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1. Liraglutide enhances insulin secretion and prolongs the remission period in adults with newly diagnosed type 1 diabetes (the NewLira study): A randomized, double‐blind, placebo‐controlled trial.

Author

Dejgaard, Thomas F., Frandsen, Christian S., Kielgast, Urd, Størling, Joachim, Overgaard, Anne J., Svane, Maria S., Olsen, Markus Harboe, Thorsteinsson, Birger, Andersen, Henrik U., Krarup, Thure, Holst, Jens J., and Madsbad, Sten

Subjects
TYPE 1 diabetes, GLYCEMIC control, INSULIN therapy, LIRAGLUTIDE, HYPOGLYCEMIA
Abstract

Aim: To test the effect of the glucagon‐like peptide‐1 receptor agonist, liraglutide, on residual beta‐cell function in adults with newly diagnosed type 1 diabetes. Materials and Methods: In a multicentre, double‐blind, parallel‐group trial, adults with newly diagnosed type 1 diabetes and stimulated C‐peptide of more than 0.2 nmol/L were randomized (1:1) to 1.8‐mg liraglutide (Victoza) or placebo once daily for 52 weeks with 6 weeks of follow‐up with only insulin treatment. The primary endpoint was the between‐group difference in C‐peptide area under the curve (AUC) following a liquid mixed‐meal test after 52 weeks of treatment. Results: Sixty‐eight individuals were randomized. After 52 weeks, the 4‐hour AUC C‐peptide response was maintained with liraglutide, but decreased with placebo (P =.002). Six weeks after end‐of‐treatment, C‐peptide AUCs were similar for liraglutide and placebo. The average required total daily insulin dose decreased from 0.30 to 0.23 units/kg/day with liraglutide, but increased from 0.29 to 0.43 units/kg/day in the placebo group at week 52 (P <.001). Time without the need for insulin treatment was observed in 13 versus two patients and lasted for 22 weeks (from 3 to 52 weeks) versus 6 weeks (from 4 to 8 weeks) on average for liraglutide and placebo, respectively. Patients treated with liraglutide had fewer episodes of hypoglycaemia compared with placebo‐treated patients. The adverse events with liraglutide were predominantly gastrointestinal and transient. Conclusions: Treatment with liraglutide improves residual beta‐cell function and reduces the dose of insulin during the first year after diagnosis. Beta‐cell function was similar at 6 weeks postliraglutide treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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2. Outcomes with Finerenone in Participants with Stage 4 CKD and Type 2 Diabetes: A FIDELITY Subgroup Analysis

Author

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, Jr, 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 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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, Dino Alferi, 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, Tai Pang Ip, 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, John Baker, 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, Fayzal Ahmed, 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, Bum-Soon Choi, 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, Chiz-Tzung Chang, 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, Ahmad AbouSaleh, 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, Idalia Acosta, 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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4. Effect of Metformin vs. Placebo in Combination with Insulin Analogues on Bone Markers P1NP and CTX in Patients with Type 2 Diabetes Mellitus

Author

Nordklint, Azra Karahasanovic, Almdal, Thomas Peter, Vestergaard, Peter, Lundby-Christensen, Louise, Jørgensen, Niklas Rye, Boesgaard, Trine W., Breum, Leif, Gade-Rasmussen, Birthe, Sneppen, Simone B., Gluud, Christian, Hemmingsen, Bianca, Krarup, Thure, Madsbad, Sten, Mathiesen, Elisabeth R., Perrild, Hans, Tarnow, Lise, Thorsteinsson, Birger, Vestergaard, Henrik, Lund, Søren S., and Eiken, Pia

Published
2020
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6. The Effect of Insulin Degludec Versus Insulin Glargine U100 on Glucose Metrics Recorded During Continuous Glucose Monitoring in People With Type 1 Diabetes and Recurrent Nocturnal Severe Hypoglycemia

Author

Brøsen, Julie Maria Bøggild, primary, Agesen, Rikke Mette, additional, Alibegovic, Amra Ciric, additional, Andersen, Henrik Ullits, additional, Beck-Nielsen, Henning, additional, Gustenhoff, Peter, additional, Hansen, Troels Krarup, additional, Hedetoft, Christoffer, additional, Jensen, Tonny Joran, additional, Juhl, Claus Bogh, additional, Stolberg, Charlotte Røn, additional, Lerche, Susanne Søgaard, additional, Nørgaard, Kirsten, additional, Parving, Hans-Henrik, additional, Tarnow, Lise, additional, Thorsteinsson, Birger, additional, and Pedersen-Bjergaard, Ulrik, additional

Published
2023
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9. Effect of insulin degludec versus insulin glargine U100 on nocturnal glycaemia assessed by plasma glucose profiles in people with type 1 diabetes prone to nocturnal severe hypoglycaemia

Author

Brøsen, Julie Maria Bøggild, Agesen, Rikke Mette, Kristensen, Peter Lommer, Alibegovic, Amra Ciric, Andersen, Henrik Ullits, Beck-Nielsen, Henning, Gustenhoff, Peter, Hansen, Troels Krarup, Hedetoft, Christoffer, Jensen, Tonny, Stolberg, Charlotte Røn, Juhl, Claus Bogh, Lerche, Susanne Søgaard, Nørgaard, Kirsten, Parving, Hans Henrik, Tarnow, Lise, Thorsteinsson, Birger, Pedersen-Bjergaard, Ulrik, Brøsen, Julie Maria Bøggild, Agesen, Rikke Mette, Kristensen, Peter Lommer, Alibegovic, Amra Ciric, Andersen, Henrik Ullits, Beck-Nielsen, Henning, Gustenhoff, Peter, Hansen, Troels Krarup, Hedetoft, Christoffer, Jensen, Tonny, Stolberg, Charlotte Røn, Juhl, Claus Bogh, Lerche, Susanne Søgaard, Nørgaard, Kirsten, Parving, Hans Henrik, Tarnow, Lise, Thorsteinsson, Birger, and Pedersen-Bjergaard, Ulrik

