The A1 chieve study - an observational non-interventional study of patients with type 2 diabetes mellitus initiating or switched to insulin analogue therapy: subgroup analysis of the Gulf population.
AIM: To evaluate the safety and effectiveness of insulin analogues (insulin aspart, insulin detemir and biphasic insulin aspart 30, alone or in combination) in type 2 diabetes mellitus (T2DM) patients in routine clinical practice in the Gulf as a subgroup of the A(1) chieve multi-national study. METHODS: A total of 10,704 T2DM Gulf patients with uncontrolled T2DM on oral antidiabetics +/- insulins other than insulin aspart, insulin detemir or biphasic insulin aspart 30, who initiated or switched to study insulins were included and followed up for 24 weeks in the context of the A(1) chieve study. RESULTS: Baseline HbA(1c) (+/- SD) was poor: 9.7 +/- 1.7%. At Week 24, an improvement in HbA(1c) of -2.3 +/- 1.6% was observed in the entire cohort, and -2.4 +/- 1.5% and -2.1 +/- 1.7% for insulin-naive patients and prior insulin users respectively. Overall, rates of hypoglycaemia increased in those new to insulin therapy, whereas a reduction was observed in those switching from other insulins. A marginal reduction in body weight (-0.8 +/- 4.4 kg) was noted in the entire cohort, whereas the overall lipid profile and systolic blood pressure (-6.2 +/- 15.3 mmHg) improved. CONCLUSIONS: Initiating or switching to insulin analogues was well tolerated and resulted in significant improvements in glycaemic control in T2DM patients in the Gulf......