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.