan, Wittert, Gary, Wynne, Katie-Jane, Clodi, Martin, Ebenbichler, Christoph, Fliesser-Görzer, Evelyn, Hanusch, Ursula, Krebs, Michael, Lhotta, Karl, Ludvik, Bernhard, Mayer, Gert, Neudorfer, Peter, Paulweber, Bernhard, Prager, Rudolf, Preiß, Wolfgang, Prischl, Friedrich, Schernthaner, Gerit-Holger, Sourij, Harald, Wiesholzer, Martin, Drexel, Heinz, Oberbauer, Rainer, Schönherr, Hans-Robert, Doubel, Peter, Engelen, Wendy, Gillard, Pieter, Hougardy, Jean-Michel, Krzesinski, Jean-Marie, Maes, Bart, Speeckaert, Marijn, Stas, Koen, van Gaal, Luc, Vanbelleghem, Hilde, Duyck, Francis, Scheen, André, Antunes, Daniela, Botelho, Roberto, Brito, Claudia, Canani, Luis, Canziani, Maria Eugenia, Cerqueira, Maria, de Paula, Rogerio, Eliaschewitz, Freddy, Figueiredo, Carlos Eduardo, Forti, Adriana, Hissa, Miguel, Leite, Emerson Lima Maurilo, Noronha, Irene, Paolino, Bruno, Paschoalin, Nathalia, Paschoalin, Raphael, Filho, Roberto Pecoits, Pereira, Marcio, Portes, Evandro, Precoma, Dalton, Rea, Rosangela, Riella, Miguel, Salles, Joao Eduardo, Vasconcellos, Eduardo, Vencio, Sergio, Bacci, Marcelo, Maia, Lilia, Villacorta, Aline, Apostolova, Emiliya, Boshnyashka, Radostina, Farah, Ghassan, Georgiev, Dimitar, Gushterova, Valentina, Klyuchkova, Neli, Lucheva, Mariya, Manova, Petya, Minkova, Dotska, Nonchev, Boyan, Pichmanova, Mariyana, Prakova, Zhulieta, Rangelov, Rangel, Rashkov, Rosen, Stanchev, Pavel, Stoyanovska-Elencheva, Bilyana, Tagarev, Zhivko, Temelkova-Kurktschieva, Theodora, Vasileva, Svetla, Yoncheva-Mihaylova, Mariana, Marinchev, Angel, Miteva, Mariya, Barre, Paul, Carlson, Brian, Conway, James, Cournoyer, Serge, Dumas, Richard, Fikry, Sameh, Goluch, Richard, Hamet, Pavel, Hart, Randolph, Henein, Sam, Liutkus, Joanne, Madore, Francois, Martinho, Valdemar, Mazza, Giuseppe, McFarlane, Philip, Keefe, Dennis O′, Peterson, Sean, Schwartz, Daniel, Shu, Daniel, Steele, Andrew, Tellier, Guy, Tennankore, Karthik, Tobe, Sheldon, Tsoukas, George, Tytus, Richard, Vitou, Louise, Walsh, Michael, Weisnagel, Stanley, Wilderman, Igor, Yale, Jean-Francois, El Boreky, Fadia, Kelly, Alan, Leiter, Lawrence, Teitelbaum, Ivor, Cobos, Jorge, Godoy, Juan, González, Fernando, Lobos, Sergio, Palma, Juan Carlos, Prieto Dominguez, Juan Carlos, Reyes, Eliana, Romero, Carmen, Saavedra, Victor, Vega, Mario, Medina, Marcelo, Varleta, Paola, Bu, Ruifang, Cai, Hanqing, Chen, Nan, Chen, Qinkai, Chen, Dejun, Cheng, Jinluo, Dong, Youping, Dong, Junwu, Guan, Tianjun, Hao, Chuanming, Huang, Wen, Jiang, Fangfang, Lei, Minxiang, Li, Ling, Li, Zhonghe, Li, Xuemei, Li, Jingmei, Li, Yan, Liang, Xinling, Liang, Bo, Liu, Fang, Liu, Yinghong, Liu, Yuantao, Liu, Zhihong, Long, Gang, Lu, Guoyuan, Lu, Weiping, Lu, Yibing, Luo, Ping, Ma, Jianhua, Mo, Zhaohui, Niu, Jianying, Peng, Ai, Shen, Jiansong, Shen, Feixia, Shi, Bingyin, Su, Qing, Sun, Zhuxing, Tang, Shuifu, Tong, Nanwei, Wang, Hao, Wang, Xinjun, Wang, Guixia, Wang, Jianqin, Wang, Yangang, Wang, Li, Wei, Jiali, Wu, Tianfeng, Wu, Chaoqing, Xing, Changying, Xiong, Fei, Xu, Xudong, Xu, Ning, Yan, Tiekun, Yang, Jinkui, Yin, Aiping, Zeng, Longyi, Zhang, Hao, Zhang, Yanlin, Zhang, Ying, Zhao, Wenjing, Zhao, Zhiquan, Zheng, Hongguang, Zhong, Ling, Zhu, Dalong, Zhuang, Yongze, Du, Yuming, Fang, Yi, Guo, Weiying, Jiang, Sheng, Kuang, Jian, Li, Dongmei, Li, Hongmei, Li, Yinan, Li, Yuxiu, Liu, Jian, Liu, Yu, Miao, Heng, Peng, Wen, Wang, Lihua, Xu, Mingtong, Zhong, Liyong, Zhu, Jun, Arango, Clara, Barrera, Sandra, López, Nelly Beltrán, Benitez, Diego, Blanco, Guillermo, Cadena, Andrés, Coronel, Julian, Cure, Carlos, Durán, Carlos, González, Alexander, Guzmán, Gustavo, Hernández, Eric, Ibarra, Jaime, Jaramillo, Carlos, Jaramillo, Nicolás, Kattah, William, Molina, Dora, Sánchez, Gregorio, Terront, Mónica, Trujillo, Freddy, Urina, Miguel, Vargas, Ruben, Villegas, Iván, Yupanqui, Hernán, Arcos, Edgar, Aroca, Gustavo, Barreto, Germán, Bermudez, Andres, Botero, Rodrigo, Cárdenas, Tatiana, Figueroa, Wilmer, Jaramillo, Mónica, Liévano, Manuel, López, Mónica, Molina, Dora, Rosero, Ricardo, Trillos, Pedro, Alferi, Dino, Brada, Michal, Brezina, Jiri, Bucek, Petr, Edelsberger, Tomas, Gulakova, Drahomira, Zapletalova, Jitka Hasalova, Hola, Olga, Hornova, Lucie, Houdova, Jana, Hrmova, Helena, Karasek, David, Kopecka, Sarka, Kovar, Richard, Krcova, Eva, Kuchar, Jiri, Kutejova, Vlasta, Lubanda, Hana, Matyasek, Ivo, Mokrejsova, Magdalena, Okenka, Libor, Prazny, Martin, Pumprla, Jiri, Tomanek, Pavel, Andersen, Ulla, Andries, Alin, Bech, Jesper, Faber, Jens, Gislason, Gunnar, Hangaard, Jørgen, Pacyk, Grzegorz Jaroslaw, Juhl, Claus, Krarup, Thure, Lindhardt, Morten, Madsbad, Sten, Nielsen, Joan, Pedersen-Bjergaard, Ulrik, Poulsen, Per, Rasmussen, Ole, Rossing, Peter, Schousboe, Karoline, Gram, Jeppe, Lauridsen, Thomas, Pedersen, Erling, Thorsteinsson, Birger, Flöjt, Päivi, Honkasalo, Mikko, Honkasalo, Mikko, Humaloja, Kari, Kananen, Kristiina, Kantola, Ilkka, Koistinen, Arvo, Korsoff, Pirkko, Lahtela, Jorma, Nieminen, Sakari, Nieminen, Tuomo, Sadeharju, Karita, Strand, Jorma, Sulosaari, Sakari, Cariou, Bertrand, Chantrel, François, Clavel, Sylvaine, Combe, Christian, Fauvel, Jean-Pierre, Gallouj, Karim, Gouet, Didier, Guerci, Bruno, Guerrot, Dominique, Hourmant, Maryvonne, Klein, Alexandre, Mariat, Christophe, Marre, Michel, Mesbah, Rafik, Le Meur, Yannick, Monier, Arnaud, Moranne, Olivier, Roussel, Ronan, Serusclat, Pierre, Vendrely, Benoit, Verges, Bruno, Zaoui, Philippe, Axthelm, Christoph, Bergmann, Andreas, Birkenfeld, Andreas