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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
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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-naïve (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. (Pol J Endocrinol 2010; 61 (4): 364-370)
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-naïve (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. (Pol J Endocrinol 2010; 61 (4): 364-370)
Keywords
type 2 diabetes; insulin aspart; quality of life
About this articleTitle
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
Journal
Issue
Article type
Original paper
Pages
364-370
Published online
2010-08-31
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675
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3020
Bibliographic record
Endokrynol Pol 2010;61(4):364-370.
Keywords
type 2 diabetes
insulin aspart
quality of life
Authors
Alireza Esteghamati
Reza Rajabian
Masoud Amini
Amir Bahrami
Mohammad Ebrahim Khamseh
Mohammad Afkhami-Ardekani
Ehsan Parvaresh Rizi
