المؤلفون: Pi-Sunyer, Xavier, Astrup, Arne, Fujioka, Ken, Greenway, Frank, Halpern, Alfredo, Krempf, Michel, Lau, David C. W., le Roux, Carel W., Ortiz, Violante, Jensen, Christine Bjorn, Wilding, John P. H., Hamann A, Barakat A, Blüher M, Linn T, DALLE MOLLE, ALBERTO, Segner A, Stübler P, Tosch-Sisting R, Pacini F, Santini F, Marchesini G, Rotella CM, Invitti C, Vettor R, Buscemi S, Raya PM, Freijoo FC, de Barbará RG, Carraro R, Bobillo ER, de la Cuesta C, Farsang C, Csaszar A, Zahorska-Markiewicz B, Pupek-Musialik D, Franek E, Ostrowska L, Olszanecka-Glinianowicz M, Lalic N, Micic D, Ludvik B, Paulweber B, Prager R, Scheen A, Van Gaal L, Astrup AV, Hermansen K, Madsbad S, Rissanen A, Nieminen S, Savolainen M, Krempf M, Romon M, Laville M, Marre M, Mira R, Finucane F, Veenendaal A, van Berkum F, Johannsson-Vidarsdóttir S, Van de Walle V, Meesters E, Hjelmesæth J, Klemsdal TO, Kulseng B, Bach-Kliegel B, Laederach K, Villiger L, Golay A, Bilz S, Sathyapalan T, Bain S, Kumar S, Le Roux CW, Lean ME, McGowan B, Rehman T, Wilding J, Wittert G, Caterson I, Proietto J, Prins J, Geloneze Neto B, Gross JL, Chacra AR, Halpern A, Suplicy Hde A, Chow FC, Thacker HP, Chadha M, Chandalia H, Unnikrishnan A, Kalra S, Deshpande N, Shunmugavelu M, Deshmukh VC, Maislos M, Lieberman GS, Shimon I, Stern N, Nabriski D, Karnieli E, Shehadeh N, Gonzalez-Galvez G, Arechavaleta-Granell Mdel R, Violante Ortiz RM, Franco GM, Gurieva I, Suplotova LA, Troshina E, Ruyatkina LA, Voychik EA, Martsevich S, Startseva MA, Seeber ME, Badat A, Ellis G, Altuntas Y, Guler S, Ulgen E, Delibasi T, Chetty T, Hart R, Janzen J, Labonte I, Lau D, Liutkus J, O'Keefe D, Padwal R, Ransom TP, Tytus R, Weisnagel SJ, Adler J, Aqua K, Aronoff SL, Bedel GW, Blevins TC, Blumenau J, Brockmyre AP, Call RS, Canadas R, Chaykin LB, Cohen K, Conrow JK, Davis MG, Downey HJ, Drosman SR, Duckor S, Farmer H, Farrell J, Fehnel S, Finneran MP, Forbes R, Forker A, Fredrick M, Fujioka K, Geller SA, Gill S, Glaser L, Greco SN, Greenway FL, Harper W, Herman L, Hoekstra J, Ingebretsen R, Ison R, Jain RK, Kaplan R, Kaster SR, Haase GA, Kerzner B, Kirstein JL, Koltun W, Krieger DR, Lewis CE, Madder R, Marple RN, McDermott EJ, Mello CJ, Miller AB, Mullen J, Nardandrea J, O'Neil P, Pi-Sunyer F, Pucillo RM, Rhee C, Redrick S, Pardini A, Rothman J, Rubino DM, Sellers G, Smith T, Byars WD, Soufer J, Sussman AM, Patrick K, Schramm EL, Van Cleeff M, Berg SR, Wyatt HR, Simon JA.

المساهمون: Pi-Sunyer, Xavier, Astrup, Arne, Fujioka, Ken, Greenway, Frank, Halpern, Alfredo, Krempf, Michel, Lau, David C. W., le Roux, Carel W., Ortiz, Violante, Jensen, Christine Bjorn, Wilding, John P. H., Hamann, A, Barakat, A, Blüher, M, Linn, T, DALLE MOLLE, Alberto, Segner, A, Stübler, P, Tosch-Sisting, R, Pacini, F, Santini, F, Marchesini, G, Rotella, Cm, Invitti, C, Vettor, R, Buscemi, S, Raya, Pm, Freijoo, Fc, de Barbará, Rg, Carraro, R, Bobillo, Er, de la Cuesta, C, Farsang, C, Csaszar, A, Zahorska-Markiewicz, B, Pupek-Musialik, D, Franek, E, Ostrowska, L, Olszanecka-Glinianowicz, M, Lalic, N, Micic, D, Ludvik, B, Paulweber, B, Prager, R, Scheen, A, Van Gaal, L, Astrup, Av, Hermansen, K, Madsbad, S, Rissanen, A, Nieminen, S, Savolainen, M, Krempf, M, Romon, M, Laville, M, Marre, M, Mira, R, Finucane, F, Veenendaal, A, van Berkum, F, Johannsson-Vidarsdóttir, S, Van de Walle, V, Meesters, E, Hjelmesæth, J, Klemsdal, To, Kulseng, B, Bach-Kliegel, B, Laederach, K, Villiger, L, Golay, A, Bilz, S, Sathyapalan, T, Bain, S, Kumar, S, Le Roux, Cw, Lean, Me, Mcgowan, B, Rehman, T, Wilding, J, Wittert, G, Caterson, I, Proietto, J, Prins, J, Geloneze Neto, B, Gross, Jl, Chacra, Ar, Halpern, A, Suplicy Hde, A, Chow, Fc, Thacker, Hp, Chadha, M, Chandalia, H, Unnikrishnan, A, Kalra, S, Deshpande, N, Shunmugavelu, M, Deshmukh, Vc, Maislos, M, Lieberman, G, Shimon, I