L., Braun, Hermann, Busch, Klaus, Contzen, Christel, Degenhardt, Stefan, Derwahl, Karl, Giebel, Thomas, Hagenow, Andreas, Haller, Hermann, Hasslacher, Christoph, Horacek, Thomas, Jungmair, Wolfgang, Kloos, Christof, Koch, Thorsten, Krüger, Thilo, Mühlfeld, Anja, Müller, Joachim, Pfützner, Andreas, Pistrosch, Frank, Rinke, Andrea, Rose, Ludger, Rump, Lars, Schettler, Volker, Schiefke, Ingolf, Schlichthaar, Heike, Schröppel, Bernd, Schöll, Norbert, Schubert, Kristin, Schürholz, Thomas, Sigal, Helena, Stemler, Lutz, Strack, Georg, Täschner, Heidrun, Toursarkissian, Nicole, Tschöpe, Diethelm, Ulmer, Achim, van der Giet, Markus, Wanner, Christoph, Winkelmann, Bernhard R., Boletis, Ioannis, Dimitriadis, George, Hatziagelaki, Erifili, Iatrou, Christos, Ioannidis, Ioannis, Kounadi, Theodora, Makriniotou, Ioanna, Papadopoulou, Dorothea, Papagianni, Aikaterini, Passadakis, Ploumis, Piaditis, George, Stefanidis, Ioannis, Ip, Tai Pang, Lee, Paul, Andrea Luk, On Yan, Ma, Ronald, Chow, Wing Sun, Wang, Angela, Yeung, Vincent, Bajcsi, Dora, Danos, Peter, Harcsa, Eleonora, Kalina, Akos, Kazup, Szilvia, Keltai, Katalin, Kirschner, Robert, Kiss, Julianna, Kovacs, Laszlo, Lamboy, Beata, Literati-Nagy, Botond, Mileder, Margit, Nagy, Laszlo, Noori, Ebrahim, Nyirati, Gabor, Petro, Gizella, Schneider, Karoly, Simon, Judit, Szocs, Albert, Vasas, Szilard, Wudi, Krisztina, Zilahi, Zsolt, Zsom, Marianna, Eustace, Joe, Holian, John, Reddan, Donal, Meara, Yvonne O′, Abramof Ness, Rosane, Adawi, Faiad, Armaly, Zaher, Atar, Shaul, Bashkin, Amir, Ben Chetrit, Sydney, Yanay, Noa Berar, Chernin, Gil, Darawsha, Mahmud, Efrati, Shai, Elias, Mazen, Farber, Evgeny, Glandt, Mariela, Grossman, Ehud, Halabi, Majdi, Harman-Boehm, Ilana, Khazim, Khaled, Liberty, Idit, Minuchin, Oscar, Mosenzon, Ofri, Nakhoul, Farid, Nimer, Assy, Schwartz, Doron, Wainstein, Julio, Yagil, Yoram, Zukermann, Robert, Avogaro, Angelo, Battaglia, Giovanni Giorgio, Bevilacqua, Maurizio Tiziano, Bonora, Enzo, Bossi, Carlo Antonio, Calabrò, Paolo, Cavalot, Franco Luigi, Cimino, Roberto, Cozzolino, Mario Gennaro, David, Salvatore, Emdin, Michele, Fiaccadori, Enrico, Fiorina, Paolo, Giorda, Carlo Bruno, Gregorini, Maria Cristina, La Manna, Gaetano, Maggi, Davide Carlo, Manti, Roberta, Meregalli, Giancarla, Pani, Antonello, Parvanova, Aneliy Ilieva, Perico, Norberto, Piatti, PierMarco, Pisani, Antonio, Pontiroli, Antonio Ettore, Ponzani, Paola, Santorelli, Gennaro, Santoro, Domenico, Scanziani, Renzo, Teatini, Ugo, Tonolo, Giancarlo, Trevisan, Roberto, Veronelli, Anna Maria, Viviani, Giorgio Luciano, Araki, Hideo, Bando, Yukihiro, Ebisui, Osamu, Fujita, Naruhiro, Fukasawa, Hirotaka, Furuya, Ryuichi, Hamamoto, Yoshiyuki, Hamasaki, Akihiro, Hasegawa, Kotaro, Hatazaki, Masahiro, Hayashi, Terumasa, Higashi, Takayuki, Hirohata, Yoshihide, Horinouchi, Shuji, Hoshi, Ayumu, Imoto, Hirofumi, Inagaki, Akemi, Inagaki, Masayuki, Inaguma, Daijo, Inoue, Toshihiko, Ishii, Masao, Ishiko, Tamayo, Isono, Motohide, Jinnouchi, Hideaki, Kanai, Hidetoshi, Kanda, Daisuke, Kanehara, Hideo, Kashima, Masayuki, Kataoka, Yuko, Katayama, Shigehiro, Kato, Kiyoe, Katsuki, Takeshi, Kawamitsu, Katsunori, Kawasaki, Satsuki, Kikuchi, Fumi, Kikuchi, Hidetoshi, Kishimoto, Rui, Kobayashi, Kunihisa, Koide, Junko, Komi, Rieko, Kubota, Miyuki, Kuriya, Genpei, Kurose, Takeshi, Kusano, Yoshiro, Hajime, Maeda, Matsubayashi, Sunao, Matsumoto, Kazunari, Matsumura, Naoya, Matsuo, Yasuto, Matsuoka, Naoki, Miyaoka, Hiroaki, Miyata, Satoshi, Morita, Takeshi, Murakami, Isao, Murao, Satoshi, Nakamura, Udai, Nakayama, Mikihiro, Nakazawa, Jun, Nohara, Sakae, Nomiyama, Takashi, Noritake, Masayuki, Oda, Yoshiaki, Ogiwara, Takayuki, Ohashi, Hiroshi, Okamoto, Hideki, Okino, Shinichi, Osonoi, Takeshi, Sasaki, Nobuhiro, Sayo, Yoshitaka, Sekigami, Taiji, Shibasaki, Taro, Shibata, Hirotaka, Shimoyama, Tatsushi, Shinoda, Junji, Sobajima, Hiroshi, Sugitatsu, Kazuya, Sugiura, Toshiyuki, Sugiyama, Toru, Suzuki, Daisuke, Suzuki, Hiroyuki, Suzuki, Masaaki, Takeda, Asami, Tanaka, Asami, Tanaka, Seiichi, Tsunematsu, Izumi, Ueda, Yasuo, Uekihara, Soichi, Ujihara, Makoto, Yajima, Ken, Yamada, Daishiro, Yamada, Masayo, Yamagata, Kazuo, Yamakawa, Ken, Yamakawa, Fumiko, Yamasaki, Yoshimitsu, Yambe, Yuko, Yanagida, Taihei, Yanai, Hidekatsu, Yanase, Toshihiko, Yasuda, Tetsuyuki, Kriauciuniene, Dovile, Lasiene, Jurate, Navickas, Antanas, Radzeviciene, Lina, Urbanaviciene, Egle, Urbonas, Gediminas, Velaviciene, Audrone, Abd Ghani, Rohana, Aziz, Nor Azizah, Lee, Li Yuan, Loh, Chek Loong, Ali, Norhaliza Mohd, Noor, Nurain Mohd, Fatnoon Nik Ahmad, Nik Nur, Ratnasingam, Jeyakantha, Halimi Bin Wan Hasan, Wan Hasnul, Izani Wan Mohamed, Wan Mohd, Khir, Rizmy Najme, Mohamad, Masni, Alexander Tan, Tong Boon, Avila Pardo, Sandro, Adrian, Miriam Bastidas, Wong, Alfredo Chew, Escobedo de la Peña, Jorge, Salmón, Guillermo Fanghänel, Gálvez, Guillermo González, Ochoa, Ramiro Gutiérrez, Santana, Saúl Irizar, Rovalo, Magdalena Madero, Machado, Gustavo Méndez, Ruiz, Luis Nevarez, Ibarra, Denisse Ramos, López, Gabriel Ramos, Reyna, Leobardo Sauque, Ortiz, Gustavo Solache, Ortiz, Rafael Valdez, Mesa, Juan Villagordoa, Salazar, Melchor Alpizar, Hernández, Pedro García, González, José, Soto, José Lazcano, Mendoza, Arturo Saldaña, Santana, Sergio Irizar, Vilchis, Elvira González, Bakker, R.C., Barendregt, J.N.M., Boonstra, A.H., Bos, Willem, Brouwer, C.B., Buren, M. van, Gansevoort, Ron, Kooy, Adriaan, Krekels, Marielle, Leendert, Ruud J.M. van, Lieverse, Louis A.G., Luik, P.T., Penne, E. Lars, Gregoor, Peter Smak, Vogt, Liffert, Born, Bert-Jan van