Abstract

Aim To compare nocturnal glucose profiles according to hourly plasma glucose measurements during treatment with insulin degludec and insulin glargine U100 in a cohort of people with type 1 diabetes prone to nocturnal severe hypoglycaemia. Materials and methods The HypoDeg trial is a 2-year investigator-initiated, randomized, controlled crossover trial in 149 participants randomized to treatment with insulin degludec and insulin glargine U100 for 12 months each. The 51 participants in this predefined substudy stayed at least one night in hospital during each treatment arm for plasma glucose samples to be taken. Endpoints were glucose profiles, including mean plasma glucose, glycaemic variability and risk of hypoglycaemia. Results There were no differences between treatments regarding mean plasma glucose. We saw a flatter glucose profile during insulin degludec compared with insulin glargine U100 treatment, which had a nadir at 4:00 AM, with a subsequent rise. During treatment with insulin degludec, the participants had lower glycaemic variability, with an estimated treatment difference of −4.3% (95% confidence interval [CI] −8.1 to −0.5; P < 0.05). Participants treated with insulin degludec were less likely to experience nocturnal hypoglycaemia below 3.0 mmol/L (hazard ratio 0.36 [95% CI 0.17-0.73; P < 0.05]). Conclusion Based on nocturnal plasma glucose measurements, treatment with insulin degludec compared with insulin glargine U100 administered in the evening results in lower glycaemic variability and lower risk of nocturnal hypoglycaemia without differences in mean plasma glucose., Aim: To compare nocturnal glucose profiles according to hourly plasma glucose measurements during treatment with insulin degludec and insulin glargine U100 in a cohort of people with type 1 diabetes prone to nocturnal severe hypoglycaemia. Materials and methods: The HypoDeg trial is a 2-year investigator-initiated, randomized, controlled crossover trial in 149 participants randomized to treatment with insulin degludec and insulin glargine U100 for 12 months each. The 51 participants in this predefined substudy stayed at least one night in hospital during each treatment arm for plasma glucose samples to be taken. Endpoints were glucose profiles, including mean plasma glucose, glycaemic variability and risk of hypoglycaemia. Results: There were no differences between treatments regarding mean plasma glucose. We saw a flatter glucose profile during insulin degludec compared with insulin glargine U100 treatment, which had a nadir at 4:00 AM, with a subsequent rise. During treatment with insulin degludec, the participants had lower glycaemic variability, with an estimated treatment difference of −4.3% (95% confidence interval [CI] −8.1 to −0.5; P < 0.05). Participants treated with insulin degludec were less likely to experience nocturnal hypoglycaemia below 3.0 mmol/L (hazard ratio 0.36 [95% CI 0.17-0.73; P < 0.05]). Conclusion: Based on nocturnal plasma glucose measurements, treatment with insulin degludec compared with insulin glargine U100 administered in the evening results in lower glycaemic variability and lower risk of nocturnal hypoglycaemia without differences in mean plasma glucose.

Published
2023

10. The effect of insulin analogs in people with type 1 diabetes at increased risk of severe hypoglycemia

Author

Broeng-Mikkelgaard, Sofie, Brøsen, Julie Maria Bøggild, Kristensen, Peter Lommer, Thorsteinsson, Birger, Pedersen-Bjergaard, Ulrik, Broeng-Mikkelgaard, Sofie, Brøsen, Julie Maria Bøggild, Kristensen, Peter Lommer, Thorsteinsson, Birger, and Pedersen-Bjergaard, Ulrik

Abstract

Type 1 diabetes is characterized by insulin deficiency, and treatment is to supply insulin mimicking the physiological endogenous insulin secretion. Since its discovery, insulin therapy has evolved, and since the 1990s, an increasing number of insulin analogs with various pharmacokinetic and pharmacodynamic profiles have become available. Despite the improvement of insulin therapy, hypoglycemia remains the main side effect and is a daily concern for many people with diabetes and their families. A proportion of people with type 1 diabetes are at increased risk of hypoglycemia and experience recurring episodes. When designing insulin trials, this group of people is most often excluded in order to reduce the risk of adverse study outcomes, even though it may be the group that may benefit the most from treatment with new insulins. The results of the phase III trials, therefore, underestimate the clinical impact and pharmacoeconomic effect of the implementation of new insulins in the broader type 1 diabetes population. This paper reviews the four insulin trials that include people at increased risk of hypoglycemia. In general, the studies confirm the results from phase III trials in terms of similar reduction and maintenance of HbA1c, as well as relative rate reductions of hypoglycemia. However, the absolute treatment differences in the reduction of hypoglycemia are even greater in the trials, including people at high risk of hypoglycemia. This emphasizes the importance of including people at high risk of hypoglycemia to assess the full clinical and pharmacoeconomic benefit of new insulins.

Published
2023

12. The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design

Author

Agesen, Rikke Mette, Alibegovic, Amra Ciric, Andersen, Henrik Ullits, Beck-Nielsen, Henning, Gustenhoff, Peter, Hansen, Troels Krarup, Hedetoft, Christoffer, Jensen, Tonny, Juhl, Claus Bogh, Lerche, Susanne Søgaard, Nørgaard, Kirsten, Parving, Hans-Henrik, Tarnow, Lise, Thorsteinsson, Birger, and Pedersen-Bjergaard, Ulrik

Published
2019
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13. Effect of insulin degludec versus insulin glargine U100 on nocturnal glycaemia assessed by plasma glucose profiles in people with type 1 diabetes prone to nocturnal severe hypoglycaemia

Author

Brøsen, Julie Maria Bøggild, primary, Agesen, Rikke Mette, additional, Kristensen, Peter Lommer, additional, Alibegovic, Amra Ciric, additional, Andersen, Henrik Ullits, additional, Beck‐Nielsen, Henning, additional, Gustenhoff, Peter, additional, Hansen, Troels Krarup, additional, Hedetoft, Christoffer, additional, Jensen, Tonny, additional, Stolberg, Charlotte Røn, additional, Juhl, Claus Bogh, additional, Lerche, Susanne Søgaard, additional, Nørgaard, Kirsten, additional, Parving, Hans‐Henrik, additional, Tarnow, Lise, additional, Thorsteinsson, Birger, additional, and Pedersen‐Bjergaard, Ulrik, additional

Published
2023
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14. Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea Does Not Reduce Arterial Stiffness in Patients With Type 2 Diabetes After One Year of Follow-Up

Author

Krogager, Christoffer, Banghoj, Anne Margareta, Poulsen, Per L., Kirkegaard, Martin G., Thorsteinsson, Birger, Tarnow, Lise, Laugesen, Esben, and Hansen, Klavs W.

Subjects
Pulse wave velocity, Endocrinology, Diabetes and Metabolism, Diabetes, Arterial stiffness, Obstructive sleep apnea, respiratory tract diseases
Abstract

Background: The aim of this study is to evaluate the effects of 12-month continuous positive airway pressure (CPAP) treatment on arterial stiffness in patients with type 2 diabetes. Methods: Obstructive sleep apnea (OSA) and type 2 diabetes frequently co-exists. Both diseases increase arterial stiffness, a marker of cardiovascular risk. Treating OSA with CPAP may lower arterial stiffness. In a recent randomized trial, we found that CPAP treatment for 12 weeks did not reduce arterial stiffness in type 2 diabetes patients with OSA. Participants from the randomized trial were invited to a follow-up study 12 months after inclusion. We evaluated arterial stiffness by measuring carotid-femoral pulse wave velocity (cfPWV) using SphygmoCor. Results: Forty-six patients (63.9% of the original 72 patients, age 63.8 ± 6.5 years, diabetes duration 16.1 ± 9.7 years, body mass index (BMI) 34.7 ± 3.9 kg/m2) partook in the study. Mean duration of CPAP treatment was 10.5 ± 1.5 months. Baseline cfPWV was 10.7 m/s. At follow-up cfPWV was 10.6 m/s, change in cfPWV:-0.12 m/s, 95% confidence interval (CI):-0.6, 0.4, P = 0.6. Baseline systolic blood pressure (BP) was 136.2 mm Hg. At follow-up BP was 137.9 mm Hg, change in BP: 1.6 mm Hg, 95% CI:-2.3, 5.5. Conclusions: We found no effect of 9-12-month CPAP treatment on arterial stiffness or BP in patients with long duration of type 2 diabetes and OSA.

