A1chieve is the largest observational study of insulin analogue therapy ever conducted. The study enrolled a total of 66,726 patients with type 2 diabetes from 28 countries across Asia, Africa, Europe, and Latin America and evaluated the safety and effectiveness of three Novo Nordisk insulin analogues in routine clinical practice. The study collected a wealth of region-specific data on the use of insulin analogues in the management of patients with type 2 diabetes at various stages of disease progression. Those data are now available to clinicians and researchers worldwide via the A1chieve Resource Centre at www.a1chieve.com. The Centre provides an unprecedented level of detailed data and customizable downloadable reports on the tolerability and effectiveness of insulin analogues and patient outcomes.
A1chieve Study Objectives
In randomized clinical trials, insulin analogues have demonstrated an ability to improve glycemic control with a significant reduction in the risk of hypoglycemia or without increasing body weight compared to human insulin preparations.1 However, the results achievable in randomized trials are often not generalizable to other populations and circumstances. In randomized trials, treatment is provided to carefully selected patients in highly structured, monitored, and controlled clinical settings. Such factors are not reproducible in routine clinical practice, and the results of clinical trials, therefore, may not adequately reflect the outcomes achievable in other environments, especially in impoverished and newly developed countries. The A1chieve study was designed to specifically gather data on the safety and effectiveness of insulin analogues outside the clinical trial setting in non-Western, newly developed countries and countries with limited resources. There are 234 million people with diabetes living in the 28 countries that participated in the A1chieve study. This is nearly 64% of a total of 366 million people with diabetes worldwide.2 Thus, the insight and understanding into the epidemiology of diabetes in those countries, usually quite scarce on data, are of great importance for the medical community.
A1chieve was a 24-week, noninterventional, international, prospective, multicenter observational study. The study enrolled 66,726 patients with type 2 diabetes who had started therapy with basal insulin detemir (Levemir®), bolus insulin aspart (NovoRapid®), and biphasic insulin aspart 30 (NovoMix® 30), alone or in combination. Patients taking any additional prior or current medications were eligible for inclusion. The study was conducted at 3,166 centers in 28 countries in Asia, Africa, Latin America, and Europe. These broad regions were subdivided into seven more-specific geographic regions: China, South Asia, East Asia, North Africa, the Middle East/Gulf, Latin America, and Russia (Table).
Results from the study were published in the journal Diabetes Research and Clinical Practice in December 2011. Overall, insulin analogues produced substantial improvements in blood glucose levels. Baseline glycated hemoglobin (HbA1c) was 9.5%. At 6 months, there was a 2.1% improvement (decrease) for the entire cohort (to 7.4%, P<0.001). For patients with no prior insulin use, there was a 2.2% improvement and for those with previous insulin use, a 1.8% improvement in HbA1c levels (Figure 1).1 Overall, hypoglycaemia did not increase in those new to insulin, and fell in those switching insulins (Figure 2).1 Insulin analogue therapy was also associated with a significant improvement in health-related quality of life measured using the EQ-5D questionnaire at baseline and 24 weeks (increase from 63.4 points to 77.2 points, P<0.001) (Figure 3).3
These clinical and quality-of-life outcomes were consistent across the seven study regions. However, there were geographic differences in starting insulin doses, reductions in HbA1C levels, and overall hypoglycemia rates. There were also regional patterns of change in systolic blood pressure and levels of serum triglycerides and low-density lipoprotein cholesterol. The data are of immense interest when it comes to studying different patient profiles and choice of a particular insulin or insulin regimen that consider various genotypic and phenotypic variations across the globe. Identifying, analyzing, and understanding the details of region-specific data and differences among regions are now possible with the A1chieve Resource Centre.
The A1chieve Resource Centre
The A1chieve Resource Centre comprises the online A1chieve database. It is published on the Web site of the journal Diabetes Research and Clinical Practice with the support of Novo Nordisk. It is a free-access, multipurpose Web site: A1chieve study results are presented and disseminated through the Web site in the form of downloadable journal articles, videos, and other media, and physicians and researchers can use the Web site to view and generate custom reports from the A1chieve database. The Web site provides background information about the trial’s methods, outcomes, and investigators and includes a glossary, but the key, unique interactive feature is the Reports Generator.