den, Baker, John, Crawford, Veronica, Cutfield, Rick, Dunn, Peter, Krebs, Jeremy, Nirmalaraj, Kingsley, Scott, Russell, Smuts, Nine, Titchener, Janet, Eriksen, Erik, Finnes, Trine, Høivik, Hans, Karlsson, Thomas, Munk, Peter Scott, Radtke, Maria, Risberg, Knut, Rocke, Jan, Solnør, Leidulv, Stenehjem, Aud-Eldrid, Tafjord, Anne-Beathe, Asprusten, Emil, Hagemeier, Robert, Høye, Kjetil, Selsås, Hilde, Thorup, Frode, Wium, Cecilie, Pamugas, Glenda, Panelo, Araceli, Perez, Ronald, Tanque, Maribel, Tirador, Louie, Villa, Michael, Bautista, Albert, Catindig, Elizabeth, Manalo, Carlo, Mirasol, Roberto, Butrymowicz, Patrycja, Ciechanowski, Kazimierz, Cieslik, Grazyna, Franek, Edward, Gumprecht, Janusz, Hoffmann, Michal, Krzykowska, Jolanta, Kurnatowska, Ilona, Landa, Katarzyna, Madrzejewski, Adam, Madziarska, Katarzyna, Mazur, Stanislaw, Napora, Piotr, Nowicki, Michal, Ocicka-Kozakiewicz, Anna, Rewerska, Barbara, Rusicka, Teresa, Ruxer, Jan, Skokowska, Ewa, Stankiewicz, Andrzej, Stompor, Tomasz, Tiuryn-Petrulewicz, Agnieszka, Wasilewska, Katarzyna, Wierusz-Wysocka, Bogna, Wnetrzak-Michalska, Renata, Jedynasty, Krystyna, Anand, Izabela Sein, Almeida, Edgar, Ballesteros, Rosa, Barreto, Carlos, Beirao, Idalina, Birne, Rita, Esteves, Cesar, Guia, Jose, Heitor, Susana, Marques, Olinda, Melo, Pedro, Nolasco, Fernando, Pereira, Amalia, Roque, Cristina, Rosario, Francisco, Silva, Gil, Silva, Ana, Teixeira e Costa, Fernando, Lobos, Ana Vila, Alves, Ana Rita, Brandao, Ilidio, Carvalho, Rui, Coelho, Joao, Lourenco, Ana, Matos, Pedro, Rosario, Vanisa, Neves, Joao Sergio, Cortes-Maisonet, Gregorio, Roman-Miranda, Amaury, Brito-Peguero, Yudit, Colon-Vega, Gildred, Albota, Adrian, Bala, Cornelia, Barbonta, Hortensia, Caceaune, Elena, Catrinoui, Doina, Constantin, Ciprian, Dumitrescu, Adriana, Mindrescu, Nicoleta, Mistode, Cristina, Negrisanu, Gabriela, Onaca, Adriana, Paveliu, Silvia, Pintilei, Ella, Pop, Lavinia, Popa, Amorin, Popescu, Alexandrina, Radulian, Gabriela, Szilagyi, Iosif, Turcu, Liana, Vacaru, Georgeta, Vlad, Adrian, Filimon, Adriana, Veresiu, Ioan, Antsiferov, Mikhail, Arkhipov, Mikhail, Babkin, Andrey, Barbarash, Olga, Baranov, Vitaliy, Chernyavskaya, Elena, Demko, Arkadiy, Dreval, Alexander, Edin, Anton, Ermakova, Polina, Fadeev, Valentin, Galyavich, Albert, Gaysina, Leyla, Gordeev, Ivan, Ipatko, Irina, Kalashnikova, Marina, Khalimov, Yuriy, Klimontov, Vadim, Kobalava, Zhanna, Kosmacheva, Elena, Koziolova, Natalya, Sergey Levashov, Lyudmila Kvitkova, Libis, Roman, Marasaev, Vyacheslav, Malykh, Natalia, Martynenko, Vladimir, Malyutina, Sofya, Merai, Imad, Mkrtumyan, Ashot, Nechaeva, Galina, Petunina, Nina, Palyutin, Shamil, Pimenov, Leonid, Rechkova, Elena, Rodionova, Tatyana, Rymar, Oksana, Sardinov, Ruslan, Semenova, Olga, Sherenkov, Alexander, Solovev, Oleg, Smolyarchuk, Elena, Strongin, Leonid, Ukhanova, Olga, Verlan, Nadezhda, Vorokhobina, Natalya, Yakhontov, Davyd, Yakushin, Sergey, Zakharova, Elena, Zalevskaya, Alsu, Zanozina, Olga, Zhdanova, Elena, Zhukova, Larisa, Zykova, Tatyana, Argunova, Yulia, Nikolaev, Konstantin, Villevalde, Svetlana, Fang Sum, Chee, Suhail, Sufi Muhummad, San Tan, Ru, Vathsala, Anantharaman, Wong, Edmund, Bee, Yong Mong, Babikova, Jana, Buganova, Ingrid, Dzupina, Andrej, Ochodnicka, Zuzana, Sosovec, Dalibor, Spodniakova, Denisa, Minarik, Peter, Ahmed, Fayzal, Amod, Aslam, Bhana, Sindeep, Distiller, Larry, Jansen van Rensburg, Dirkie, Joshi, Mukesh, Joshi, Shaifali, Lakha, Deepak, Mitha, Essack, Podgorski, Gracjan, Ranjith, Naresh, Rayner, Brian, Rheeder, Paul, Sarvan, Mohamed, Seeber, Mary, Siebert, Heidi, Tayob, Mohammed, Trokis, Julien, Urbach, Dorothea, van Zyl, Louis, Jansen van Rensburg, Dirkie, Choi, Bum-Soon, Choi, Moon Gi, Chung, ChoonHee, Hwang, YouCheol, Kim, ChongHwa, Kim, InJoo, Kim, JaeHyeon, Kim, SinGon, Kim, SungGyun, Kim, Tae Hee, Lee, WooJe, Lee, ByungWan, Lee, Kang Wook, Oh, Kook-Hwan, Oh, Ji Eun, Oh, Yun Kyu, Oh, Dong-Jin, Park, Junbeom, Shin, Seok Joon, Sung, Su-Ah, Yu, Jae Myung, Chung, HyeSoo, Huh, Ji Hye, Kang, JunGoo, Kim, ChulSik, Kim, HyeSoon, Kim, NamHoon, Lim, Soo, Cho, Young Min, Park, Cheol Young, Agraz, Irene, Ampudia, Francisco Javier, Bouarich, Hanane, Calero, Francesca, Castro, Cristina, Guldris, Secundino Cigarrán, Garrit, Josep Cruzado, de Álvaro, Fernando, Galcerán, Josep, Albarrán, Olga González, Jaras, Julio Hernández, Ibernón, Meritxell, Deben, Francisco Martínez, Ma, Esteban, Dolores Martínez, Pascual Izuel, José María, Martins, Judith, Mediavilla, Juan, Michán, Alfredo, Santos, Julio Pascual, Poch, Esteban, Rusillo, Manuel Polaina, Juan, Carlos Sánchez, Olmo, Rafael Santamaría, Segura de la Morena, José Julián, Soto, Alfonso, Troya, Maribel, Castro, Fernando Cereto, Fernández, Pablo Gómez, Sánchez, Laura Fuentes, Moya, Mercedes González, Marrero, Domingo Hernández, Maroto, Gonzalo