Clinical experience with insulin detemir: Results from the Indonesian cohort of the international A1chieve study
Diabetes Research and Clinical Practice, pages S47 - S53
Published online Aug-2013
To determine the safety and efficacy of insulin detemir in Indonesian patients with type 2 diabetes (T2D) as a sub-analysis of the 24-week, prospective, multinational, non-interventional A1chieve study.
This study included 477 Indonesian T2D patients starting insulin detemir at the discretion of their physicians. Safety and efficacy was measured in routine clinical practice at baseline, interim (around 12 weeks from baseline) and final (around 24 weeks from baseline) visit.
At baseline the mean age, duration of diabetes and mean BMI were 55.3±8.5 years, 5.9±4.0 years and 24±3.6kg/m2, respectively. Of these patients, 78% were insulin-naive and 22% were prior insulin users. Glycaemic control was poor at baseline. After 24 weeks, significant reductions were observed in mean HbA1c (2.2%, p < 0.001), fasting plasma glucose (90.0 mg/dL, p < 0.001) and postprandial plasma glucose (115.4 mg/dL, p < 0.001) levels, in the entire cohort. Similar significant reductions were also seen in insulin-naive patients and prior insulin users. In the entire cohort, 32.5% patients achieved HbA1c levels <7.0% while 32.0% insulin-naive patients and 33.9% prior insulin users achieved this target after 24 weeks. No hypoglycaemic events were reported in the entire cohort. Modest increase in body weight was noted in the insulin-naive group, while mean body weight decreased in prior insulin users after 24 weeks of insulin detemir therapy.
This sub-analysis suggests that insulin detemir can be a safe and effective option for initiating insulin therapy in people with T2D in Indonesia.
Keywords: Insulin detemir, Indonesia, A1chieve.
- 1 A Ramachandran, C Snehalatha, AS Shetty, A Nanditha. Trends in prevalence of diabetes in Asian countries. World J Diabetes. 2012;3(6):110-117 Crossref.
- 2 International Diabetes Federation. IDF Diabetes Atlas. 5th edn. Brussels, Belgium; 2011, updated 14 November 2012.
- 3 P Home, NE Naggar, M Khamseh, G Gonzalez-Galvez, C Shen, P Chakkarwar, et al. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: the A1chieve study. Diabetes Res Clin Pract. 2011;94(3):352-363 Abstract, Full-text, PDF, Crossref.
- 4 CJ Currie, JR Peters, A Tynan, M Evans, RJ Heine, OL Bracco, et al. Survival as a function of HbA1c in people with type 2 diabetes: a retrospective cohort study. Lancet. 2010;375:481-489 Crossref.
- 5 R Qayyum, L Greene. AHRQ's comparative effectiveness research on premixed insulin analogues for adults with type 2 diabetes: understanding and applying the systematic review findings. J Manag Care Pharm. 2011;17(3):S3-19
- 6 American Diabetes Association. Standards of medical care in diabetes – 2012. Diabetes Care. 2012;35(1):S11-S63
- 7 A Vaag, SS Lund. Insulin initiation in patients with type 2 diabetes mellitus: treatment guidelines, clinical evidence and patterns of use of basal vs premixed insulin analogues. Eur J Endocrinol. 2012;166(2):159-170 Crossref.
- 8 A Dornhorst, HJ Lüddeke, S Sreenan, P Kozlovski, JB Hansen, BJ Looij, et al., PREDICTIVE Study Group. Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes: subgroup analysis from the PREDICTIVE study. Int J Clin Pract. 2008;62(4):659-665 Crossref.
- 9 SE Nelson. Detemir as once-daily basal insulin in type 2 diabetes. Clin Pharmacol. 2011;3:27-37 Crossref.
- 10 M John. Basal insulin analogues-a review of recent data on efficacy and safety. J Assoc Physicians India. 2011;59:25-28
- 11 A Philis-Tsimikas. An update on the use of insulin detemir, with a focus on type 2 diabetes (drug evaluation update). Expert Opin Pharmacother. 2008;9:2181-2195 Crossref.
