Iowa medicaid 2: lapse of glycemic control on abrupt transition from insulin glargine to insulin detemir in type 2 diabetes mellitus — Oak Academic Publishing
Research ArticleOpen AccessGoogle Scholar indexed
Iowa medicaid 2: lapse of glycemic control on abrupt transition from insulin glargine to insulin detemir in type 2 diabetes mellitus
Background: Iowa Care (Iowa Medicaid in State of Iowa, USA), switched insulin glargine to detemir in subjects with Diabetes Mellitus (DM) without the knowledge or approval of healthcare providers beginning 8/2006.Impact of this transition in subjects with Type 1 DM is recently reported. Objective: To examine the impact of this transition on various parameters of diabetes management in Type 2 DM. Subjects and Methods: A retrospective review of the records of subjects with Type 2 DM was conducted until 8/2007 in whom the transition had occurred. Only those subjects with adequate glycemic control while receiving insulin glargine [GI] and completing at least 3 months of therapy with insulin detemir [DI] are included in this report. Ten subjects with Type 2 DM, duration 7 ± 2 years with age, 55 ± 3 years who were switched from GI to DI (Group 1) fulfilled the criteria for inclusion. Subjects were switched from GI in Q AM to DI Q HS in the same daily dose. Glycemic control (HbA1c), body weight, daily insulin dose (Units) and severe hypoglycemic events during the last 2 weeks of the period, pre switch and again at the end of 3 months post switch were assessed. Records of 8 subjects matched for age, duration of DM, glycemic control while receiving GI for additional 3 months (Group 2) during the same period were examined for comparison. All subjects were followed in the outpatient clinic at intervals of 3 months. Results Glycemic control remained stable on continuing GI AM; HbA1c; 7.1 ± 0.3 to 7.1 ± 0.3%, while it worsened on switching to DI Q HS; HbA1c, 7.1 ± 0.3 to 8.1 ± 0.5 [P < 0.01]. A mild weight loss was noted in subjects on transition. No severe hypoglycemic events were reported in any subject in either group. Conclusion Abrupt transition from insulin glargine to insulin detemir in subjects with Type 2 DM is likely to result in lapse of glycemic control which may cause decreased quality of life. Furthermore, use of insulin detemir may result in increased costs due to need of the higher daily dose as well as additional equipment required for probable twice daily administration to achieve adequate glycemic control. Therefore, insulin glargine and detemir appear to be far from being bioequivalent.
KeywordsType 2 DiabetesInsulin GlargineInsulin DetemirGlycemic Control
Kabadi, U.M. (2008) Deleterious outcomes after abrupt transition from insulin glargine to insulin detemir in patients with type 1 diabetes mellitus. Clinical Drug Investigation, 28, 697-701. doi:10.2165/00044011-200828110-00003
American Diabetes Association (2011) Standards of medical care in diabetes-2011. Diabetes Care, 34, S11-S61.
Fritsche, A., Schweitzer, M.A. and Haring, H.U. (2003) Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Annals of Internal Medicine, 138, 952-959.
Schreiber, S.A., Ferlinz, K. and Haak, T. (2008) The long-term efficacy of insulin glargine plus oral antidiabetic agents in a 32-month observational study of everyday clinical practice. Diabetes Technology & Therapeutics, 10, 121-127. doi:10.1089/dia.2007.0265
Hammer, H. and Klinge, A. (2007) Patients with type 2 diabetes inadequately controlled on premixed insulin: Effect of initiating insulin glargine plus oral antidiabetic agents on glycemic control in daily practice. International Journal of Clinical Practice, 61, 2009-2018. doi:10.1111/j.1742-1241.2007.01598.x
Standl, E., Maxeiner, S., Raptis, S., Karimi-Anderesi, Z. and Schweitzer, M.A. (2005) Good glycemic control with flexibility in timing of basal insulin supply: A 24-week comparison of insulin glargine given once daily in the morning or at bedtime in combination with morning glimepiride. Diabetes Care, 28, 419-420. doi:10.2337/diacare.28.2.419
Wang, Z.H., Hedrington, M.S., Joy, N.G., Briscoe, V.J., Richardson, M.A., Younk, L., Nicholson, W., Tate, D.B. and Davis, S.N. (2010) Dose-response effects of insulin glargine in type 2 diabetes. Diabetes Care, 33, 1555-1560. doi:10.2337/dc09-2011
Swinnen, S.G. and De Vries, J.H. (2009) Higher dose requirements with insulin detemir in type 2 diabetes— Three cases and a review of the literature. Diabetes Research and Clinical Practice, 84, 24-26. doi:10.1016/j.diabres.2009.02.009
Bott, S., Tusek, C., Jacobsen, L.V., et al. (2006) Insulin detemir under steady-state conditions: No accumulation and constant metabolic effect over time with twice daily administration in subjects with type 1 diabetes. Diabetic Medicine, 23, 522-528.