Piedrola, Redón, Josep, Seron, Daniel, Bruchfeld, Annette, Curiac, Dan, Eliasson, Ken, Frank, Malin, Guron, Gregor, Hellberg, Olof, Hellgren, Margareta, Larnefeldt, Hans, Lindholm, Carl-Johan, Löndahl, Magnus, Rein-Hedin, Erik, Soveri, Inga, Spaak, Jonas, Tengmark, Bengt-Olov, Lif-Tiberg, Cornelia, Månflod, Johan, Nguyen, Han, Ackermann, Daniel, Bilz, Stefan, Burnier, Michel, Forster, Christian, Kalbermatter, Stefan, Kistler, Andreas, Pechère-Bertschi, Antoinette, Schultes, Bernd, Laimer, Markus, Rudofsky, Gottfried, Strey, Christopher, Wuerzner, Gregoire, Chang, Chiz-Tzung, Hung, Cheng-Chieh, Jiang, Ju-Ying, Lee, Chien-Te, Lin, Shuei-Liong, Tarng, Der-Cherng, Tu, Shih-Te, Wu, Mai-Szu, Wu, Ming-Ju, Chuang, Lee-Ming, Deerochanawong, Chaicharn, Kitiyakara, Chagriya, Ophascharoensuk, Vuddhidej, Pongchaiyakul, Chatlert, Satirapoj, Bancha, Kosachunhanan, Natapong, Sritara, Piyamitr, Eren, Necmi, Gul, Ibrahim, Gulel, Okan, Kocyigit, Ismail, Kumbasar, Abdulbaki, Sahin, Idris, Sari, Ramazan, Sayin, Burak, Tavli, Talat, Ustundag, Sedat, Yenicerioglu, Yavuz, Badak, Ozer, Cayli, Murat, Oguz, Aytekin, Ozdogan, Oner, Sari, Ibrahim, Temizhan, Ahmet, Tigen, Mustafa, Turk, Ugur, Yilmaz, Huseyin, Yilmaz, Mehmet, Bondarets, Iryna, Botsyurko, Volodymyr, Chernikova, Viktoriia, Donets, Oleksandra, Fushtey, Ivan, Grachova, Mariia, Isayeva, Anna, Kogut, Dmytro, Komisarenko, Julia, Kravchun, Nonna, Malyar, Kateryna, Mankovsky, Borys, Martynyuk, Liliya, Maslyanko, Vitaliy, Myshanych, Halyna, Pererva, Larysa, Pertseva, Nataliia, Serhiyenko, Oleksandr, Smirnov, Ivan, Sokolova, Liubov, Stryzhak, Vasyl, Vlasenko, Maryna, Isayeva, Ganna, Larin, Oleksandr, AbouSaleh, Ahmad, Barratt, Jonathan, Dang, Cuong, Kahal, Hassan, Kirk, Adam, Kilvert, Anne, Kon, Sui Phi, McCafferty, Kieran, Patel, Dipesh, Rice, Sam, Vijayaraman, Arutchelvam, Wong, Yuk-ki, Gibson, Martin, Wahba, Mona, Zaidi, Reza, Bilous, Rudy, Johnson, Andrew, Kalathil, Dhanya, Kilvert, Anne, Kyriakidou, Christina, Mathew, Amit, Mukhtar, Rasha, Munsoor, Imrozia, Poterajlo, Anton, Swift, Pauline, Acosta, Idalia, Adams, Atoya, Adler, Sharon, Ajani, Dilawar, Ali, Slamat, Alicic, Radica, Al-Karadsheh, Amer, Alla, Sreedhara, Allison, D., Andrawis, Nabil, Arif, Ahmed, Awad, Ahmed, Azizad, Masoud, Bahrami, Michael, Bansal, Shweta, Barag, Steven, Barakzoy, Ahmad, Barney, Mark, Barzilay, Joshua, Bashir, Khalid, Bautista, Jose, Beddhu, Srinivasan, Belo, Diogo, Benjamin, Sabrina, Berenji, Ramin, Bhargava, Anuj, Birriel, Jose, Brietzke, Stephen, Brosius, Frank, Brusco, Osvaldo, Burgner, Anna, Busch, Robert, Canadas, Rafael, Caramori, Maria, Cardona, Jose, Case, Christopher, Cruz, Humberto, Dandillaya, Ramprasad, Dawoud, Dalia, Din, Zia, Dixon, Bradley, Doshi, Ankur, Drakakis, James, El Shahawy, Mahfouz, El-Meanawy, Ashraf, El-Shahawy, Mohammed, Evans, John, Fadda, George, Farooq, Umar, Fernando, Roland, Fink, Raymond, First, Brian, Fitz-Patrick, David, Flack, John, Fluck, Patrick, Fogelfeld, Leon, Fonseca, Vivian, Frias, Juan, Galphin, Claude, Garcia-Mayol, Luis, Goldstein, Gary, Gonzalez, Edgar, Gonzalez-Abreu, Francisco, Gore, Ashwini, Grant, David, Habwe, Violet, Hamilton, Maxine, Hammoud, Jamal, Handelsman, Stuart, Hartman, Israel, Heigerick, Glenn, Henry, Andrew, Hernandez, German, Hernandez-Cassis, Carlos, Herrera, Carlos, Hertel, Joachim, Huang, Wenyu, Iglesias, Rogelio, Iranmanesh, Ali, Jackson, Timothy, Jain, Mahendra, Jamerson, Kenneth, Johnson, Karen, Judd, Eric, Kaplan, Joshua, Kayali, Zeid, Khan, Bobby, Khan, Muhammad, Kharait, Sourabh, Kirkman, M. Sue, Kopyt, Nelson, Kotzker, Wayne, Kovesdy, Csaba, Kreit, Camil, Krishna, Arvind, Kronfli, Saeed, Lee, Keung, LeJeune, Derek, Lemus, Brenda, Leon-Forero, Carlos, Linfert, Douglas, Lora, Henry, Lurie, Alexander, Maddukuri, Geetha, Magno, Alexander, Maletz, Louis, Mandayam, Sreedhar, Markell, Mariana, Mayfield, Ronald, Mbogua, Caroline, McMullen, Dierdre, Meisner, Carl, Minton, Stephen, Mocherla, Bharat, Mohandas, Rajesh, Montero, Manuel, Moustafa, Moustafa, Nadkarni, Salil, Nakhle, Samer, Navarro, Jesus, Neyra, Nilda, Nica, Romanita, Nicol, Philip, Norwood, Paul, Numrungroad, Visal, Donovan, Richard O′, Odugbesan, A., Paoli-Bruno, Jorge, Parikh, Samir, Patel, Rakesh, Peixoto, Aldo, Pergola, Pablo, Perlman, Alan, Pettis, Karlton, Pisoni, Roberto, Ponduchi, Mirela, Posada, Jorge, Prabhakar, Sharma, Radhakrishnan, Jai, Rahman, Mahboob, Raina, Rupesh, Rastogi, Anjay, Reisin, Efrain, Rendell, Marc, Robertson, David, Rocco, Michael, Romeu, Hugo, Rosas, Sylvia, Rosenfeld, Jack, Ross, Dennis, Rothman, Jeffrey, Rudolph, Lance, Ruhullah, Yusuf, Ruoff, Gary, Ryu, Jeffrey, Sahani, Mandeep, Sam, Ramin, Samuels, Garfield, Sanchez, William, Santos, Vladimir, Satko, Scott, Saxena, Sanjeev, Scott, David, Seco, Gilberto, Seek, Melvin, Serota, Harvey, Shafi, Tariq, Shahid, Nauman, Shanik, Michael, Sharma, Santosh, Sinha, Arjun, Smelser, James, Smith, Mark, Soe, Kyaw, Solomon, Richard, Soroka, Eugene, Soufer, Joseph, Spinowitz, Bruce, Spry, Leslie, Suarez, Rosa, Subramanian, Bala, Szerlip, Harold, Tamirisa, Aparna, Thomson, Stephen, Tran, Tuan-Huy, Treger, Richard, Trullenque, Gretel, Turk, Thomas, Umpierrez, Guillermo, Urbach, Daniel, Valdes, Martin, Valika, Shujauddin, Vega, Damaris, Weissman, Peter, Whaley-Connell, Adam, Winston, Jonathan, Wise, Jonathan, Wynne, Alan, Zeig, Steven, Abdel-Rahman, Emaad, Abreu, Edel, Awad, Alaa, Bahri, Nader, Bertsch, John, Bleich, David, Bornfreund, Jonathan, Brar, Harjeet, Brian, Susan, Brinson, Cynthia, Bruschetta, Humberto, Carpio, Jose, Cohen, Steven, Cosby, John, Dhanireddy, Soni, Diaz, Jorge, Dunn, Fredrick, Eppanapally, Sabitha, Fayad, Joseph, Goel, Archana, Govindaraju, Kanakadurga, Halpern, Stephen, Jones, Audrey, Kaye, William, Knight, Herbert, Koch, Stanley, Kohli, Nandini, Lastra, Guido, Lerman, Sam, Loredo, Jorge, Lovre, Dragana, Mandviwala, Mustafa, Martin, Earl, Meyer, Jill, Murray, John, Oliver, David, Oparil, Suzanne, Penabad, Jesus, Pereira, Isabel, Popeil, Larry, Quesada, Gonzalo, Ramanathan, Kodangudi, Ramos-Gonez, Luis, Rastegar, Mandana, Rastogi, Padmashri, Rondon, Juan, Roy-Chaudhury, Prabir, Smith, David, Williamson, Don, Womack, Catherine, Yamout, Hala, Yuryev, Michael, Chu, Phuong, Van Hoang, Lam, Khanh, Tran, Phi Nga, Nguyen Thi, Son, Pham Nguyen, Tran, Lan Phuong, Le, Thuy Khuong, Nguyen, Boi Ngoc, Nguyen, Thao, Nui, Nguyen Minh, Nam, Tran Quang, and Tran, Kim Chi