Published
2021

15. CGM-recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia

Author

Brøsen, Julie Maria Bøggild, Agesen, Rikke Mette, Alibegovic, Amra Ciric, Andersen, Henrik Ullits, Beck-Nielsen, Henning, Gustenhoff, Peter, Hansen, Troels Krarup, Hedetoft, Christoffer Georg Riber, Jensen, Tonny Joran, Stolberg, Charlotte Røn, Juhl, Claus Bogh, Lerche, Susanne Søgaard, Nørgaard, Kirsten, Parving, Hans-Henrik, Tarnow, Lise, Pedersen-Bjergaard, Ulrik, and Thorsteinsson, Birger

Subjects
Type 1 diabetes, endocrine system diseases, Insulin glargine U100, Nocturnal hypoglycemia, nutritional and metabolic diseases, Insulin analogs, Insulin degludec
Abstract

BACKGROUND AND AIMS: Nocturnal hypoglycemia is mainly a consequence of inappropriate basal insulin therapy in type 1 diabetes (T1D) and may compromise optimal glycemic control. Insulin degludec is associated with a lower risk of nocturnal hypoglycemia in T1D. As nocturnal hypoglycemia is often asymptomatic, we applied continuous glucose monitoring (CGM) to detect a more precise occurrence of nocturnal hypoglycemia in the HypoDeg trial, comparing insulin degludec with insulin glargine U100 in people with T1D and previous nocturnal severe hypoglycemia.MATERIALS AND METHODS: In the HypoDeg trial, 149 people with T1D were included in an open-label, randomized, cross-over trial. Sixty-seven participants accepted optional participation in the predefined sub-study of 4x6 days of blinded CGM requiring completion of at least one CGM period in each treatment arm. CGM data were reviewed for hypoglycemic events.RESULTS: Treatment with insulin degludec resulted in a relative rate reduction (RRR) of 36% (95% confidence interval [CI]: 10%-54%; pCONCLUSION: In people with T1D, prone to nocturnal severe hypoglycemia, insulin degludec compared to insulin glargine U100 significantly reduces nocturnal CGM-recorded hypoglycemia.

Published
2022

16. Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial

Author

Pedersen-Bjergaard, Ulrik, Kristensen, Peter Lommer, Beck-Nielsen, Henning, Nørgaard, Kirsten, Perrild, Hans, Christiansen, Jens Sandahl, Jensen, Tonny, Hougaard, Philip, Parving, Hans-Henrik, Thorsteinsson, Birger, and Tarnow, Lise

Published
2014
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17. Impact of Polymorphism in the β2-Receptor Gene on the Metabolic Response to Epinephrine After Repeated Hypoglycemia.

Author

Rokamp, Kim Z., Dela, Flemming, Secher, Niels H., Grønlykke, Lars, Thorsteinsson, Birger, and Pedersen-Bjergaard, Ulrik

Subjects
ADRENALINE, HYPOGLYCEMIA, GENETIC polymorphisms, FREE fatty acids
Abstract

The β2-receptor mediates the metabolic response to epinephrine. This study investigates the impact of the β2-receptor gene (ADRB2) polymorphism Gly16Arg on the metabolic response to epinephrine before and after repetitive hypoglycemia. Twenty-five healthy men selected according to ADRB2 genotype being homozygous for either Gly16 (GG) (n = 12) or Arg16 (AA) (n = 13) participated in 4 trial days (D1–4): D1pre and D4post with epinephrine 0.06 μg kg−1 ⋅ min−1 infusion and D2hypo1–2 and D3hypo3 with three periods of hypoglycemia by an insulin-glucose clamp. At D1pre, the insulin (mean ± SEM of area under the curve 44 ± 8 vs. 93 ± 13 pmol ⋅ L−1 h; P = 0.0051), glycerol (79 ± 12 vs. 115 ± 14 μmol ⋅ L−1 h; P = 0.041), and free fatty acid (724 ± 96 vs. 1,113 ± 140 μmol ⋅ L−1 h; P = 0.033) responses to epinephrine were decreased in AA participants compared with GG participants but without a difference in glucose response. There were no differences in response to epinephrine between genotype groups after repetitive hypoglycemia at D4post. The metabolic substrate response to epinephrine was decreased in AA participants compared with GG participants but without a difference between genotype groups after repetitive hypoglycemia. Article Highlights: This study investigates the impact of the β2-receptor gene (ADRB2) polymorphism Gly16Arg on the metabolic response to epinephrine before and after repetitive hypoglycemia. Healthy men homozygous for either Gly16 (n = 12) or Arg16 (n = 13) participated in the study. Healthy people with the Gly16 genotype have increased metabolic response to epinephrine compared with the Arg16 genotype but without a difference between genotypes after repetitive hypoglycemia. [ABSTRACT FROM AUTHOR]

Published
2023
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18. 218-OR: The Effect of Insulin Degludec vs. Insulin Glargine U100 on Continuous Glucose Monitoring (CGM) Recorded Glycemic Metrics in People with Type 1 Diabetes and Recurrent Nocturnal Severe Hypoglycemia

Author

BRØSEN, JULIE M., primary, AGESEN, RIKKE, additional, ALIBEGOVIC, AMRA CIRIC, additional, ANDERSEN, HENRIK U., additional, GUSTENHOFF, PETER, additional, HANSEN, TROELS K., additional, HEDETOFT, CHRISTOFFER, additional, STOLBERG, CHARLOTTE R., additional, JUHL, CLAUS B., additional, LERCHE, SUSANNE, additional, NØRGAARD, KIRSTEN, additional, TARNOW, LISE, additional, THORSTEINSSON, BIRGER, additional, and PEDERSEN-BJERGAARD, ULRIK, additional

Published
2022
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19. The Effect of Insulin Degludec vs. Insulin Glargine U100 on Continuous Glucose Monitoring (CGM) Recorded Glycemic Metrics in People with Type 1 Diabetes and Recurrent Nocturnal Severe Hypoglycemia

