AIM: This 3-month study compared the effect on overall glycemic control of adding biphasic insulin aspart 30 (BIAsp30) and premixed human insulin 30/70 (BHI30) to metformin (met) in insulin-naïve, obese patients (30 males/20 females) with Type 2 diabetes (T2DM). MATERIAL/ SUBJECTS: At baseline, patients had a mean age of 58.7 yr, glycated hemoglobin (HbA1c) 9.5%, and body mass index 34+/-2 kg/m2. Patients received either twice-daily BIAsp30 (no.=20) or twice-daily BHI30 (no.=30), and continued to receive maximal doses (2000 mg) of met for the duration of the study, but sulphonylurea oral antidiabetic drugs were discontinued. Primary efficacy endpoint was the change in HbA1c in both groups at study end. Safety endpoints included hypoglycemic episodes and weight gain. RESULTS: Both groups reduced HbA1c by end of trial: BIAsp30 + met by 2.5% [2.16-2.86%; 95% confidence interval (CI)]; BHI30 + met by 1.18% (0.98- 1.39%; 95% CI), giving a significantly better HbA1c reduction with BIAsp30 + met (1.33%; p<0.05). Post-prandial plasma glucose decreased in both groups, by 6.38 mmol/l in patients treated with BIAsp30 + met, and by 4.34 mmol/l in those treated with BHI30 + met (p<0.05). Fasting plasma glucose also decreased in both groups, with a slightly larger decrease seen in BIAsp30 patients than in BHI30 patients (7.36 mmol/l at end of study vs 7.82 mmol/l; p=ns). Subjects treated with BIAsp30 gained less weight than those receiving BHI30 (0.3+/-0.1 kg vs 1.2+/-0.4 kg). There was no significant difference in the frequency or number of hypoglycemic episodes between groups. CONCLUSIONS: Adding BIAsp30 to met in obese patients with T2DM results in better glycemic control and less weight gain than adding BHI30.
RCT Entities:
AIM: This 3-month study compared the effect on overall glycemic control of adding biphasic insulin aspart 30 (BIAsp30) and premixed human insulin 30/70 (BHI30) to metformin (met) in insulin-naïve, obesepatients (30 males/20 females) with Type 2 diabetes (T2DM). MATERIAL/ SUBJECTS: At baseline, patients had a mean age of 58.7 yr, glycated hemoglobin (HbA1c) 9.5%, and body mass index 34+/-2 kg/m2. Patients received either twice-daily BIAsp30 (no.=20) or twice-daily BHI30 (no.=30), and continued to receive maximal doses (2000 mg) of met for the duration of the study, but sulphonylurea oral antidiabetic drugs were discontinued. Primary efficacy endpoint was the change in HbA1c in both groups at study end. Safety endpoints included hypoglycemic episodes and weight gain. RESULTS: Both groups reduced HbA1c by end of trial: BIAsp30 + met by 2.5% [2.16-2.86%; 95% confidence interval (CI)]; BHI30 + met by 1.18% (0.98- 1.39%; 95% CI), giving a significantly better HbA1c reduction with BIAsp30 + met (1.33%; p<0.05). Post-prandial plasma glucose decreased in both groups, by 6.38 mmol/l in patients treated with BIAsp30 + met, and by 4.34 mmol/l in those treated with BHI30 + met (p<0.05). Fasting plasma glucose also decreased in both groups, with a slightly larger decrease seen in BIAsp30 patients than in BHI30patients (7.36 mmol/l at end of study vs 7.82 mmol/l; p=ns). Subjects treated with BIAsp30 gained less weight than those receiving BHI30 (0.3+/-0.1 kg vs 1.2+/-0.4 kg). There was no significant difference in the frequency or number of hypoglycemic episodes between groups. CONCLUSIONS: Adding BIAsp30 to met in obesepatients with T2DM results in better glycemic control and less weight gain than adding BHI30.
Authors: Lars Rydén; Eberhard Standl; Małgorzata Bartnik; Greet Van den Berghe; John Betteridge; Menko-Jan de Boer; Francesco Cosentino; Bengt Jönsson; Markku Laakso; Klas Malmberg; Silvia Priori; Jan Ostergren; Jaakko Tuomilehto; Inga Thrainsdottir; Ilse Vanhorebeek; Marco Stramba-Badiale; Peter Lindgren; Qing Qiao; Silvia G Priori; Jean-Jacques Blanc; Andrzej Budaj; John Camm; Veronica Dean; Jaap Deckers; Kenneth Dickstein; John Lekakis; Keith McGregor; Marco Metra; João Morais; Ady Osterspey; Juan Tamargo; José Luis Zamorano; Jaap W Deckers; Michel Bertrand; Bernard Charbonnel; Erland Erdmann; Ele Ferrannini; Allan Flyvbjerg; Helmut Gohlke; Jose Ramon Gonzalez Juanatey; Ian Graham; Pedro Filipe Monteiro; Klaus Parhofer; Kalevi Pyörälä; Itamar Raz; Guntram Schernthaner; Massimo Volpe; David Wood Journal: Eur Heart J Date: 2007-01 Impact factor: 29.983
Authors: I Schmoelzer; A de Campo; H Pressl; H Stelzl; P Dittrich; K Oettl; T C Wascher Journal: Exp Clin Endocrinol Diabetes Date: 2005-03 Impact factor: 2.949
Authors: Philip Raskin; Elsie Allen; Priscilla Hollander; Andrew Lewin; Robert A Gabbay; Peter Hu; Bruce Bode; Alan Garber Journal: Diabetes Care Date: 2005-02 Impact factor: 19.112
Authors: C Coscelli; G Iacobellis; C Calderini; R Carleo; M Gobbo; U Di Mario; F Leonetti; A Galluzzo; V Pirrone; M Lunetta; P Casale; F Paleari; C Falcelli; D Valle; A Camporeale; D Merante Journal: Acta Diabetol Date: 2003-12 Impact factor: 4.280
Authors: Mark L Warren; Martin J Conway; Leslie J Klaff; Julio Rosenstock; Elsie Allen Journal: Diabetes Res Clin Pract Date: 2004-10 Impact factor: 5.602
Authors: S Shah; M Benroubi; V Borzi; J Gumprecht; R Kawamori; J Shaban; M Shestakova; Y Wenying; P Valensi Journal: Int J Clin Pract Date: 2009-02-05 Impact factor: 2.503