Published
2023
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3. Effects of metformin versus glipizide on cardiovascular outcomes in patients with type 2 diabetes and coronary artery disease

Author

Hong, Jie, Zhang, Yifei, Lai, Shenghan, Lv, Ankang, Su, Qing, Dong, Yan, Zhou, Zhiguang, Tang, Weili, Zhao, Jiajun, Cui, Lianqun, Zou, Dajin, Wang, Dawang, Li, Hong, Liu, Chao, Wu, Guoting, Shen, Jie, Zhu, Dalong, Wang, Weiqing, Shen, Weifeng, and Ning, Guang

Subjects
Mortality -- Maryland -- China -- Analysis, Type 2 diabetes -- Patient outcomes -- Care and treatment -- Analysis, Diabetics -- Patient outcomes -- Care and treatment -- Analysis, Glipizide -- Analysis, Health
Abstract

OBJECTIVE--The two major classes of antidiabetic drugs, sulfonylureas and metformin, may differentially affect macrovascular complications and mortality in diabetic patients. We compared the long-term effects of glipizide and metformin on [...]

Published
2013
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4. Diabetic ketoacidosis at diagnosis influences complete remission after treatment with hematopoietic stem cell transplantation in adolescents with type 1 diabetes

Author

Gu, Weiqiong, Hu, Jiong, Wang, Weiqing, Li, Lirong, Tang, Wei, Sun, Shouyue, Cui, Weijuan, Ye, Lei, Zhang, Yifei, Hong, Jie, Zhu, Dalong, and Ning, Guang

Subjects
Ketoacidosis -- Research, Medical research, Cyclophosphamide -- Research, Diabetes -- Research, Teenagers, Stem cells -- Transplantation, Stem cell research, Medicine, Experimental, Diabetic acidosis -- Research, Diabetes therapy, Type 1 diabetes -- Research, Hematopoietic stem cells -- Transplantation, Youth, Diabetics, Health
Abstract

OBJECTIVE--To determine if autologous nonmyeloablative hematopoietic stem cell transplantation (AHSCT) was beneficial for type 1 diabetic adolescents with diabetic ketoacidosis (DKA) at diagnosis. RESEARCH DESIGN AND METHODS--We enrolled 28 patients [...]

Published
2012
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5. Short-term intensive therapy in newly diagnosed type 2 diabetes partially restores both insulin sensitivity and β-cell function in subjects with long-term remission

Author

Hu, Yun, Li, Lirong, Xu, Yu, Yu, Tingting, Tong, Guoyu, Huang, Hong, Bi, Yan, Weng, Jianping, and Zhu, Dalong

Subjects
Diabetes therapy, Diabetes -- Research, Insulin resistance -- Care and treatment, Pancreatic beta cells, Insulin, Blood sugar, Type 2 diabetes -- Care and treatment, Health
Abstract

OBJECTIVE--To examine the effect of intensive glycemic control therapy (IT) on insulin sensitivity and β-cell function in newly diagnosed type 2 diabetic patients compared with subjects with normal glucose tolerance [...]

Published
2011
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6. Biphasic insulin aspart 30 three times daily is more effective than a twice-daily regimen, without increasing hypoglycemia, in Chinese subjects with type 2 diabetes inadequately controlled on oral antidiabetes drugs

Author

Yang, Wenying, Ji, Qiuhe, Zhu, Dalong, Yang, Jinkui, Chen, Lulu, Liu, Zhimin, Yu, Demin, and Yan, Li

Subjects
Diabetes therapy, Insulin -- Dosage and administration, Blood sugar, Type 2 diabetes -- Drug therapy, Health, Drug therapy, Dosage and administration
Abstract

OBJECTIVE--To assess the efficacy and safety of twice- and thrice-daily biphasic insulin aspart 30 (BIAsp 30) in Chinese subjects with type 2 diabetes inadequately controlled with oral antidiabetes drugs (OADs). [...]

