An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: The A1chieve study
Diabetes Research and Clinical Practice, Issue 3, Volume 94, pages 352 - 363
Received 20 September 2011, Revised 10 October 2011, Accepted 13 October 2011, Published online ноя-2011
The aim of A1chieve 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.
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.
Baseline HbA1c (±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.
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.
Keywords: Observational study, Type 2 diabetes, Insulin analogues, Efficacy, Hypoglycaemia.