- 12 P Soewondo, A Jain. Effect of insulin detemir (Levemir®) on risk of hypoglycaemia and glycaemic parameters: Experience from real life practice in Indonesian patients with diabetes mellitus. JAFES. 2012;26(1):51-55
- 13 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;88(1):S3-S9 Abstract, Full-text, PDF, Crossref.
- 14 P Soewondo, S Soegondo, K Suastika, A Pranoto, DW Soeatmadji, A Tjokroprawiro. The DiabCare Asia 2008 study – Outcomes on control and complications of type 2 diabetic patients in Indonesia. Med J Indones. 2010;19(4):235-244 Crossref.
- 15 Montañana C Fajardo, Herrero C Hernández, Fernández M Rivas. Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensification of insulin therapy in overweight type 2 diabetes patients: the PREDICTIVE BMI clinical trial. Diabet Med. 2008;25(8):916-923
- 16 A Philis-Tsimikas, G Charpentier, P Clauson, GM 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(10):1569-1581 Crossref.
- 17 L Blonde, M Merilainen, V Karwe, P Raskin, TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets – the TITRATE study. Diabetes Obes Metab. 2009;11(6):623-631 Crossref.
- 18 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(7258):405-412 Crossref.
- 19 A Dornhorst, HJ Lüddeke, M Honka, RW Ackermann, M Meriläinen, B Gallwitz, et al. Safety and efficacy of insulin detemir basal–bolus therapy in type 1 diabetes patients: 14-week data from the European cohort of the PREDICTIVE study. Curr Med Res Opin. 2008;24(2):369-376 Crossref.
- 20 J Rosenstock, M Davies, PD Home, J Larsen, C Koenen, G Schernthaner. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008;51(3):408-416 Crossref.
- 21 JE Sprague, AM Arbeláez. Glucose counterregulatory responses to hypoglycemia. Pediatr Endocrinol Rev. 2011;9(1):463-473
- 22 GK Panicker, DR Karnad, V Salvi, S Kothari. Cardiovascular risk of oral antidiabetic drugs: current evidence and regulatory requirements for new drugs. J Assoc Physicians India. 2012;60:56-61
- 23 RJ Ligthelm, M Kaiser, J Vora, JF Yale. Insulin use in elderly adults: risk of hypoglycemia and strategies for care. J Am Geriatr Soc. 2012;60(8):1564-1570 Crossref.
- 24 TM Chapman, CM Perry. Insulin detemir: a review of its use in the management of type 1 and 2 diabetes mellitus. Drugs. 2004;64(22):2577-2595 Crossref.
- 25 K Raslová, SC Tamer, P Clauson, D Karl. Insulin detemir results in less weight gain than NPH insulin when used in basal–bolus therapy for type 2 diabetes mellitus, and this advantage increases with baseline body mass index. Clin Drug Invest. 2007;27(4):279-285
- 26 RR Rubin, M Peyrot. Quality of life and diabetes. Diabetes Metab Res Rev. 1999;15(3):205-218 Crossref.
a University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia
b Fatmawati General Hospital, Jakarta, Indonesia Fatmawati General Hospital, Jakarta, Indonesia
c Gadjah Mada University, Sardjito Hospital, Yogyakarta, Indonesia Gadjah Mada University, Sardjito Hospital, Yogyakarta, Indonesia
d Sam Ratulangi University, Prof. Dr. R.D. Kandou Hospital, Manado, Indonesia Sam Ratulangi University, Prof. Dr. R.D. Kandou Hospital, Manado, Indonesia
e Diponegoro University, Kariadi Hospital, Semarang, Indonesia Diponegoro University, Kariadi Hospital, Semarang, Indonesia
Corresponding author at: Sp-PD-KEMO, Division of Endorinology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia. Tel.: +62 21 390 7703; fax: +62 21 392 8659
© 2013 Published by Elsevier B.V.