Published
2008

7. Dorzagliatin add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial

Author

Yang, Wenying, Zhu, Dalong, Gan, Shenglian, Dong, Xiaolin, Su, Junping, Li, Wenhui, Jiang, Hongwei, Zhao, Wenjuan, Yao, Minxiu, Song, Weihong, Lu, Yibing, Zhang, Xiuzhen, Li, Huifang, Wang, Guixia, Qiu, Wei, Yuan, Guoyue, Ma, Jianhua, Li, Wei, Li, Ziling, Wang, Xiaoyue, Zeng, Jiao’e, Yang, Zhou, Liu, Jingdong, Liang, Yongqian, Lu, Song, Zhang, Huili, Liu, Hui, Liu, Ping, Fan, Kuanlu, Jiang, Xiaozhen, Li, Yufeng, Su, Qing, Ning, Tao, Tan, Huiwen, An, Zhenmei, Jiang, Zhaoshun, Liu, Lijun, Zhou, Zunhai, Zhang, Qiu, Li, Xuefeng, Shan, Zhongyan, Xue, Yaoming, Mao, Hong, Shi, Lixin, Ye, Shandong, Zhang, Xiaomei, Sun, Jiao, Li, Ping, Yang, Tao, Li, Feng, Lin, Jingna, Zhang, Zhinong, Zhao, Ying, Li, Ruonan, Guo, Xiaohui, Yao, Qi, Lu, Weiping, Qu, Shen, Li, Hongmei, Tan, Liling, Wang, Wenbo, Yao, Yongli, Chen, Daoxiong, Li, Yulan, Gao, Jialin, Hu, Wen, Fei, Xiaoqiang, Wu, Tianfeng, Dong, Song, Jin, Wenlong, Li, Chenzhong, Zhao, Dong, Feng, Bo, Zhao, Yu, Zhang, Yi, Li, Xiaoying, and Chen, Li

Abstract

Metformin, the first-line therapy for type 2 diabetes (T2D), decreases hepatic glucose production and reduces fasting plasma glucose levels. Dorzagliatin, a dual-acting orally bioavailable glucokinase activator targeting both the pancreas and liver glucokinase, decreases postprandial glucose in patients with T2D. In this randomized, double-blind, placebo-controlled phase 3 trial, the efficacy and safety of dorzagliatin as an add-on therapy to metformin were assessed in patients with T2D who had inadequate glycemic control using metformin alone. Eligible patients with T2D (n= 767) were randomly assigned to receive dorzagliatin or placebo (1:1 ratio) as an add-on to metformin (1,500 mg per day) for 24 weeks of double-blind treatment, followed by 28 weeks of open-label treatment with dorzagliatin for all patients. The primary efficacy endpoint was the change in glycated hemoglobin (HbA1c) levels from baseline to week 24, and safety was assessed throughout the trial. At week 24, the least-squares mean change from baseline in HbA1c (95% confidence interval (CI)) was −1.02% (−1.11, −0.93) in the dorzagliatin group and −0.36% (−0.45, −0.26) in the placebo group (estimated treatment difference, −0.66%; 95% CI: −0.79, −0.53; P< 0.0001). The incidence of adverse events was similar between groups. There were no severe hypoglycemia events or drug-related serious adverse events in the dorzagliatin and metformin combined therapy group. In patients with T2D who experienced inadequate glycemic control with metformin alone, dorzagliatin resulted in effective glycemic control with good tolerability and safety profile (NCT03141073).

Published
2022
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8. Dorzagliatin in drug-naïve patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial

Author

Zhu, Dalong, Li, Xiaoying, Ma, Jianhua, Zeng, Jiao’e, Gan, Shenglian, Dong, Xiaolin, Yang, Jing, Lin, Xiaohong, Cai, Hanqing, Song, Weihong, Li, Xuefeng, Zhang, Keqin, Zhang, Qiu, Lu, Yibing, Bu, Ruifang, Shao, Huige, Wang, Guixia, Yuan, Guoyue, Ran, Xingwu, Liao, Lin, Zhao, Wenjuan, Li, Ping, Sun, Li, Shi, Lixin, Jiang, Zhaoshun, Xue, Yaoming, Jiang, Hongwei, Li, Quanmin, Li, Zongbao, Fu, Maoxiong, Liang, Zerong, Guo, Lian, Liu, Ming, Xu, Chun, Li, Wenhui, Yu, Xuefeng, Qin, Guijun, Yang, Zhou, Su, Benli, Zeng, Longyi, Geng, Houfa, Shi, Yongquan, Zhao, Yu, Zhang, Yi, Yang, Wenying, and Chen, Li

Abstract

Improving glucose sensitivity remains an unmet medical need in treating type 2 diabetes (T2D). Dorzagliatin is a dual-acting, orally bioavailable glucokinase activator that enhances glucokinase activity in a glucose-dependent manner, improves glucose-stimulated insulin secretion and demonstrates effects on glycemic control in patients with T2D. We report the findings of a randomized, double-blind, placebo-controlled phase 3 clinical trial to evaluate the efficacy and safety of dorzagliatin in patients with T2D. Eligible drug-naïve patients with T2D (n= 463) were randomly assigned to the dorzagliatin or placebo group at a ratio of 2:1 for 24 weeks of double-blind treatment, followed by 28 weeks of open-label treatment with dorzagliatin for all patients. The primary efficacy endpoint was the change in glycated hemoglobin from baseline to week 24. Safety was assessed throughout the trial. At week 24, the least-squares mean change in glycated hemoglobin from baseline (95% confidence interval) was −1.07% (−1.19%, −0.95%) in the dorzagliatin group and −0.50% (−0.68%, −0.32%) in the placebo group (estimated treatment difference, −0.57%; 95% confidence interval: −0.79%, −0.36%; P< 0.001). The incidence of adverse events was similar between the two groups. There were no severe hypoglycemia events or drug-related serious adverse events in the dorzagliatin group. In summary, dorzagliatin improved glycemic control in drug-naïve patients with T2D and showed a good tolerability and safety profile.

Published
2022
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10. Dorzagliatin monotherapy in Chinese patients with type 2 diabetes: a dose-ranging, randomised, double-blind, placebo-controlled, phase 2 study

Author

Zhu, Dalong, Gan, Shenglian, Liu, Yu, Ma, Jianhua, Dong, Xiaolin, Song, Weihong, Zeng, Jiao'e, Wang, Guixia, Zhao, Wenjuan, Zhang, Qiu, Li, Yukun, Fang, Hui, Lv, Xiaofeng, Shi, Yongquan, Tian, Haoming, Ji, Linong, Gao, Xin, Zhang, Lihui, Bao, Yuqian, Lei, Minxiang, Li, Ling, Zeng, Longyi, Li, Xiaoying, Hou, Xinghua, Zhao, Yu, Hu, Tianxin, Ge, Xiaoyun, Zhao, Guiyu, Li, Yongguo, Zhang, Yi, and Chen, Li

Abstract

Glucokinase acts as a glucose sensor in the pancreas and a glucose processor in the liver, and has a central role in glucose homoeostasis. Dorzagliatin is a new, dual-acting, allosteric glucokinase activator that targets both pancreatic and hepatic glucokinases. Dorzagliatin has good pharmacokinetic and pharmacodynamic properties in humans, and provides effective 24-h glycaemic control and improves glucose sensitivity in patients with type 2 diabetes. We aimed to assess the efficacy and safety of dorzagliatin monotherapy at different doses in Chinese patients with type 2 diabetes.

