Effect of Insulin Detemir (Levemir®) on Risk of Hypoglycaemia and Glycaemic Parameters: Experience from Real Life Practice in Indonesian Patients with Diabetes Mellitus

Pradana Soewondo; Anand Jain

doi:10.15605/jafes.026.01.10

Authors

Pradana Soewondo Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Anand Jain Novo Nordisk Pharma Operations (BAOS) Sdn Bhd, Kuala Lumpur, Malaysia

DOI:

https://doi.org/10.15605/jafes.026.01.10

Keywords:

insulin detemir, Indonesia, safety, efficacy

Abstract

Objective. To evaluate the safety and efficacy of insulin detemir in patients with diabetes mellitus in Indonesia.

Methods. This was a multi-centre, prospective, 12-week observational study in patients with diabetes mellitus conducted in Indonesia.

Results. A non-randomized sample of 1290 patients with diabetes mellitus in which most of them were type 2 diabetes (1285 patients, 57.4% males, mean age 54.1 ± 9.0 years, mean BMI 23.5 ± 4.1 kg/m², mean duration of diabetes 6.5 ± 4.9 years) were recruited from 121 sites. No serious adverse drug reactions (SADRs) including major hypoglycaemic episodes were reported at 12 weeks. The rate of total and major hypoglycaemic episodes decreased from 0.0248 to 0.0031 episodes/patient years and from 0.0022 to 0 episodes/patient years from baseline to 12 weeks, respectively. Treatment with insulin detemir was associated with a reduction in HbA_1c of ‑2.0%-point (95% CI, ‑2.13 to ‑1.93) from baseline to 12 weeks. Insulin detemir also improved FPG. A slight increase of 0.12 kg (95% CI, ‑0.05 to 0.29) in body weight was observed from baseline to 12 weeks.

Conclusions. 12-week treatment with insulin detemir was safe and well-tolerated in Indonesian patients with type 2 diabetes. It improved glycaemic control, decreased the risk of hypoglycaemia and was relatively weight neutral.

Downloads

Download data is not yet available.

References

Diabetes Control and Complications Trial (DCCT) Research Group. Effect of Intensive Diabetes Treatment on the Development and Progression of Long-Term Complications in Adolescents with Insulin-Dependent Diabetes-Mellitus - Diabetes Control and Complications Trial. Journal of Pediatrics 1994; 125(2): 177-188.

Turner RC, Holman RR, Cull CA, Stratton IM, Matthews DR, Frighi V et al. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352(9131): 837-853.

Malmberg K. Prospective randomised study of intensive insulin treatment on long term survival after acute myocardial infarction in patients with diabetes mellitus. DIGAMI (Diabetes Mellitus, Insulin Glucose Infusion in Acute Myocardial Infarction) Study Group. BMJ 1997; 314(7093): 1512-1515.

Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 359(15): 1577-1589.

Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005; 353(25): 2643-2653.

Hermansen K, Madsbad S, Perrild H, Kristensen A, Axelsen M. Comparison of the soluble basal insulin analog insulin detemir with NPH insulin - A randomized open crossover trial in type 1 diabetic subjects on basal-bolus therapy. Diabetes Care 2001; 24(2): 296-301.

Haak T, Tiengo A, Draeger E, Suntum M, Waldhausl W. Lower within-subject variability of fasting blood glucose and reduced weight gain with insulin detemir compared to NPH insulin in patients with type 2 diabetes. Diabetes Obesity & Metabolism 2005; 7(1): 56-64.

Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia 2004; 47(4): 622-629.

Raslova K, Bogoev M, Raz I, Leth G, Gall MA, Hancu N. Insulin detemir and insulin aspart: A promising basal-bolus regimen for type 2 diabetes. Diabetes Res Clin Pract 2004; 66(2): 193-201.

Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004; 27(5): 1047-1053.

Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J et al. Prevalence of diabetes among men and women in China. N Engl J Med 2010; 362(12): 1090-1101.

Mihardja L, Delima, Manz HS, Ghani L, Soegondo S. Prevalence and determinants of diabetes mellitus and impaired glucose tolerance in Indonesia (a part of basic health research/riskesdas). Acta Med Indones 2009; 41(4): 169-174.

World Medical Association. World Medical Association declaration of Helsinki - Ethical principles for medical research involving human subjects. JAMA 2000; 284(23): 3043-3045.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) adopts Consolidated Guideline on Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use Int Dig Health Legis 1997; 48(2): 231-234.

Dornhorst A, Luddeke HJ, Honka M, Ackermann RW, Merilainen M, Gallwitz B 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.

Dornhorst A, Luddeke HJ, Sreenan S, Kozlovski P, Hansen JB, Looij BJ et al. Insulin detemir improves glycaemic control without weight gain in insulin-naive patients with type 2 diabetes: subgroup analysis from the PREDICTIVE study. Int J Clin Pract 2008; 62(4): 659-665.

Dornhorst A, Luddeke HJ, Koenen C, Merilainen M, King A, Robinson A et al. Transferring to insulin detemir from NPH insulin or insulin glargine in type 2 diabetes patients on basal-only therapy with oral antidiabetic drugs improves glycaemic control and reduces weight gain and risk of hypoglycaemia: 14-week follow-up data from PREDICTIVE. Diabetes Obes Metab 2008; 10(1): 75-81.

Meneghini LF, Rosenberg KH, Koenen C, Merilainen MJ, Luddeke HJ. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab 2007; 9(3): 418-427.

Fritsche A, Haring H. At last, a weight neutral insulin? Int J Obes Relat Metab Disord 2004; 28 Suppl 2: S41-S46.

Hennige AM, Sartorius T, Tschritter O, Preissl H, Fritsche A, Ruth P et al. Tissue selectivity of insulin detemir action in vivo. Diabetologia 2006; 49(6): 1274-1282.

Valensi P, Cosson E. Is insulin detemir able to favor a lower variability in the action of injected insulin in diabetic subjects? Diabetes Metab 2005; 31(4 Pt 2): 4S34-4S39.