Search

Your search keyword '"Merfort, F"' showing total 6 results
Start Over Author "Merfort, F"
6 results on '"Merfort, F"'

3. 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

Author

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, and Kurland Wise, J.

Subjects
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
Abstract

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.

Published
2014

6. Efficacy and safety of flexible-dose vardenafil in men with type 1 diabetes and erectile dysfunction.

Author

Ziegler D, Merfort F, Van Ahlen H, Yassin A, Reblin T, and Neureither M

Subjects
Adult, Dose-Response Relationship, Drug, Double-Blind Method, Erectile Dysfunction etiology, Humans, Male, Middle Aged, Patient Satisfaction, Quality of Life, Sulfones administration & dosage, Surveys and Questionnaires, Treatment Outcome, Triazines administration & dosage, Vardenafil Dihydrochloride, Diabetes Mellitus, Type 1 complications, Erectile Dysfunction drug therapy, Imidazoles administration & dosage, Phosphodiesterase Inhibitors administration & dosage, Piperazines administration & dosage, Sexual Behavior drug effects
Abstract

Introduction: Erectile dysfunction (ED) affects up to 70% of men with diabetes, occurring with a higher prevalence in those with type 1 diabetes than with type 2 diabetes. Studies investigating treatment of ED in men with diabetes have largely been conducted in a total male population with diabetes. Limited data are available on the efficacy and safety of the potent oral phosphodiesterase-5 inhibitor vardenafil in men with ED and type 1 diabetes., Aims: To evaluate the safety and efficacy of flexible-dose vardenafil therapy in a prospective randomized study in phosphodiesterase 5 inhibitor-naïve subjects with type 1 diabetes and ED., Methods: In this multicenter, double-blind, placebo-controlled clinical trial, phosphodiesterase-5 inhibitor-naïve patients were randomized to receive placebo (N = 149) or flexible-dose (5-20 mg) (N = 153) vardenafil., Main Outcome Measure: Sexual Encounter Profile diary questions 2 and 3, concerning success rates of vaginal insertion and maintenance of erection to allow successful intercourse, respectively., Results: Vardenafil significantly improved mean success rates for Sexual Encounter Profile 2 and 3 compared with baseline and placebo at 4, 8, and 12 weeks (P < 0.0001, intention to treat and last observation carried forward). These rates were unaffected by stratification into distinct subsets according to the level of HbA(1c) (HbA(1c) < 7%, good glycemic control; HbA(1c) >7- < or = 8%, moderate glycemic control; and HbA(1c) > 8%, poor glycemic control). Vardenafil treatment also significantly improved the Erectile Function domain score (P < 0.0001) of the International Index of Erectile Function compared with placebo, in addition to scores for the other individual domains of the International Index of Erectile Function. The most commonly reported treatment-emergent adverse events were headache (3.1%) and flushing (2.5%), which were mild to moderate and transient in nature., Conclusion: These data suggest that vardenafil significantly improves erectile function in men with type 1 diabetes and is well tolerated, regardless of the level of glycemic control.

Published
2006
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results