An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: The A1chieve study

Aim: The aim of A(1)chieve was to remedy the deficit of data on the efficacy and safety of insulin analogues in routine clinical care in less well-resourced/newly developed countries. Methods: A non-interventional, 6-month, observational study of 66,726 people with type 2 diabetes, both insulin users and non-insulin users, started on insulin detemir, insulin aspart or biphasic insulin aspart in 28 countries across four continents. Results: Baseline HbA(1c) (+/-SD) was poor: 9.5 +/- 1.8%. At 6 months, improvement was -2.1 +/- 1.7% in the entire cohort, and -2.2 +/- 1.7% and -1.8 +/- 1.7% for prior non-insulin users and insulin users. All three analogue therapies gave similar results, again independently of prior insulin use, but also from seven pre-specified country groupings. Overall, hypoglycaemia did not increase in those new to insulin, and fell in those switching insulins. There was no change in body weight (-0.1 + 3.7 kg), while lipid profile and systolic blood pressure (-6.3 +/- 17.1 mmHg) were improved. Conclusions: Beginning insulin analogue therapy in people with type 2 diabetes and poor blood glucose control is associated with marked improvements in diverse aspects of vascular risk factor profile without evidence of clinically significant safety or tolerability problems. (C) 2011 Elsevier Ireland Ltd. All rights reserved.