Author

Brøsen, Julie M., Agesen, Rikke, Alibegovic, Amra Ciric, Andersen, Henrik U., Gustenhoff, Peter, Hansen, Troels K., Hedetoft, Christoffer, Stolberg, Charlotte R., Juhl, Claus B., Lerche, Susanne, Nørgaard, Kirsten, Tarnow, Lise, Thorsteinsson, Birger, Pedersen-bjergaard, Ulrik, Brøsen, Julie M., Agesen, Rikke, Alibegovic, Amra Ciric, Andersen, Henrik U., Gustenhoff, Peter, Hansen, Troels K., Hedetoft, Christoffer, Stolberg, Charlotte R., Juhl, Claus B., Lerche, Susanne, Nørgaard, Kirsten, Tarnow, Lise, Thorsteinsson, Birger, and Pedersen-bjergaard, Ulrik

Published
2022

20. The updated Pedersen-Bjergaard method for assessment of awareness of hypoglycaemia in type 1 diabetes

Author

Pedersen-Bjergaard, Ulrik, Færch, Louise, Thorsteinsson, Birger, Pedersen-Bjergaard, Ulrik, Færch, Louise, and Thorsteinsson, Birger

Abstract

INTRODUCTION. Loss of awareness of hypoglycaemia is the major risk factor for severe hypoglycaemia in type 1 diabetes. Three methods for assessment of self-reported awareness have been validated and used more widely: the Gold, the Clarke and the Pedersen-Bjergaard classification. Comparisons between the methods are hampered by the latter operating with three classes, whereas the other methods are bimodal. We have therefore updated the Pedersen-Bjergaard classification and here present a comparison of the three methods. METHODS. Adult people with type 1 diabetes (n = 325) completed a validated questionnaire. Hypoglycaemia awareness was self-reported by the three methods: Gold, Clarke and Pedersen-Bjergaard scores. The latter was updated by renaming the previous "impaired " class to "intermediate ". RESULTS. A total of 24%, 17% and 14% of patients were classified as having loss of awareness by the Gold, Clarke and updated Pedersen-Bjergaard methods, respectively, with reasonably good agreement and all with increased rates of severe hypoglycaemia. The latter classified 43% with normal and 43% with intermediate awareness and low and average rate of severe hypoglycaemia, respectively. CONCLUSION. The three classifications identified people with loss of awareness with a reasonably high degree of concordance. In contrast to the others, the updated Pedersen-Bjergaard method identified groups with normal and intermediate awareness with clinically significant different risks of severe hypoglycaemia.

Published
2022

21. Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia

Author

Brøsen, Julie Maria Bøggild, Agesen, Rikke Mette, Alibegovic, Amra Ciric, Ullits Andersen, Henrik, Beck-Nielsen, Henning, Gustenhoff, Peter, Krarup Hansen, Troels, Hedetoft, Christoffer Georg Riber, Jensen, Tonny Joran, Stolberg, Charlotte Røn, Bogh Juhl, Claus, Lerche, Susanne Søgaard, Nørgaard, Kirsten, Parving, Hans Henrik, Tarnow, Lise, Thorsteinsson, Birger, Pedersen-Bjergaard, Ulrik, Brøsen, Julie Maria Bøggild, Agesen, Rikke Mette, Alibegovic, Amra Ciric, Ullits Andersen, Henrik, Beck-Nielsen, Henning, Gustenhoff, Peter, Krarup Hansen, Troels, Hedetoft, Christoffer Georg Riber, Jensen, Tonny Joran, Stolberg, Charlotte Røn, Bogh Juhl, Claus, Lerche, Susanne Søgaard, Nørgaard, Kirsten, Parving, Hans Henrik, Tarnow, Lise, Thorsteinsson, Birger, and Pedersen-Bjergaard, Ulrik

Abstract

Background and Aims: Nocturnal hypoglycemia is mainly a consequence of inappropriate basal insulin therapy in type 1 diabetes (T1D) and may compromise optimal glycemic control. Insulin degludec is associated with a lower risk of nocturnal hypoglycemia in T1D. As nocturnal hypoglycemia is often asymptomatic, we applied continuous glucose monitoring (CGM) to detect a more precise occurrence of nocturnal hypoglycemia in the HypoDeg trial, comparing insulin degludec with insulin glargine U100 in people with T1D and previous nocturnal severe hypoglycemia. Materials and Methods: In the HypoDeg trial, 149 people with T1D were included in an open-label randomized cross-over trial. Sixty-seven participants accepted optional participation in the predefined substudy of 4 × 6 days of blinded CGM requiring completion of at least one CGM period in each treatment arm. CGM data were reviewed for hypoglycemic events. Results: Treatment with insulin degludec resulted in a relative rate reduction (RRR) of 36% (95% confidence interval [CI]: 10%-54%; P < 0.05) in nocturnal CGM-recorded hypoglycemia (≤3.9 mmol/L), corresponding to an absolute rate reduction (ARR) of 0.85 events per person-week. In nocturnal CGM-recorded hypoglycemia (≤3.0 mmol/L), we found an RRR of 53% (95% CI: 36%-65%; P < 0.001), corresponding to an ARR of 0.75 events per person-week. At the lower detection limit of the CGM (≤2.2 mmol/L), treatment with insulin degludec resulted in a significant RRR of 58% (95% CI: 23%-77%; P = 0.005). The reductions were primarily due to significant RRRs in asymptomatic hypoglycemia. Conclusion: In people with T1D, prone to nocturnal severe hypoglycemia, insulin degludec compared with insulin glargine U100 significantly reduces nocturnal CGM-recorded hypoglycemia. www.clinicaltrials.gov (#NCT02192450).

Published
2022

22. Continuous Glucose Monitoring (CGM) Readings During Patient-Reported Symptomatic Hypoglycemia:Assessment of the Advanced Technologies and Treatments for Diabetes Consensus Definition of CGM-Recorded Hypoglycemia

Author

Hornborg Svensson, Cecilie, Henriksen, Marie Moth, Thorsteinsson, Birger, Pedersen-Bjergaard, Ulrik, Hornborg Svensson, Cecilie, Henriksen, Marie Moth, Thorsteinsson, Birger, and Pedersen-Bjergaard, Ulrik

Abstract

Aim: Continuous glucose monitoring (CGM) is widely used in clinical practice and research to detect hypoglycemia. A consensus definition of CGM-recorded hypoglycemia is made by a group of international experts under the auspice of the Advanced Technologies and Treatments for Diabetes (ATTD). The purpose of this study is to compare the definition with patient-reported hypoglycemia. Methods: In a prospective, observational study of 186 patients with type 1 diabetes using blinded Medtronic iPro 2 CGM for 6 days, every patient-reported symptomatic hypoglycemic event and interstitial glucose (IG) values at the registration time were classified according to the ATTD definition of CGM-recorded hypoglycemia. For comparison between CGM and self-monitored blood glucose (SMBG) values, the International Hypoglycemia Study Group (IHSG) classification of hypoglycemia and chi-square test were used. Results: A total of 321 events of symptomatic hypoglycemia were reported by 68% of the patients, corresponding to 2.0 ± 2.3 events (mean ± standard deviation) per patient-week. A total of 206 (64%) events met the CGM consensus definition. In the remaining 115 (36%) not-confirmed events, 5 events had an IG <3.9 mmol/L, which lasted <15 min. The overall mean IG value was 3.6 ± 1.1 mmol/L (median 3.1, range 2.2-10.4). In symptomatic hypoglycemic events with both CGM and SMBG data, SMBG confirmed significantly more symptomatic hypoglycemic events than CGM (P < 0.001). Conclusion: CGM-recorded hypoglycemia according to the consensus definition is present at two thirds of all patient-reported events when recorded by the Medtronic iPro 2 system. The recommended minimum duration of a hypoglycemic event of 15 min is supported by the study. SMBG measurements detect significantly more symptomatic hypoglycemic events than Medtronic iPro 2 CGM.

