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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, Volume 94, Issue 3, December 2011, Pages 352 - 363
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.
a Institute of Cellular Medicine – Diabetes, Newcastle University, Newcastle upon Tyne, UK
b Internal Medicine, Hai Aljamea Hospital, Jeddah, Saudi Arabia
c Endocrine Research Center (Firouzgar), Institute of Endocrinology & Metabolism, Tehran University of Medical Sciences, Tehran, Iran
d Instituto Jalisciense de Investigacion en Diabetes y Obesidad, Guadalajara, Mexico
e Novo Nordisk International Operations A/S, Zürich, Switzerland
f China-Japan Friendship Hospital, Beijing, China
⁎ Corresponding author at: Institute of Cellular Medicine – Diabetes, University of Newcastle upon Tyne, Framlington Place, Newcastle upon Tyne NE2 4HH, UK. Tel.: +44 191 222 7154; fax: +44 191 222 0723.
☆ This study was funded by Novo Nordisk.
☆☆ Clinical trial registration: Clinicaltrials.gov, NCT00869908.
© 2011 Elsevier Ireland Ltd, All rights reserved.