Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes.
| Title: | Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. |
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| Authors: | Gough S.C.; Bode B.; Woo V.; Rodbard H.W.; Linjawi S.; Poulsen P.; Damgaard L.H.; Buse J.B.; NN9068 3697 trial investigators; Donnelly T; Gerstman M; Linjawi S; Park K; Roberts A; Shaw JE; Wu T; Aggarwal N; Bowering K; Chouinard G; DeYoung P; Dumas R; Elliott TG; Frechette A; Giguere N; Gottesman I; Ho K; Kohli S; Teitelbaum I; Tytus R; Wharton S; Woo V; Hellsten T; Kuusela M; Sarti C; Strand J; Valli K; Erlinger R; Goelz S; Hauser KH; Hilgenberg J; Kaiser M; Marck C; Merfort F; Milek K; Paschen B; Rose L; Schlecht K; Wenzl Bauer V; Dudas M; Fulop G; Harcsa E; Kerenyi Z; Szőcs A; Takacs R; Babu T; Bandgar TR; Bantwal G; Bhagwat NM; Chatterjee S; Jain SM; John M; Kale S; Kanungo AK; Kumar A; Kumar H; Kumar SN; Lodha S; Majumder A; Mithal A; Murthy S; Sethi BK; Shah P; Sharma SK; Sivagnanam N; Velu S; Viswanathan V; Yajnik CS; Byrne M; O'Brien T; Aimaretti G; Baroni MG; D'Amico E; Giordano C; Sforza A; Tonolo G; Bebakar WM; Kamaruddin NA; Hussein Z; Mumtaz M; Sothiratnam R; Gonzalez Galvez G; Hernandez PA; Grineva E; Kalashnikova MF; Kulkova P; Krasilnikova EE; Kondrachenko S; Kunitsyna MA; Poley M; Sardinov R; Vorokhobina NV; Yurievna M; Zhdanova EA; Zhukova LA; Dalan R; Khoo EY; Sum CF; Cizova M; Martinka E; Schroner Z; Teplanova M; Tomasova L; Biermann E; Dulabh R; Khutsoane DT; Komati SM; Makan HA; Mayet L; Mitha EA; Padayachee T; Pillay S; Reddy J; Snyman HH; Siddique N; Trokis J; Bobillo ER; de la Cuesta C; Fernández MR; González AS; De Teresa Parreño L; Raya PM; de la Torre ML; Torres JF; Sheu WH; Sun JH; Yang CY; Deerochanawong C; Phornphutkul M; Suwanwalaikorn S; Sriwijitkamol A; Clark J; Downie P; Evans P; Furlong N; Gough S; Harper R; Harvey JN; Khan A; Leese G; McKinnon C; Narendran P; Patterson C; Raymond F; Singhal P; Smith P; Viljoen A; Willis T; Acampora M; Agaiby JM; Ahmed I; Allison JR; Altamirano D; Anderson MW; Andrawis N; Aroda VR; Ballard TV; Beavins J; Bedel GW; Bernstein R; Blaze K; Bode BW; Bononi PL; Broker RE; Buse JB; Butuk DJ; Camiscoli DJ; Canadas R; Castorino K; Cathcart H; Cha G; Chang A; Chappel CM; Cheema C; Chenore M; Cheung D; Christensen J; Chu JW; Chuck L; Cohen CD; Cohen K; Cho MH; Rivera Colon L; Condit J; Corbett B; Pearlstein R; Cox WR; Daboul NY; Deatkine D; Dunn LJ; Ellison HS; Feldman BN; Fidelholtz J; First B; Fishman N; Fogarty CM; Fraser NJ; Gabra N; Gaona RE; Gerety G; Gilman RM; Gonte WS; Gottschlich GM; Grant DM; Hewitt M; Hollander P; House BA; Huffman D; Jain RK; Johnson G; Jones SW; Kayne DM; Kimmel MA; Klonoff D; Knight H; Koontz D; Kutner ME; Lenhard JM; Liss JL; Litchfield WR; Lubin B; Lucas KJ; Lynn L; Lyons TJ; Macadams MR; Mach MQ; Maletz L; Mariano HG; Mayeda SO; Pratley RE; Madder R; Martinez GJ; Mcgarity WC Jr; Mckenzie WC; Meisner CR; Montenegro C; Moran JE; Morawski EJ; Moretto TJ; Mudaliar SR; Murray AV; Myers L; Odugbesan AO; Olivarez E; Pangtay D; Patel MB; Patel NR; Patel R; Perdomo A; Pritchett KL; Rasmussen B; Reed JC; Reeves ML; Reichman A; Rhee C; Rice LC; Risser J; Rodbard HW; Rosen R; Rosenstock J; Ryan EH; Schreiman RC; Scott RB; Selagamsetty MR; Shaughnessy J; Silver R; Simon HJ; Snyder B; Soufer J; Stegemoller RK; Sugimoto D; Thurman J; Tolia KK; Wagner R; Wahlen J; Webster DE; Weisbrot AJ; Whittier F; Winkle PJ; Woolley JH; Yeoman G; Zemel LR; Smith BP; Philis Tsimikas A; Weissman P; Kurland Wise J.; DOTTA, FRANCESCO |