Pieber, T.R., Treichel, H.C., Hompesch, B., et al. (2007) Comparison of insulin detemir and insulin glargine in subjects with type 1 diabetes using intensive insulin therapy. Diabetic Medicine, 24, 635-642. doi:10.1111/j.1464-5491.2007.02113.x
Dornhorst, A., Luddeke, H.J., Sreenan, S., et al. (2007) 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. International Journal of Clinical Practice, 61, 523-528. doi:10.1111/j.1742-1241.2007.01316.x
Rosenstock, J., Davies, M., Home, P.D., Larsen, J., Koe- nen, C. and Schernthaner, G. (2008) A randomized, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-owering drugs in insulin-naive people with type 2 diabetes. Diabetologia, 51, 408-416. doi:10.1007/s00125-007-0911-x
Hollander, P., Cooper, J., Bregnhoj, J. and Pedersen, C.B. (2008) A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clinical Therapeutics, 30, 1976-1987.
Raskin, P., Gylvin, T., Weng, W. and Chaykin, L. (2009) Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes. Diabetes/Metabolism Research and Reviews, 25, 542-548. doi:10.1002/dmrr.989
Johnson, C.K. and Shimshi, M. (2009) When a unit of insulin is not a unit: Detemir dosing and insulin cost in type 2 diabetes mellitus. Insulin, 4, 87-93. doi:10.1016/S1557-0843(09)80017-1
Swinnen, S.G., Dain, M.P., Aronson, R., Davies, M., Gerstein, H.C., Pfeiffer, A.F., Snoek, F.J., Devries, J.H., Hoekstra, J.B. and Holleman, F.A. (2010) 24-week, randomized, treat-to-target trial comparing initiation of insulin glargine once-daily with insulin detemir twice-daily in patients with type 2 diabetes inadequately controlled on oral glucose-lowering drugs. Diabetes Care, 33, 1176-1178. doi:10.2337/dc09-2294
Dailey, G., Admane, K., Mercier, F. and Owens, D. (2010) Relationship of insulin dose, A1c lowering, and weight in type 2 diabetes: Comparing insulin glargine and insulin detemir. Diabetes Technology & Therapeutics, 12, 1019-1027. doi:10.1089/dia.2010.0063
Kato, T., Tokubuchi, I., Muraishi, K., Sato, S., Kato, T., Hara, K., Tanaka, K., Kaku, H., Tajiri, Y. and Yamada, K. (2010) Distinct pharmacodynamics of insulin glargine and insulin detemir: Crossover comparison in type 1 and type 2 diabetic patients on basal-bolus regimen. Diabetes Research and Clinical Practice, 90, 64-66. doi:10.1016/j.diabres.2010.08.011
Lucidi, P., Porcellati, F., Rossetti, P., Candeloro, P., Cioli, P., Marzotti, S., Andreoli, A.M., Fede, R., Bolli, G.B. and Fanelli, C.G. (2011) Pharmacokinetics and pharmacodynamics of therapeutic doses of basal insulins NPH, glargine, and detemir after 1 week of daily administration at bedtime in type 2 diabetic subjects: A randomized cross-over study. Diabetes Care, 34, 1312-1314. doi:10.2337/dc10-1911
Malone, J.K., Kerr, L.F., Campaigne, B.N., Sachson, R.A. and Holcombe, J.H. (2004) Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargineplus metformin: A 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clinical Therapeutics, 26, 2034-2044. doi:10.1016/j.clinthera.2004.12.015
Kabadi, M.U. and Kabadi, U.M. (2003) Efficacy of sulfonylureas with insulin in type 2 diabetes mellitus. The Annals of Pharmacotherapy, 37, 1572-1576, doi:10.1345/aph.1C492
Janka, H.U., Plewe, G., Riddle, M.C., Kliebe-Frisch, C., Schweitzer, M.A. and Yki-Jarvinen, H. (2005) Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care, 28, 254-259. doi:10.2337/diacare.28.2.254
Raskin, P., Allen, E., Hollander, P., Lewin, A., Gabbay, R.A., Hu, P., Bode, B. and Garber, A. (2005) Initiating insulin therapy in type 2 diabetes: A comparison of biphasic and basal insulin analogs. Diabetes Care, 28, 260-265.
