The A1chieve study: a 60 000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice
Diabetes Research and Clinical Practice, Supplement 1, Volume 88, pages S11 - S16
Published online Dec-2010
While evidenced-based guidelines promote glycated hemoglobin (HbA1c) targets <7.0% in order to reduce the long-term risk of diabetic complications, many individuals with type 2 diabetes do not achieve these targets. Fear of hypoglycemia provides a major barrier to improving blood glucose control as a result of delayed insulin initiation and failure to appropriately titrate insulin following initiation. Modern insulin analogs were designed to achieve improved blood glucose control with similar hypoglycemic risk compared with non-analog insulins (or similar blood glucose control with reduced hypoglycemic risk). While this has been demonstrated in randomized controlled trials, there is a need to confirm these findings in an everyday clinical setting. The A1chieve study will evaluate adverse events and effectiveness of premix (biphasic insulin aspart 30 [NovoMix 30]), basal (insulin detemir [Levemir]), and meal-time (insulin aspart [NovoRapid]) insulin analogs in people with type 2 diabetes in near-routine clinical practice. A1chieve is an international, prospective, multi-center, open-label, non-interventional, 24-week study of people with type 2 diabetes using an insulin analog. The study will recruit 60 000 people from 30 countries across four continents (Asia, Africa, South America, and Europe). The primary aim of the study is to assess the adverse event profile of the study insulins in routine clinical practice, including rates of hypoglycemia. In addition, effectiveness (HbA1c, fasting plasma glucose, and postprandial plasma glucose) and patient quality of life outcomes will be measured. Comprehensive epidemiological data will be collected at baseline, including recent plasma glucose results and hypoglycemic episodes, prevalence of diabetes-related complications, and measures of current standards of care. Thus, A1chieve should provide important information about how insulin analogs perform in daily clinical practice.
Keywords: Type 2 diabetes, Observational study, A1chieve, Insulin.
- 1 IM Stratton, AI Adler, HA Neil, DR Matthews, SE Manley, CA Cull, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405-412
- 2 RR Holman, SK Paul, MA Bethel, DR Matthews, HA Neil. 10-year follow-up of intensive glucose control in type 2 diabetes. N. Engl. J. Med.. 2008;359:1577-1589
- 3 KK Ray, SR Seshasai, S Wijesuriya, R Sivakumaran, S Nethercott, D Preiss, S Erqou, N Sattar. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Lancet. 2009;373(9677):1765-1772
- 4 FM Turnbull, C Abraira, RJ Anderson, RP Byington, JP Chalmers, WC Duckworth, GW Evans, HC Gerstein, RR Holman, TE Moritz, BC Neal, T Ninomiya, AA Patel, SK Paul, F Travert, M Woodward. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia. 2009;52(11):2288-2298
- 5 IDF Clinical Guidelines Task Force. Global guideline for Type 2 diabetes (International Diabetes Federation, Brussels, 2005)
- 6 SH Saydah, J Fradkin, CC Cowie. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-342
- 7 JB Saaddine, B Cadwell, EW Gregg, MM Engelgau, F Vinicor, G Imperatore, et al. Improvements in diabetes processes of care and intermediate outcomes: United States, 1988–2002. Ann. Intern. Med.. 2006;144:465-474
- 8 F Elgrably, D Costagliola, AJ Chwalow, P Varenne, G Slama, G Tchobroutsky. Initiation of insulin treatment after 70 years of age: patient status 2 years later. Diabet. Med.. 1991;8:773-777
- 9 M Peyrot, RR Rubin, T Lauritzen, SE Skovlund, FJ Snoek, DR Matthews, et al. International DAWN Advisory Panel. Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care. 2005;28:2673-2679
- 10 M Korytkowski. When oral agents fail: practical barriers to starting insulin. Int. J. Obes. Relat. Metab. Disord.. 2002;26(Suppl 3):S18-S24
- 11 K Horvath, K Jeitler, A Berghold, SH Ebrahim, TW Gratzer, J Plank, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst. Rev.. 2007; Apr 18;:2 10.1002/14651858.CD005613.pub3 CD005613.
- 12 LA Bazzano, LJ Lee, K Reynolds, JA Jackson, V Fonseca. Safety and efficacy of glargine compared with NPH insulin for the treatment of Type 2 diabetes: a meta-analysis of randomized controlled trials. Diabet. Metab.. 2008;25:924-932
- 13 A Philis-Tsimikas, G Charpentier, P Clauson, G Martinez Ravn, VL Roberts, B Thorsteinsson. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin. Ther.. 2006;28:1569-1581
- 14 W Yang, A Zilov, P Soewondo, OM Bech, F Sekkal, PD Home. Observational studies: going beyond the boundaries of randomized controlled trials. Diabetes Res. Clin. Pract.. 2010; (in preparation)
- 15 World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Last amended with Note of Clarification on Paragraph 29 by the WMA General Assembly, Washington 2002, and Note of Clarification on Paragraph 30 by the WMA General assembly, Tokyo 2004.
- 16 R Brooks. EuroQol: the current state of play. Health Policy. 1996;37:53-72
- 17 E von Elm, DG Altman, M Egger, SJ Pocock, PC Gøtzsche, JP Vandenbroucke. STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J. Clin. Epidemiol.. 2008;61:344-349
- 18 L Niskanen, A Virkamäki, JB Hansen, T Saukkonen. Fasting plasma glucose variability as a marker of nocturnal hypoglycemia in diabetes: Evidence from the PREDICTIVE study. Diabetes Res. Clin. Pract.. 2009;86:e15-e18
- 19 A Dornhorst, HJ Lüddeke, S Sreenan, C Koenen, JB Hansen, A Tsur, et al. Safety and efficacy of insulin detemir in clinical practice: 14-week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVE European cohort. Int. J. Clin. Pract.. 2007;61:523-528
- 20 P Valensi, M Benroubi, V Borzi, J Gumprecht, R Kawamori, J Shaban, et al. IMPROVE Study Group Expert Panel. The IMPROVE study - a multinational, observational study in type 2 diabetes: baseline characteristics from eight national cohorts. Int. J. Clin. Pract.. 2008;62:1809-1819
- 21 M Shestakova, OM Bech, MS Momani. Study design and baseline characteristics of patients in the PRESENT study. Diabetes Res. Clin. Pract.. 2008;81(Suppl 1):S3-S9
- 22 RR Holman, KI Thorne, AJ Farmer, MJ Davies, JF Keenan, S Paul, et al. 4-T Study Group. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N. Engl. J. Med.. 2007;357:1716-1730
a Department of Endocrinology, S.L. Raheja Hospital, Mumbai, India
b Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
c Endocrinology Section, Bader Medical Complex, Amman, Jordan
d Novo Nordisk Region International Operations A/S, Zurich, Switzerland
e National Centre for Diabetes & Endocrinology, Tripoli, Libya
Correspondence to: Dr. Praful N. Chakkarwar, Novo Nordisk Region International Operations A/S, Andreasstrasse 15, Zurich, Oerlikon CH-8050, Switzerland
© 2010 Elsevier Ireland Ltd, All rights reserved.