Published
2022

23. Effects of 18-months metformin versus placebo in combination with three insulin regimens on RNA and DNA oxidation in individuals with type 2 diabetes:A post-hoc analysis of a randomized clinical trial

Author

Larsen, Emil List, Kjær, Laura K., Lundby-Christensen, Louise, Boesgaard, Trine W., Breum, Leif, Gluud, Christian, Hedetoft, Christoffer, Krarup, Thure, Lund, Søren S., Mathiesen, Elisabeth R., Perrild, Hans, Sneppen, Simone B., Tarnow, Lise, Thorsteinsson, Birger, Vestergaard, Henrik, Poulsen, Henrik E., Madsbad, Sten, Almdal, Thomas P., Larsen, Emil List, Kjær, Laura K., Lundby-Christensen, Louise, Boesgaard, Trine W., Breum, Leif, Gluud, Christian, Hedetoft, Christoffer, Krarup, Thure, Lund, Søren S., Mathiesen, Elisabeth R., Perrild, Hans, Sneppen, Simone B., Tarnow, Lise, Thorsteinsson, Birger, Vestergaard, Henrik, Poulsen, Henrik E., Madsbad, Sten, and Almdal, Thomas P.

Abstract

Formation of reactive oxygen species has been linked to the development of diabetes complications. Treatment with metformin has been associated with a lower risk of developing diabetes complications, including when used in combination with insulin. Metformin inhibits Complex 1 in isolated mitochondria and thereby decreases the formation of reactive oxygen species. Thus, we post-hoc investigated the effect of metformin in combination with different insulin regimens on RNA and DNA oxidation in individuals with type 2 diabetes. Four hundred and fifteen individuals with type 2 diabetes were randomized (1:1) to blinded treatment with metformin (1,000 mg twice daily) versus placebo and to (1:1:1) open-label biphasic insulin, basal-bolus insulin, or basal insulin therapy in a 2 × 3 factorial design. RNA and DNA oxidation were determined at baseline and after 18 months measured as urinary excretions of 8-oxo-7,8-dihydroguanosine (8-oxoGuo) and 8-oxo-7,8-dihydro-2′-deoxyguanosine (8-oxodG), respectively. Urinary excretion of 8-oxoGuo changed by +7.1% (95% CI: 0.5% to 14.0%, P = 0.03) following metformin versus placebo, whereas changes in 8-oxodG were comparable between intervention groups. Biphasic insulin decreased urinary excretion of 8-oxoGuo (within-group: −9.6% (95% CI: −14.4% to −4.4%)) more than basal-bolus insulin (within-group: 5.2% (95% CI: −0.5% to 11.2%)), P = 0.0002 between groups, and basal insulin (within-group: 3.7% (95% CI: −2.0% to 9.7%)), P = 0.0007 between groups. Urinary excretion of 8-oxodG decreased more in the biphasic insulin group (within-group: −9.9% (95% CI: −14.4% to −5.2%)) than basal-bolus insulin (within group effect: −1.2% (95% CI: −6.1% to 3.9%)), P = 0.01 between groups, whereas no difference was observed compared with basal insulin. In conclusion, eighteen months of metformin treatment in addition to different insulin regimens increased RNA oxidation, but not DNA oxidation. Biphasic insulin decreased both RNA and DNA oxidation compared

Published
2022

24. Comparison of treatment with insulin degludec and glargine U100 in patients with type 1 diabetes prone to nocturnal severe hypoglycaemia:The HypoDeg randomized, controlled, open-label, crossover trial

Author

Pedersen-Bjergaard, Ulrik, Agesen, Rikke M., Brosen, Julie M. B., Alibegovic, Amra C., Andersen, Henrik U., Beck-Nielsen, Henning, Gustenhoff, Peter, Hansen, Troels K., Hedetoft, Christoffer, Jensen, Tonny J., Juhl, Claus B., Jensen, Andreas K., Lerche, Susanne S., Norgaard, Kirsten, Parving, Hans-Henrik, Sørensen, Anne L., Tarnow, Lise, Thorsteinsson, Birger, Pedersen-Bjergaard, Ulrik, Agesen, Rikke M., Brosen, Julie M. B., Alibegovic, Amra C., Andersen, Henrik U., Beck-Nielsen, Henning, Gustenhoff, Peter, Hansen, Troels K., Hedetoft, Christoffer, Jensen, Tonny J., Juhl, Claus B., Jensen, Andreas K., Lerche, Susanne S., Norgaard, Kirsten, Parving, Hans-Henrik, Sørensen, Anne L., Tarnow, Lise, and Thorsteinsson, Birger

Published
2022

27. CGM-recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia

Author

Brøsen, Julie Maria Bøggild, primary, Agesen, Rikke Mette, additional, Alibegovic, Amra Ciric, additional, Andersen, Henrik Ullits, additional, Beck-Nielsen, Henning, additional, Gustenhoff, Peter, additional, Hansen, Troels Krarup, additional, Hedetoft, Christoffer Georg Riber, additional, Jensen, Tonny Joran, additional, Stolberg, Charlotte Røn, additional, Juhl, Claus Bogh, additional, Lerche, Susanne Søgaard, additional, Nørgaard, Kirsten, additional, Parving, Hans-Henrik, additional, Tarnow, Lise, additional, Pedersen-Bjergaard, Ulrik, additional, and Thorsteinsson, Birger, additional

Published
2022
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29. Effects of 18-months metformin versus placebo in combination with three insulin regimens on RNA and DNA oxidation in individuals with type 2 diabetes: A post-hoc analysis of a randomized clinical trial

Author

Larsen, Emil List, primary, Kjær, Laura K., additional, Lundby-Christensen, Louise, additional, Boesgaard, Trine W., additional, Breum, Leif, additional, Gluud, Christian, additional, Hedetoft, Christoffer, additional, Krarup, Thure, additional, Lund, Søren S., additional, Mathiesen, Elisabeth R., additional, Perrild, Hans, additional, Sneppen, Simone B., additional, Tarnow, Lise, additional, Thorsteinsson, Birger, additional, Vestergaard, Henrik, additional, Poulsen, Henrik E., additional, Madsbad, Sten, additional, and Almdal, Thomas P., additional