Published
2018
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11. Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial

Author

Xu, Wen, Mu, Yiming, Zhao, Jiajun, Zhu, Dalong, Ji, Qiuhe, Zhou, Zhiguang, Yao, Bin, Mao, Anhua, Engel, Samuel, Zhao, Bin, Bi, Yan, Zeng, Longyi, Ran, Xingwu, Lu, Juming, Ji, Linong, Yang, Wenying, Jia, Weiping, and Weng, Jianping

Abstract

Despite the current guideline’s recommendation of a timely stepwise intensification therapy, the “clinical inertia”, termed as the delayed treatment intensification, commonly exists in the real world, which may be partly due to the relatively little substantial evidence and no clear consensus regarding the efficacy and safety of triple oral agents in patients inadequately controlled with dual therapy. In this clinical trial performed in 237 centers in China, 5,535 type 2 diabetic patients inadequately controlled by previous therapies were treated with a stable metformin/sitagliptin dual therapy for 20 weeks. The patients who did not reach the glycated hemoglobin A1c (HbA1c) goal were then further randomized into glimepiride, gliclazide, repaglinide, or acarbose group for an additional 24-week triple therapy. A mean HbA1c reduction of 0.85% was observed when sitagliptin was added to the patients inadequately controlled with metformin in 16 weeks. Further HbA1c reductions in the 24-week triple therapy stage were 0.65% in glimepiride group, 0.70% in gliclazide group, 0.61% in repaglinide group, and 0.45% in acarbose group. The non-inferiority criterion for primary hypotheses was met for gliclazide and repaglinide, but not for acarbose, compared with glimepiride, when added to metformin/sitagliptin dual therapy. The incidences of adverse events (AEs) were 29.2% in the dual therapy stage and 30.3% in the triple therapy stage. Metformin/sitagliptin as baseline therapy, with the addition of a third oral antihyperglycemic agent, including glimepiride, gliclazide, repaglinide, or acarbose, was effective, safe and well-tolerated for achieving an HbA1c <7.0% goal in type 2 diabetic patients inadequately controlled with previous therapies. The timely augmentation of up to three oral antihyperglycemic agents is valid and of important clinical benefit to prevent patients from exposure to unnecessarily prolonged hyperglycemia.

Published
2017
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12. The heterogeneity of islet autoantibodies and the progression of islet failure in type 1 diabetic patients

Author

Liu, Jin, Bian, Lingling, Ji, Li, Chen, Yang, Chen, Heng, Gu, Yong, Ma, Bingqin, Gu, Wei, Xu, Xinyu, Shi, Yun, Wang, Jian, Zhu, Dalong, Sun, Zilin, Ma, Jianhua, Jin, Hui, Shi, Xing, Miao, Heng, Xin, Bing, Zhu, Yan, Zhang, Zhenwen, Bu, Ruifang, Xu, Lan, Shi, Guangde, Tang, Wei, Li, Wei, Zhou, Dongmei, Liang, Jun, Cheng, Xingbo, Shi, Bimin, Dong, Jixiang, Hu, Ji, Fang, Chen, Zhong, Shao, Yu, Weinan, Lu, Weiping, Wu, Chenguang, Qian, Li, Yu, Jiancheng, Gao, Jialin, Fei, Xiaoqiang, Zhang, Qingqing, Wang, Xueqin, Cui, Shiwei, Cheng, Jinluo, Xu, Ning, Wang, Guofeng, Han, Guoqing, Xu, Chunrong, Xie, Yun, An, Minmin, Zhang, Wei, Wang, Zhixiao, Cai, Yun, Fu, Qi, Fu, Yu, Zheng, Shuai, Yang, Fan, Hu, Qingfang, Dai, Hao, Jin, Yu, Zhang, Zheng, Xu, Kuanfeng, Li, Yifan, Shen, Jie, Zhou, Hongwen, He, Wei, Zheng, Xuqin, Han, Xiao, Yu, Liping, She, Jinxiong, Zhang, Mei, and Yang, Tao

Abstract

Type 1 diabetes mellitus is heterogeneous in many facets. The patients suffered from type 1 diabetes present several levels of islet function as well as variable number and type of islet-specific autoantibodies. This study was to investigate prevalence and heterogeneity of the islet autoantibodies and clinical phenotypes of type 1 diabetes mellitus; and also discussed the process of islet failure and its risk factors in Chinese type 1 diabetic patients. A total of 1,291 type 1 diabetic patients were enrolled in this study. Demographic information was collected. Laboratory tests including mixed-meal tolerance test, human leukocyte antigen alleles, hemoglobinA1c, lipids, thyroid function and islet autoantibodies were conducted. The frequency of islet-specific autoantibody in newly diagnosed T1DM patients (duration shorter than half year) was 73% in East China. According to binary logistic regressions, autoantibody positivity, longer duration and lower Body Mass Index were the risk factors of islet failure. As the disease developed, autoantibodies against glutamic acid decarboxylase declined as well as the other two autoantibodies against zinc transporter 8 and islet antigen 2. The decrease of autoantibodies was positively correlated with aggressive beta cell destruction. Autoantibodies can facilitate the identification of classic T1DM from other subtypes and predict the progression of islet failure. As there were obvious heterogeneity in autoantibodies and clinical manifestation in different phenotypes of the disease, we should take more factors into consideration when identifying type 1 diabetes mellitus.

Published
2016
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13. Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism

Author

Zhang, Manna, Tong, Guoyu, Liu, Yanling, Mu, Yiming, Weng, Jianping, Xue, Yaoming, Luo, Zuojie, Xue, Yuanming, Shi, Lixin, Wu, Xueyan, Sun, Shouyue, Zhu, Yanhua, Cao, Ying, Zhang, Jie, Huang, Hong, Niu, Ben, Li, Hong, Guo, Qinghua, Gao, Yan, Li, Zhibin, Ning, Guang, Zhu, Dalong, and Li, Xiaoying

Abstract

Context:Gonadotropin therapy using a human chorionic gonadotropin (hCG) and FSH preparation is an effective regimen in inducing masculinization and spermatogenesis in men with idiopathic hypogonadotropic hypogonadism (IHH). However, the high cost of medication and frequent injections affect compliance.Objective:The aim of this study was to determine the efficacy of sequential use of highly purified urinary FSH (uFSH)/hCG in men with IHH.Design and Setting:A randomized, open-label, prospective, controlled noninferiority trial with an 18-month follow-up was conducted in 9 tertiary hospitals.Patients and Intervention:A total of 67 Chinese men with IHH were randomly allocated into group A receiving continual uFSH (75 U, 3 times a week) and hCG (2000 U, twice a week) injection and group B receiving sequential uFSH (75 U, 3 times a week every other 3 months) and hCG (2000 U, twice a week) injection.Main Outcome Measure:The primary outcome was the proportion of subjects with a sperm concentration of ≥1.0 ×106/mL during the 18 months. The efficacy between groups A and B was compared for noninferiority.Results:Of the patients, 17/33 (51.5%) receiving continual uFSH/hCG and 19/34 (55.9%) receiving sequential uFSH/hCG achieved sperm concentrations of ≥1.0 × 106/mL. The efficacy in the sequential uFSH/hCG group was not inferior to that in the continual uFSH/hCG group (noninferiority, P= .008) by intention-to-treat analysis.Conclusions:The efficacy of the sequential uFSH/hCG regimen is not inferior to that of the continual uFSH/hCG regimen in inducing spermatogenesis and masculinization of patients with IHH.

Published
2015
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14. Hyperglycemia and duration of diabetes as risk factors for abnormal lipids: a cross sectional survey of 19,757 patients with type 2 diabetes in China

Author

Ji, Linong, Weng, Jianping, Lu, Juming, Guo, Xiaohui, Yang, Wenying, Jia, Weiping, Zou, Dajin, Zhou, Zhiguang, Zhu, Dalong, Ji, Qiuhe, Shi, Lixin, and Yang, Xilin

Abstract

Type 2 diabetes (T2D) increases the risk of cardiovascular disease (CVD). Achieving glycated hemoglobin (HbA1c) below 7.0 % in newly diagnosed T2D reduced CVD risk. It is uncertain whether HbA1c below 7.0 % in T2D with varying duration of diabetes also reduced CVD risk. This study investigated the associations between hyperglycemia and abnormal lipid metabolism in patients with T2D. We conducted a survey of 19,757 outpatients with T2D who were 18 years of age or more and treated with oral antidiabetes drugs (OADs) alone or OADs combined with other drugs. The coverage rates of the 3A hospitals were 74.4 % for Beijing (n= 32), 76 % for Shanghai (n= 22), 55 % for Tianjin (n= 11) and 29.3 % for Guangzhou (n= 12). Abnormal lipids were defined as ≥2.6 mmol/L for low-density lipoprotein (LDL) cholesterol, ≤1.0 mmol/L in men and ≤1.3 mmol/L in women for high-density lipoprotein (HDL) cholesterol; ≥1.7 mmol/L for triglyceride. Logistic regression stratified on city and hospital was used to obtain odds ratio (OR) of hyperglycemia for abnormal lipids. The patients had 4.0 (interquartile range 1.7–8.8) years of duration of diabetes. HbA1c ≥7.0 % was associated with increased risk of high LDL cholesterol (multivariable OR of ≥7.0 vs. <6.0 %:1.37, 95 % confidence interval 1.19–1.57). HbA1c ≥6.5 % was associated increased risk of high triglyceride. HbA1c was associated with low HDL cholesterol in a J-shaped manner, whereby HbA1c levels of <6.0 % as well as ≥6.5 % being associated with increased risk of low HDL cholesterol. Hyperglycemia defined as HbA1c ≥7.0 % increased risk of high LDL cholesterol in T2D.