مصطلحات موضوعية: Adult, Blood Glucose, Body Mass Index, Combined Modality Therapy, Counseling, Diarrhea, Diet, Reducing, Double-Blind Method, Exercise, Female, Glucagon-Like Peptide 1, Human, Hypoglycemic Agent, Injections, Subcutaneou, Liraglutide, Male, Middle Aged, Nausea, Obesity, Weight Lo, Medicine (all)

الوصف: BACKGROUND Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagonlike peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. METHODS We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. RESULTS At baseline, the mean (±SD) age of the patients was 45.1±12.0 years, the mean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P<0.001, with last-observation-carried-forward imputation). A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P<0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P<0.001). The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of the patients in the liraglutide group and in 5.0% of the patients in the placebo group. CONCLUSIONS In this study, 3.0 mg of liraglutide, as an ...

وصف الملف: ELETTRONICO

العلاقة: info:eu-repo/semantics/altIdentifier/pmid/26132939; info:eu-repo/semantics/altIdentifier/wos/WOS:000357218700004; volume:373; issue:1; firstpage:11; lastpage:22; numberofpages:12; journal:NEW ENGLAND JOURNAL OF MEDICINE; http://hdl.handle.net/11568/855260Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-84936166069

الإتاحة: https://doi.org/10.1056/NEJMoa1411892Test
http://hdl.handle.net/11568/855260Test

المؤلفون: 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, 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, 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.

المصدر: The lancet. Diabetesendocrinology. 2(11)

مصطلحات موضوعية: Insulin degludec, Blood Glucose, Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Urology, Type 2 diabetes, law.invention, Endocrinology, Randomized controlled trial, law, Glucagon-Like Peptide 1, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Glycated Hemoglobin, Liraglutide, business.industry, Insulin, Middle Aged, medicine.disease, Metformin, Insulin, Long-Acting, Drug Combinations, Treatment Outcome, Diabetes Mellitus, Type 2, Female, business, Pioglitazone, medicine.drug

الوصف: 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.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 NCT01336023.1663 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, p0·0001) and superior to liraglutide (-0·64%, -0·75 to -0·53, p0·0001). IDegLira was generally well tolerated; fewer participants in the IDegLira group than in the liraglutide group reported gastrointestinal adverse events (nausea 8·8 vs 19·7%), although the insulin degludec group had the fewest participants with gastrointestinal adverse events (nausea 3·6%). We noted no clinically relevant differences between treatments with respect to standard safety assessments, and the safety profile of IDegLira reflected those of its component parts. The number of confirmed hypoglycaemic events per patient year was 1·8 for IDegLira, 0·2 for liraglutide, and 2·6 for insulin degludec. Serious adverse events occurred in 19 (2%) of 825 patients in the IDegLira group, eight (2%) of 412 in the insulin degludec group, and 14 (3%) of 412 in the liraglutide group.IDegLira combines the clinical advantages of basal insulin and GLP-1 receptor agonist treatment, resulting in improved glycaemic control compared with its components given alone.Novo Nordisk.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e5e3f1a1b777ebd135e0281ee53bf677Test
https://pubmed.ncbi.nlm.nih.gov/25190524Test

المؤلفون: 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

المساهمون: 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

الوصف: 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<0·0001) and superior to liraglutide (-0·64%, -0·75 to -0·53, p<0·0001). IDegLira was generally well tolerated; fewer participants in the IDegLira group than in the liraglutide group reported gastrointestinal adverse events (nausea 8·8 vs 19·7%), although the insulin degludec group had the fewest participants with gastrointestinal adverse events (nausea 3·6%). We noted no clinically relevant ...

وصف الملف: STAMPA

العلاقة: 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/11365/49365Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-84922519772

الإتاحة: https://doi.org/10.1016/S2213-8587Test(14)70174-3
http://hdl.handle.net/11365/49365Test