Abstract

Introduction: To evaluate the clinical profile of BIAsp 30 (30 soluble insulin aspart, 70 protamine-crystallized insulin aspart) (NovoMix (R) 30) in type 2 diabetes patients in routine clinical practice in Iran. Material and methods: IMPROVE (TM) was a 26-week, multinational, open-label, non-randomized study in patients with type 2 diabetes. The safety and efficacy of BIAsp 30 were assessed at baseline and at 13 and 26 weeks. The titration of BIAsp30 was at the physician's discretion. Results: In Iran, 478 patients (47 male) previously treated with oral antidiabetic drugs (OADs) (N = 159, 33.3) and/or insulin other than BIAsp30 (N = 317, 66.3) or a few who were treatment-naive (N = 2, 0.4) participated in the study. After 26 weeks of treatment with BIAsp 30, the rate of reported major hypoglycaemic episodes was reduced by 88.1 from baseline (baseline v. Week 26: 0.303 v. 0.037 episodes/pt-year; p < 0.001). No significant differences in minor hypoglycaemic episodes between baseline and Week 26 were found. Glycaemic control was significantly improved from baseline to Week 26 with a mean HbA(1c) reduction of 1.2 +/- 1.9. Patients' quality of life as measured by the DiabMedSat questionnaire significantly improved from baseline (58.1) to the end of the study (75.4, p < 0.001). Conclusions: BIAsp 30 therapy appeared safe and effective and improved quality of life in Iranian patients with type 2 diabetes after 26 weeks of treatment. (Pol J Endocrinol 2010; 61 (4): 364-370)