Published
2022
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32. Comparison of treatment with insulin degludec and glargine U100 in patients with type 1 diabetes prone to nocturnal severe hypoglycaemia: The HypoDeg randomized, controlled, open‐label, crossover trial

Author

Pedersen‐Bjergaard, Ulrik, primary, Agesen, Rikke M., additional, Brøsen, Julie M. B., additional, Alibegovic, Amra C., additional, Andersen, Henrik U., additional, Beck‐Nielsen, Henning, additional, Gustenhoff, Peter, additional, Hansen, Troels K., additional, Hedetoft, Christoffer, additional, Jensen, Tonny J., additional, Juhl, Claus B., additional, Jensen, Andreas K., additional, Lerche, Susanne S., additional, Nørgaard, Kirsten, additional, Parving, Hans‐Henrik, additional, Sørensen, Anne L., additional, Tarnow, Lise, additional, and Thorsteinsson, Birger, additional

Published
2021
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39. 131-OR: ADA Presidents’ Select Abstract: Effect of Insulin Degludec vs. Insulin Glargine U100 on Occurrence of Nocturnal Hypoglycemia Assessed by Nocturnal Plasma Glucose Profiles in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia

Author

BRØSEN, JULIE M., primary, AGESEN, RIKKE, additional, KRISTENSEN, PETER L., additional, ALIBEGOVIC, SR., AMRA CIRIC, additional, ANDERSEN, HENRIK U., additional, GUSTENHOFF, PETER, additional, HEDETOFT, CHRISTOFFER, additional, JENSEN, TONNY, additional, JUHL, SR., CLAUS B., additional, LERCHE, SUSANNE, additional, NØRGAARD, KIRSTEN, additional, PARVING, HANS-HENRIK D., additional, TARNOW, LISE, additional, THORSTEINSSON, BIRGER, additional, and PEDERSEN-BJERGAARD, ULRIK, additional

Published
2021
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40. Synthetic long-acting insulin analogs for the management of type 1 diabetes:an update

Author

Pedersen-Bjergaard, Ulrik, Fabricius, Therese W., Thorsteinsson, Birger, Pedersen-Bjergaard, Ulrik, Fabricius, Therese W., and Thorsteinsson, Birger

Abstract

Introduction: Type 1 diabetes is characterized by insulin deficiency and requires near-physiological insulin replacement. In most patients, this is accomplished by basal bolus therapy consisting of a long-acting basal insulin administered once or twice daily and short-acting insulin with main meals. Several long-acting insulin analogs have been developed to optimize basal insulin therapy. Areas covered: This paper reviews the design of–and data from–randomized controlled trials (RCTs) to assess glucose lowering efficacy and safety of long-acting insulin analogs for the treatment of type 1 diabetes. Expert opinion: Due to the non-inferiority treat-to-target design of insulin, RCTs treatment differences primarily appear as differences in hypoglycemia risk. Data suggest that the first generation long-acting insulin analogs insulin glargine U100 and insulin detemir have a similar glucose lowering efficacy compared to NPH insulin but a lower risk of hypoglycemia, particularly during nighttime. The newer analogs insulin glargine U300 and insulin degludec provide non-inferior efficacy, although insulin glargine U300 is less potent unit-to-unit. Insulin degludec reduces hypoglycemia risk compared to insulin glargine U100. Future studies should explore the potential for further improvement of treatment results in type 1 diabetes by a structured approach to personalization of basal insulin therapy.

Published
2021

41. Gustatory sweating in people with type 1 and type 2 diabetes mellitus:Prevalence and risk factors

Author

Klarskov, Carina Kirstine, von Rohden, Elena, Thorsteinsson, Birger, Tarnow, Lise, Lommer Kristensen, Peter, Klarskov, Carina Kirstine, von Rohden, Elena, Thorsteinsson, Birger, Tarnow, Lise, and Lommer Kristensen, Peter

Abstract

Objective: Gustatory sweating (GS) is characterized by profuse sweating during or immediately after ingestion of food and is known as a complication of diabetes mellitus (DM). This study aimed to determine the prevalence of GS and to characterize the sweating in a cohort of patients with type 1 and type 2 diabetes mellitus (T1DM and T2DM) as compared with a control group. Methods: In a cross-sectional study, 665 outpatients with T1DM and 505 outpatients with T2DM filled in an 8-point questionnaire about GS. Answers were paired with medical data from the electronic patient records to explore associations with DM complications. The control group consisted of 1158 persons without DM answering the same questionnaire in an online version. Results: In people with T1DM and T2DM, the prevalence of GS was 10% (95% CI 7%–12%) and 13% (95% CI 10%–16%), respectively. In the control group, the prevalence of GS was 5% (95% CI 3%–6%). Most commonly, people sweat on the face and/or head and upper body with a duration of 10–30 min albeit in the control group <10 min. In patients with T1DM, increased HbA1c was associated with GS (OR 1.3 [95% CI 1.05–1.6], p =.016), and in T2DM, younger age (OR 0.95 [95% CI 0.92–0.99), p =.006), presence of severe peripheral neuropathy (OR 2.33 [95% CI 1.04–5.2], p =.039) and absence of proliferative retinopathy were associated with GS (OR 0.22 [95% CI 0.07–0.71], p =.011). Conclusion: We found the prevalence of gustatory sweating of 11% in a hospital-based cohort of patients with T1DM and T2DM. This was twice as high as in non-diabetic control persons. Associations between GS and known diabetes complications could only be demonstrated in T2DM. Compared with a control group without DM, odds for GS are higher in people with DM and age >45.

Published
2021

43. Effect of 12-week continuous positive airway pressure therapy on glucose levels assessed by continuous glucose monitoring in people with type 2 diabetes and obstructive sleep apnoea; a randomized controlled trial

Author

Banghøj, Anne Margareta, Krogager, Christoffer, Kristensen, Peter Lommer, Hansen, Klavs Würgler, Laugesen, Esben, Fleischer, Jesper, Lebech Cichosz, Simon, Poulsen, Per Løgstrup, Glymer Kirkegaard, Martin, Thorsteinsson, Birger, Tarnow, Lise, Banghøj, Anne Margareta, Krogager, Christoffer, Kristensen, Peter Lommer, Hansen, Klavs Würgler, Laugesen, Esben, Fleischer, Jesper, Lebech Cichosz, Simon, Poulsen, Per Løgstrup, Glymer Kirkegaard, Martin, Thorsteinsson, Birger, and Tarnow, Lise