Kabadi, U.M. (2006) Comparative efficacy of glimepiride and/or metformin with insulin in type 2 diabetes. Diabetes Research & Clinical Practice, 72, 265-270. doi:10.1016/j.diabres.2005.10.024
Ligthelm, R.J., Gylvin, T., DeLuzio, T. and Raskin, P.A. (2011) Comparison of twice-daily biphasic insulin aspart 70/30 and once-daily insulin glargine in persons with type 2 diabetes mellitus inadequately controlled on basal insulin and oral therapy: A randomized, open-label study. Endocrine Practice, 17, 41-50. doi:10.4158/EP10079.OR
Pscherer, S., Dietrich, E.S., Dippel, F.W. and Neilson, A.R. (2010) Comparison of one-year costs of type 2 diabetes treatment with insulin glargine or insulin detemir in a basal supported oral therapy (BOT) in Germany. International Journal of Clinical Pharmacology and Therapeutics, 48, 129-137.
Bierwirth, R.A., Kohlmann, T., Moock, J., Holle, R. and Landgraf, W. (2010) Costs of diabetes care and treatment satisfaction in type 2 diabetes patients treated with a basal-bolus (ICT) insulin regimen in outpatient care: Results of the LIVE-COM study. Medizinische Klinik (Munich), 105, 792-801. doi:10.1007/s00063-010-1136-1
Gilmer, T.P., O’Conner, P.J., Manning, W.G., et al. (1997) The cost to health plans of poor glycemic control. Diabetes Care, 20, 1847-1853. doi:10.2337/diacare.20.12.1847
Gray, A., Raikoi, M., McGuire, A., et al. (2000) Cost effectiveness of an intensive blood glucose control policy in patients with type 2 diabetes; economic analysis alongside randomized controlled trial (UKPDS 41). British Medical Journal, 320, 1373-1378. doi:10.1136/bmj.320.7246.1373
Testa, M.A. and Simonson, D.C. (1998) Health economic benefits and quality of life during improved glycemic control in patients with type 2 diabetes mellitus: A randomized, controlled, double-blind trial. The Journal of the American Medical Association, 208, 1490-1496. doi:10.1001/jama.280.17.1490
Adler, A.I., Stratton, I.M., Neil, H.A.W., et al. (2000) Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): Prospective observational study. British Medical Journal, 321, 412-419. doi:10.1136/bmj.321.7258.412
Skyler, J.S. (1996) Diabetic complications. The importance of glucose control. Endocrinology Metabolism Clinics of North America, 252, 243-254.
DCCT Research Group (1993) The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The New England Journal of Medicine, 329, 977-986. doi:10.1056/NEJM199309303291401
Ohkubo, Y., Kishikawa, H., Araki, E., et al. (1995) Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: A randomized prospective 6-year study. Diabetes Research and Clinical Practice, 28, 103-117. doi:10.1016/0168-8227(95)01064-K
United Kingdom Prospective Diabetes Study (UKPDS) (1998) Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). The Lancet, 353, 837-853.