Published
2014
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15. Role of Fas-Associated Death Domain-containing Protein (FADD) Phosphorylation in Regulating Glucose Homeostasis: from Proteomic Discovery to Physiological Validation*

Author

Yao, Chun, Zhuang, Hongqin, Du, Pan, Cheng, Wei, Yang, Bingya, Guan, Shengwen, Hu, Yun, Zhu, Dalong, Christine, Miller, Shi, Lv, and Hua, Zi-Chun

Abstract

Fas-associated death domain-containing protein (FADD), a classical apoptotic signaling adaptor, participates in different nonapoptotic processes regulated by its phosphorylation. However, the influence of FADD on metabolism, especially glucose homeostasis, has not been evaluated to date. Here, using both two-dimensional electrophoresis and liquid chromatography linked to tandem mass spectrometry (LC/MS/MS), we found that glycogen synthesis, glycolysis, and gluconeogenesis were dysregulated because of FADD phosphorylation, both in MEFs and liver tissue of the mice bearing phosphorylation-mimicking mutation form of FADD (FADD-D). Further physiological studies showed that FADD-D mice exhibited lower blood glucose, enhanced glucose tolerance, and increased liver glycogen content without alterations in insulin sensitivity. Moreover, investigations on the molecular mechanisms revealed that, under basal conditions, FADD-D mice had elevated phosphorylation of Akt with alterations in its downstream signaling, leading to increased glycogen synthesis and decreased gluconeogenesis. Thus, we uncover a novel role of FADD in the regulation of glucose homeostasis by proteomic discovery and physiological validation.

Published
2013
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16. Effect of intensive insulin therapy on β-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial

Author

Weng, Jianping, Li, Yanbing, Xu, Wen, Shi, Lixin, Zhang, Qiao, Zhu, Dalong, Hu, Yun, Zhou, Zhiguang, Yan, Xiang, Tian, Haoming, Ran, Xingwu, Luo, Zuojie, Xian, Jing, Yan, Li, Li, Fangping, Zeng, Longyi, Chen, Yanming, Yang, Liyong, Yan, Sunjie, Liu, Juan, Li, Ming, Fu, Zuzhi, and Cheng, Hua

Published
2008
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17. Incidence of type 1 diabetes in China, 2010-13: population based study

Author

Weng, Jianping, Zhou, Zhiguang, Guo, Lixin, Zhu, Dalong, Ji, Linong, Luo, Xiaoping, Mu, Yiming, and Jia, Weiping

Abstract

ObjectiveTo estimate the incidence of type 1 diabetes in all age groups in China during 2010-13.DesignPopulation based, registry study using data from multiple independent sources.SettingNational registration system in all 505 hospitals providing diabetes care, and communities of patients with diabetes in 13 areas across China, covering more than 133 million person years at risk, approximately 10% of the whole population.Participants5018 people of all ages with newly diagnosed type 1 diabetes and resident in the study areas from 1 January 2010 to 31 December 2013.Main outcome measuresIncidence of type 1 diabetes per 100 000 person years by age, sex, and study area. Type 1 diabetes was doctor diagnosed and further validated by onsite follow-up. Completeness of case ascertainment was assessed using the capture mark recapture method.Results5018 cases of newly diagnosed type 1 diabetes were ascertained: 1239 participants were aged <15 years, 1799 were aged 15-29 years, and 1980 were aged ≥30 years. The proportion of new onset cases in participants aged ≥20 years was 65.3%. The estimated incidence of type 1 diabetes per 100 000 persons years for all ages in China was 1.01 (95% confidence interval 0.18 to 1.84). Incidence per 100 000 persons years by age group was 1.93 (0.83 to 3.03) for 0-14 years, 1.28 (0.45 to 2.11) for 15-29 years, and 0.69 (0.00 to 1.51) for ≥30 years, with a peak in age group 10-14 years. The incidence in under 15s was positively correlated with latitude (r=0.88, P<0.001), although this association was not observed in age groups 15-29 years or ≥30 years.ConclusionMost cases of new onset type 1 diabetes in China occurred among adults. The incidence of type 1 diabetes in Chinese children was among the lowest reported in the study.

Published
2018
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18. Pregnancy outcomes in patients with type 1 diabetes in China: a retrospective study

Author

Zheng, Xueying, Yan, Jinhua, Yang, Daizhi, Luo, Sihui, Zhu, Dalong, Ran, Xingwu, Zhao, Jiajun, Xiao, Xinhua, Guo, Xiaohui, Yang, Tao, Huang, Qin, Zhou, Zhiguang, Liu, Fang, Hu, Ji, Lu, Jing, Ma, Jing, Zhou, Xinli, Ping, Fan, Gu, Nan, Zhang, Mei, Li, Wenwen, Yang, Yaling, Fang, Chen, Yang, Huixia, and Weng, Jianping

Abstract

Sparse data on pregnancy outcomes for women with type 1 diabetes exist in Chinese women. We aimed to investigate maternal, perinatal, and fetal and neonatal outcomes in women with type 1 diabetes in China.

Published
2016
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19. Wharton's jelly-derived mesenchymal stem cell therapy to improve β-cell function in patients with type 1 diabetes and ketoacidosis: a single-centre, single-group, open-label, phase 2 trial

Author

Li, Lirong, Lu, Jing, Shen, Shanmei, Jia, Xiaolei, and Zhu, Dalong

Abstract

Infusion with Wharton's jelly-derived mesenchymal stem cells (WJ-MSCs) might restore the function of islet β cell in patients with type 1 diabetes. However, whether WJ-MSCs can preserve islet β-cell function in patients with type 1 diabetes and a history of diabetic ketoacidosis has not been tested.

Published
2016
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20. Multiple organ-specific autoantibodies in patients with phenotypic type 2 diabetes in China: a post-hoc analysis of the China National Diabetes and Metabolic Disorders Study

Author

Xiang, Yufei, Huang, Gan, Ji, Linong, Jia, Weiping, Weng, Jianping, Lu, Juming, Zhu, Yaxi, Feng, Qiong, Li, Xia, Yang, Tubao, Liu, Zhenqi, Shan, Zhongyan, Liu, Jie, Tian, Haoming, Ji, Qiuhe, Zhu, Dalong, Ge, Jiapu, Lin, Lixiang, Chen, Li, Guo, Xiaohui, Zhao, Zhigang, Li, Qiang, Zuo, Xuan, Liu, Xinyuan, Yang, Wenying, and Zhou, Zhiguang

Abstract

In the China National Diabetes and Metabolic Disorders Study, age-standardised prevalence of total diabetes was 9·7%, accounting for 92·4 million adults, in China in 2010. Using clinical data and serum samples from this study, we aimed to investigate the prevalence of several organ-specific autoantibodies in patients with phenotypic type 2 diabetes.

Published
2016
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