| Contributors: | Gough, S. C.; Bode, B.; Woo, V.; Rodbard, H. W.; Linjawi, S.; Poulsen, P.; Damgaard, L. H.; Buse, J. B.; NN9068 3697 trial, Investigator; Donnelly, T; Gerstman, M; Linjawi, S; Park, K; Roberts, A; Shaw, Je; Wu, T; Aggarwal, N; Bowering, K; Chouinard, G; Deyoung, P; Dumas, R; Elliott, Tg; Frechette, A; Giguere, N; Gottesman, I; Ho, K; Kohli, S; Teitelbaum, I; Tytus, R; Wharton, S; Woo, V; Hellsten, T; Kuusela, M; Sarti, C; Strand, J; Valli, K; Erlinger, R; Goelz, S; Hauser, Kh; Hilgenberg, J; Kaiser, M; Marck, C; Merfort, F; Milek, K; Paschen, B; Rose, L; Schlecht, K; Wenzl Bauer, V; Dudas, M; Fulop, G; Harcsa, E; Kerenyi, Z; Szőcs, A; Takacs, R; Babu, T; Bandgar, Tr; Bantwal, G; Bhagwat, Nm; Chatterjee, S; Jain, Sm; John, M; Kale, S; Kanungo, Ak; Kumar, A; Kumar, H; Kumar, Sn; Lodha, S; Majumder, A; Mithal, A; Murthy, S; Sethi, Bk; Shah, P; Sharma, Sk; Sivagnanam, N; Velu, S; Viswanathan, V; Yajnik, C; Byrne, M; O'Brien, T; Aimaretti, G; Baroni, Mg; D'Amico, E; Dotta, Francesco; Giordano, C; Sforza, A; Tonolo, G; Bebakar, Wm; Kamaruddin, Na; Hussein, Z; Mumtaz, M; Sothiratnam, R; Gonzalez Galvez, G; Hernandez, Pa; Grineva, E; Kalashnikova, Mf; Kulkova, P; Krasilnikova, Ee; Kondrachenko, S; Kunitsyna, Ma; Poley, M |
| Publication Year: | 2014 |
| Collection: | Università degli Studi di Siena: USiena air |
| Description: | BACKGROUND: A fixed-ratio combination of the basal insulin analogue insulin degludec and the glucagon-like peptide-1 (GLP-1) analogue liraglutide has been developed as a once-daily injection for the treatment of type 2 diabetes. We aimed to compare combined insulin degludec-liraglutide (IDegLira) with its components given alone in insulin-naive patients. METHODS: In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day). IDegLira and insulin degludec were titrated to achieve a self-measured prebreakfast plasma glucose concentration of 4-5 mmol/L. The primary endpoint was change in HbA1c after 26 weeks of treatment, and the main objective was to assess the non-inferiority of IDegLira to insulin degludec (with an upper 95% CI margin of 0·3%), and the superiority of IDegLira to liraglutide (with a lower 95% CI margin of 0%). This study is registered with ClinicalTrials.gov, number NCT01336023. FINDINGS: 1663 adults (mean age 55 years [SD 10], HbA1c 8·3% [0·9], and BMI 31·2 kg/m(2) [4·8]) were randomly assigned, 834 to IDegLira, 414 to insulin degludec, and 415 to liraglutide. After 26 weeks, mean HbA1c had decreased by 1·9% (SD 1·1) to 6·4% (1·0) with IDegLira, by 1·4% (1·0) to 6·9% (1·1) with insulin degludec, and by 1·3% (1·1) to 7·0% (1·2) with liraglutide. IDegLira was non-inferior to insulin degludec (estimated treatment difference -0·47%, 95% CI -0·58 to -0·36, p |
| Document Type: | article in journal/newspaper |
| File Description: | STAMPA |
| Language: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/25190523; info:eu-repo/semantics/altIdentifier/wos/WOS:000347779800015; volume:2; issue:11; firstpage:885; lastpage:893; numberofpages:9; journal:THE LANCET DIABETES & ENDOCRINOLOGY; http://hdl.handle.net/11365/49365 |
| DOI: | 10.1016/S2213-8587(14)70174-3 |
| Availability: | http://hdl.handle.net/11365/49365; https://doi.org/10.1016/S2213-8587(14)70174-3 |
| Rights: | info:eu-repo/semantics/closedAccess |
| Accession Number: | edsbas.ACE1692E |
| Database: | BASE |