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Original Article

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

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Pages 369-376 | Accepted 11 Jan 2008, Published online: 19 Dec 2007

References

  • American Diabetes Association. Standards of medical care in diabetes – 2006. Diabetes Care 2006;29 (Suppl 1):S4–42
  • American Association of Clinical Endocrinologists. Medical guidelines for the management of diabetes mellitus: the AACE system of intensive diabetes self-management – 2002 update. Endocr Pract 2002;8(Suppl 1):43–84
  • Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–86
  • Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care 2003;26:1902–12
  • Davis S, Alonso MD. Hypoglycemia as a barrier to glycemic control. J Diabetes Comp 2004;18:60–8
  • Carlson MG, Campbell PJ. Intensive insulin therapy and weight gain in IDDM. Diabetes 1993;42:1700–7
  • Davies M. The reality of glycaemic control in insulin treated diabetes: defining the clinical challenges. Int J Obes Relat Metab Disord 2004;28(Suppl 2):S14–22
  • New J, Hollis S, Campbell F, et al. Measuring clinical performance and outcomes from diabetes information systems: an observational study. Diabetologia 2000;43:836–43
  • Duckworth WC. Hyperglycemia and cardiovascular disease. Curr Atheroscler Rep 2001;3:383–91
  • Writing team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group.Effectofintensive therapy on themicrovascular complications of type 1 diabetes mellitus. JAMA 2002;287: 2563–9
  • Writing team for the Diabetes Control and Complications Trial/ Epidemiology of Diabetes Interventions and Complications Research Group. Sustained effect of intensive treatment of type 1 diabetes mellitus on development and progression of diabetic nephropathy: the Epidemiology of Diabetes Interventions and Complications (EDIC) study. JAMA 2003;290: 2159–67
  • Nathan DM, Cleary PA, Backlund JY, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;353:2643–53
  • Reichard P, Nilsson BY, Rosenqvist U. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N Engl J Med 1993;329:304–9
  • Home PD, Barriocanal L, Lindholm A. Comparative pharmacokinetics and pharmacodynamics of the novel rapid-acting insulin analogue, insulin aspart, in healthy volunteers. Eur J Clin Pharmacol 1999;55:199–203
  • Mudaliar SR, Lindberg FA, Joyce M, et al. Insulin aspart (B28 asp-insulin): a fast-acting analog of human insulin: absorption kinetics and action profile compared with regular human insulin in healthy nondiabetic subjects. Diabetes Care 1999;22:1501–6
  • Heinemann L, Linkeschova R, Rave K, Hompesch B, et al. Time-action profile of the long-acting insulin analog insulin glargine (HOE901) in comparison with those of NPH insulin and placebo. Diabetes Care 2000;23:644–9
  • Plank J, Bodenlenz M, Sinner F, et al. A double-blind, randomized, dose-response study investigating the pharmacodynamic and pharmacokinetic properties of the long-acting insulin analog detemir. Diabetes Care 2005;28:1107–12
  • Milicevic Z, Profozic V, Wyatt J, et al. Intramuscular injection of insulin lispro or soluble human insulin: pharmacokinetics and glucodynamics in type 2 diabetes. Diabet Med 2001;18: 562–6
  • Plank J, Wutte A, Brunner G, et al. A direct comparison of insulin aspart and insulin lispro in patients with type 1 diabetes. Diabetes Care 2002;25:2053–7
  • Osterberg O, Erichsen L, Ingwersen SH, et al. Pharmacokinetic and pharmacodynamic properties of insulin aspart and human insulin. J Pharmacokinet Pharmacodynam 2003;30:221–35
  • Becker RH, Frick AD, Burger F, et al. Insulin glulisine, a new rapid-acting insulin analogue, displays a rapid time-action profile in obese non-diabetic subjects. Exp Clin Endocrinol Diabetes 2005;113:435–43
  • Hirsch IB. Insulin analogues. N Engl J Med 2005;352:174–83
  • Hermansen K, Fontaine P, Kukolja KK, et al. 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;47:622–9
  • Home P, Bartley P, Russell-Jones D, et al. Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial. Diabetes Care. 2004;27: 1081–7
  • Pieber TR, Draeger E, Kristensen A, Grill V. Comparison of three multiple injection regimens for type 1 diabetes: morning plus dinner or bedtime administration of insulin detemir vs. morning plus bedtime NPH insulin. Diabet Med 2005;22:850–7
  • Heise T, Nosek L, Ronn B, et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes. 2004;53:1614–20
  • Vague P, Selam JL, Skeie S, et al. Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart. Diabetes Care 2003;26:590–6
  • Russell-Jones D, Simpson R, Hylleberg B, et al. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther 2004;26:724–36
  • Standl E, Lang H, Roberts A. The 12-month efficacy and safety of insulin detemir and NPH insulin in basal-bolus therapy for the treatment of type 1 diabetes. Diabetes Technol Ther 2004;6: 579–88
  • Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies and the hierarchy of research designs. N Engl J Med 2000;342:1887–92
  • Pocock SJ, Elbourne DR. Randomized trials or observational tribulations? N Engl J Med 2000;342:1907–9
  • Vandenbroucke JP. What is the best evidence for determining harms of medical treatment? CMAJ 2006;174:645–6
  • European Agency for the Evaluation of Medicinal Products. Pharmacovigilance -Medicinal Products for Human Use. EMEA 2004:34–5
  • Lüddeke H-J, Sreenan S, Aczel S, et al. PREDICTIVE™: A global, prospective observational study to evaluate insulin detemir treatment in type 1 and type 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort. Diabetes Obes Metab 2007;9: 428–34
  • Dornhorst A Lüddeke H-J, Sreenan S, 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 2007:61:523–8

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