Abstract

Aim: Obstructive sleep apnoea (OSA) is frequent in type 2 diabetes (T2D). The aim was to investigate the effect of a 12-week treatment with continuous positive airway pressure (CPAP) on glycaemic control assessed by continuous glucose monitoring (CGM), HbA1c and fasting blood glucose in patients with T2D and newly detected OSA. Methods: In a randomized controlled multicentre study, 72 participants with T2D and moderate to severe OSA (78% male, age 62 ± 7, AHI 35 ± 15) were recruited from outpatient clinics in three Danish hospitals and were randomized to CPAP intervention or control. The main outcome was glycaemic control assessed by 6 days CGM at baseline and after 12-week therapy, as well as by HbA1c and fasting blood glucose. Results: No significant changes were found in average glucose levels, time in glucose range, time with hypoglycaemia, time with hyperglycaemia or coefficient of variability. HbA1c decreased 0.7 mmol/mol (0.07%; P =.8) in the CPAP group and increased 0.8 mmol/mol (0.08%; P =.6) in the control group (intergroup difference, P =.6). Fasting blood glucose increased by 0.2 mmol/L (P =.02) in the CPAP group and by 0.4 mmol/L (P =.01) in the control group (intergroup difference, P =.7). In a prespecified subgroup analysis comparing participants with high adherence (minimum usage of four hours/night for 70% of all nights) to CPAP to the control group, no significant changes were observed either, although these participants had a tendency towards better glycaemic indices. Conclusions: CPAP treatment for 12 weeks does not significantly change glycaemic control in patients with type 2 diabetes and OSA.

Published
2021

45. Comparison of Treatment with Insulin Degludec and Glargine U100 in Patients with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycaemia (HypoDeg):A Prospective, Randomized, Open-Label, Crossover Trial

Author

Agesen, Rikke, Alibegovic, Amra Ciric, Andersen, Henrik Ullits, Beck-Nielsen, Henning, Gustenhoff, Peter, Hansen, Troels Krarup, Hedetoft, Christoffer, Jensen, Tonny, Juhl, Claus Bogh, Jensen, Andreas Kryger, Lerche, Susanne Søgaard, Nørgaard, Kirsten, Parving, Hans-Henrik, Sørensen, Anne Lyngholm, Tarnow, Lise, Thorsteinsson, Birger, Pedersen-Bjergaard, Ulrik, Agesen, Rikke, Alibegovic, Amra Ciric, Andersen, Henrik Ullits, Beck-Nielsen, Henning, Gustenhoff, Peter, Hansen, Troels Krarup, Hedetoft, Christoffer, Jensen, Tonny, Juhl, Claus Bogh, Jensen, Andreas Kryger, Lerche, Susanne Søgaard, Nørgaard, Kirsten, Parving, Hans-Henrik, Sørensen, Anne Lyngholm, Tarnow, Lise, Thorsteinsson, Birger, and Pedersen-Bjergaard, Ulrik

Abstract

Background: Hypoglycaemia, especially nocturnal, remains a main limiting factor of achieving good glycemic control in type 1 diabetes. The long-acting insulin analog degludec reduces the risk of nocturnal hypoglycemia in patients with type 1 diabetes but is not studied in patients specifically prone to severe nocturnal hypoglycemia. The study aims to investigate whether insulin degludec in comparison with insulin glargine U100 reduces the risk of nocturnal hypoglycaemia in patients with previous severe nocturnal hypoglycaemia. Methods: Investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE), multicenter, cross-over study. A one-year plus one-year treatment period was specified. Each one-year treatment period consisted of a three-month run-in/cross-over period followed by a nine-month maintenance period. A total of 149 adult patients with type 1 diabetes and at least one episode of nocturnal severe hypoglycemia during the preceding two years were included. Participants were randomized 1:1 to basal- bolus therapy with insulin degludec and insulin aspart or insulin glargine U100 and insulin aspart. The primary endpoint was number of nocturnal symptomatic hypoglycemic episodes during the maintenance period, analysed by intention-to-treat. Findings: Treatment with insulin degludec resulted in a 28% (95%CI: 9-43; p=0·02) and 37% (95%CI: 16-53; p=0·002) relative rate reduction (RRR) of level 1 (≤3·9 mmol/L) and level 2 (≤3·0 mmol/L) nocturnal (00:00 to 05:59) symptomatic hypoglycaemia, respectively, compared to insulin glargine U100. Similar results were demonstrated when defining night-time from 23:00 to 06:59 with a 28% (95%CI: 4-45; p=0·01) and 34% (95%CI:17-48; p<0·001) RRR for level 1 and 2 hypoglycaemia, respectively. Interpretation: Patients with type 1 diabetes prone to nocturnal severe hypoglycaemia have lower rates of nocturnal symptomatic hypoglycaemia with insulin degludec as compared with insulin glargine U100.

Published
2020

46. Effect of 12 weeks continuous positive airway pressure on day and night arterial stiffness and blood pressure in patients with type 2 diabetes and obstructive sleep apnea:A randomized controlled trial

Author

Krogager, Christoffer, Banghøj, Anne Margareta, Poulsen, Per L., Kirkegaard, Martin G., Thorsteinsson, Birger, Tarnow, Lise, Hansen, Klavs W., Laugesen, Esben, Krogager, Christoffer, Banghøj, Anne Margareta, Poulsen, Per L., Kirkegaard, Martin G., Thorsteinsson, Birger, Tarnow, Lise, Hansen, Klavs W., and Laugesen, Esben

Abstract

The objective of this study was to evaluate the effect of continuous positive airway pressure treatment on pulse wave velocity and blood pressure in patients with type 2 diabetes and obstructive sleep apnea. A randomized controlled study was performed, including 72 patients with type 2 diabetes and newly diagnosed obstructive sleep apnea recruited from outpatient clinics at three Danish hospitals. The patients were randomized to continuous positive airway pressure for 12 weeks or no continuous positive airway pressure. Office measurements were performed at baseline, 4 weeks and 12 weeks. At baseline and 12 weeks, a 24-hr measurement of pulse wave velocity and blood pressure was performed. No significant change was observed in the primary outcome variable of carotid-femoral pulse wave velocity measured with SphygmoCor. With the Mobil-O-Graph, changes in office pulse wave velocity between the groups were significant: 0.3 m/s; 95% confidence interval, 0.1–0.6; p =.02. The group receiving continuous positive airway pressure had a larger decrease in pulse wave velocity than controls but none of the changes within the groups were significant. No significant change in ambulatory blood pressure was observed in any of the two groups after 12 weeks. In conclusion, continuous positive airway pressure treatment for 12 weeks does not significantly reduce pulse wave velocity or blood pressure in patients with type 2 diabetes and obstructive sleep apnea.

