The Safety and Efficacy of Biphasic Insulin Aspart 30 (Biasp 30) in Iranians With Type 2 Diabetes: An Open-Label, Non-Randomised, Multi-Centre Observational Study - the Iran Subgroup of the Improve™ Study Pubmed



Esteghamati A¹ ; Rajabian R² ; Amini M³ ; Bahrami A⁴ ; Khamseh ME⁵ ; Afkhamiardekani M⁶ ; Rizi EP⁷ Show Affiliations
Source: Endokrynologia Polska Published:2010

Abstract

Introduction: To evaluate the clinical profile of BIAsp 30 (30% soluble insulin aspart, 70% protamine-crystallized insulin aspart) (NovoMix®30) in type 2 diabetes patients in routine clinical practice in Iran. Material and methods: IMPROVE™ 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 HbA1c 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.