Published
2020

47. Metformin may adversely affect orthostatic blood pressure recovery in patients with type 2 diabetes:Substudy from the placebo-controlled Copenhagen Insulin and Metformin Therapy (CIMT) trial

Author

Hansen, Christian Stevns, Lundby-Christiansen, Louise, Tarnow, Lise, Gluud, Christian, Hedetoft, Christoffer, Thorsteinsson, Birger, Hemmingsen, Bianca, Wiinberg, Niels, Sneppen, Simone B., Lund, Søren S., Krarup, Thure, Madsbad, Sten, Almdal, Thomas, Carstensen, Bendix, Jørgensen, Marit E., Hansen, Christian Stevns, Lundby-Christiansen, Louise, Tarnow, Lise, Gluud, Christian, Hedetoft, Christoffer, Thorsteinsson, Birger, Hemmingsen, Bianca, Wiinberg, Niels, Sneppen, Simone B., Lund, Søren S., Krarup, Thure, Madsbad, Sten, Almdal, Thomas, Carstensen, Bendix, and Jørgensen, Marit E.

Abstract

Background: Metformin has been shown to have both neuroprotective and neurodegenerative effects. The aim of this study was to investigate the effect of metformin in combination with insulin on cardiovascular autonomic neuropathy (CAN) and distal peripheral neuropathy (DPN) in individuals with type 2 diabetes (T2DM). Methods: The study is a sub-study of the CIMT trial, a randomized placebo-controlled trial with a 2 × 3 factorial design, where 412 patients with T2DM were randomized to 18 months of metformin or placebo in addition to open-labelled insulin. Outcomes were measures of CAN: Changes in heart rate response to deep breathing (beat-to-beat), orthostatic blood pressure (OBP) and heart rate and vibration detection threshold (VDT) as a marker DPN. Serum levels of vitamin B12 and methyl malonic acid (MMA) were analysed. Results: After 18 months early drop in OBP (30 s after standing) was increased in the metformin group compared to placebo: Systolic blood pressure drop increased by 3.4 mmHg (95% CI 0.6; 6.2, p = 0.02) and diastolic blood pressure drop increased by 1.3 mmHg (95% CI 0.3; 2.6, p = 0.045) compared to placebo. Beat-to-beat variation decreased in the metformin group by 1.1 beats per minute (95% CI-2.4; 0.2, p = 0.10). Metformin treatment did not affect VDT group difference-0.33 V (95% CI-1.99; 1.33, p = 0.39) or other outcomes. Changes in B12, MMA and HbA1c did not confound the associations. Conclusions: Eighteen months of metformin treatment in combination with insulin compared with insulin alone increased early drop in OBP indicating an adverse effect of metformin on CAN independent of vitamin B12, MMA HbA1c. Trial registration The protocol was approved by the Regional Committee on Biomedical Research Ethics (H-D-2007-112), the Danish Medicines Agency and registered with ClinicalTrials.gov (NCT00657943).

Published
2020

48. Prediction of carotid intima-media thickness and its relation to cardiovascular events in persons with type 2 diabetes

Author

Winckler, Karoline, Thorsteinsson, Birger, Wiinberg, Niels, Jensen, Andreas Kryger, Lundby-Christensen, Louise, Heitmann, Berit Lilienthal, Lund, Søren S., Krarup, Thure, Jensen, Tonny, Vestergaard, Henrik, Breum, Leif, Sneppen, Simone, Boesgaard, Trine, Madsbad, Sten, Gluud, Christian, Vaag, Allan, Almdal, Thomas P., Tarnow, Lise, Winckler, Karoline, Thorsteinsson, Birger, Wiinberg, Niels, Jensen, Andreas Kryger, Lundby-Christensen, Louise, Heitmann, Berit Lilienthal, Lund, Søren S., Krarup, Thure, Jensen, Tonny, Vestergaard, Henrik, Breum, Leif, Sneppen, Simone, Boesgaard, Trine, Madsbad, Sten, Gluud, Christian, Vaag, Allan, Almdal, Thomas P., and Tarnow, Lise

Abstract

Aims: To investigate measures of carotid intima-media thickness (IMT) and conventional cardiovascular (CV) risk factors as predictors of future carotid IMT, and the prediction of CV events during follow-up based on measures of carotid IMT. Methods: Observational longitudinal study including 230 persons with type 2 diabetes (T2D). Results: Mean age at follow-up was 66.7 (SD 8.5) years, 30.5% were women and mean body mass index (BMI) was 31.8 (4.4) kg/m2. Carotid IMT was measured at baseline, after 18 months of intervention in the Copenhagen Insulin and Metformin Therapy (CIMT) trial and after a mean follow-up of 6.4 (1.0) years. Baseline carotid IMT, carotid IMT after 18 months' intervention, and CV risk factors (age, sex and baseline systolic blood pressure) gave the best prediction of carotid IMT (root mean-squared error of prediction of 0.106 and 95% prediction error probability interval of −0.160, 0.204). Conclusions: Measures of carotid IMT combined with CV risk factors at baseline predicts attained carotid IMT better than measures of carotid IMT or CV risk factors alone. Carotid IMT did not predict CV events, and the present results do not support the use of carotid IMT as a predictor of CV events in persons with T2D.

Published
2020

49. Progression in risk factors during 36 years of follow-up and prediction of carotid intima-media thickness in a large cohort of adults with and without diabetes

Author

Winckler, Karoline, Wiinberg, Niels, Jensen, Andreas Kryger, Thorsteinsson, Birger, Lundby-Christensen, Louise, Heitmann, Berit Lilienthal, Jensen, Gorm Boje, Tarnow, Lise, Winckler, Karoline, Wiinberg, Niels, Jensen, Andreas Kryger, Thorsteinsson, Birger, Lundby-Christensen, Louise, Heitmann, Berit Lilienthal, Jensen, Gorm Boje, and Tarnow, Lise

Abstract

Carotid intima-media thickness (IMT) can assess the cumulative effect of atherosclerotic risk factors and provides an independent predictor of future cardiovascular (CV) risk. The aim of this study was to investigate the progression of conventional risk factors in 933 long-term survivors from a Danish cohort with and without diabetes mellitus (DM) as predictors for attained carotid IMT during 35.6 (0.7) years of follow-up. Persons who participated in the first, the last and one of the intermediate rounds of the Copenhagen City Heart Study, and who had had an ultrasound-derived measure of the carotid IMT performed at the last examination were included in the analyses. The risk factors varied between persons with and without DM during the 36 years, but the difference in blood pressure disappeared in the fifth examination, where, in addition, total cholesterol was found to be lower in persons with DM. In this cohort there were no difference in attained carotid IMT between persons with and without DM at the last examination. The following risk factors were found to best predict carotid IMT: age, maximum systolic BP, average systolic BP, average BMI, minimum BMI, sex and years of smoking. The prediction of carotid IMT was clinically poor with a root mean-squared error of prediction (RMSEP) of 0.134 mm and a 95% prediction error probability interval of (−0.22; 0.30). Furthermore, the distribution of prediction errors was skewed to the right indicating that the prediction errors were larger among persons with high carotid IMT.

Published
2020

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