How pharmacokinetic and pharmacodynamic principles pave the way for optimal basal insulin therapy in type 2 diabetes

International Journal of Clinical Practice

Volumn 64, Issue 10, 2010, Pages 1415-1424

  Arnolds, S ^a   Kuglin, B ^a   Kapitza, C ^a   Heise, T ^a  

^a PROFIL Institut für Stoffwechselforschung   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN A1C; INSULIN DETEMIR; INSULIN GLARGINE; ISOPHANE INSULIN;

AREA UNDER THE CURVE; CONTINUING EDUCATION; GLUCOSE CLAMP TECHNIQUE; GLUCOSE INFUSION; HALF LIFE TIME; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; INSULIN TREATMENT; MEDICAL EDUCATION; NON INSULIN DEPENDENT DIABETES MELLITUS; PHARMACODYNAMICS; PHARMACOKINETICS; PRIORITY JOURNAL; REVIEW; TIME TO MAXIMUM PLASMA CONCENTRATION;

BLOOD GLUCOSE; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS, TYPE 2; GLUCOSE CLAMP TECHNIQUE; HALF-LIFE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; INSULIN, ISOPHANE; INSULIN, LONG-ACTING;

EID: 77955824820     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2010.02470.x     Document Type: Review

References (64)

1. Polonsky KS, Given BD, Van Cauter E. Twenty-four-hour profiles and pulsatile patterns of insulin secretion in normal and obese subjects. J Clin Invest 1988 81 : 442 8.
2. Owens DR, Bolli GB. Beyond the era of NPH insulin - long-acting insulin analogs: chemistry, comparative pharmacology, and clinical application. Diabetes Technol Ther 2008 10 : 333 49.
3. Berger M. Towards more physiological insulin therapy in the 1990s. Diabetes Res Clin Pract 1989 6 : S25 31.
4. White J, Campbell R. Diabetes mellitus. In : Herfindal ET, Gourley DR, eds. Textbook of Therapeutics: Drug and Disease Management.
5. Galloway JA, Chance RE. Improving insulin therapy: achievements and challenges. Horm Metab Res 1994 26 : 591 8.
6. Koschorreck M, Gilles ED. Mathematical modelling and analysis of insulin clearance in vivo. BMC Syst Biol 2008 2 : 43.
7. Tozer TN, Rowland M. Opening comments. In : Klingler A, ed. Introduction to Pharmacokinetics and Pharmacodynamics. The Quantitative Basis of Drug Therapy.
8. Heinemann L. Time-Action Profiles of Insulin Preparations.
9. Danne T, Lüpke K, Walte K, von Scheutz W, Gall M-A. Insulin detemir is characterized by a consistent pharmacokinetic profile across age-groups in children, adolescents, and adults with type 1 diabetes. Diabetes Care 2003 26 : 3087 92.
10. Bott S, Tusek C, Jacobsen LV et al. Insulin detemir under steady-state conditions: no accumulation and constant metabolic effect over time with twice daily administration in subjects with type 1 diabetes. Diabet Med 2006 23 : 522 8.
11. Owen WE, Roberts WL. Cross-reactivity of three recombinant insulin analogs with five commercial insulin immunoassays. Clin Chem 2004 50 : 257 9.
12. Committee for Proprietary Medicinal Products (CPMP). The European Agency for the Evaluation of Medicinal Products (EMEA). London [cited 21 October 2009]. http://www.emea.europa.eu/pdfs/human/ewp/108000en.pdf (accessed October 2009).
13. Heise T, Pieber TR. Towards peakless, reproducible and long-acting insulins. An assessment of the basal insulin analogues based on isoglycaemic clamp studies. Diabetes Obes Metab 2007 9 : 648 59.
14. Jehle PM, Micheler C, Jehle DR, Breitig D, Boehm BO. Inadequate suspension of neutral protamine Hagedorn (NPH) insulin in pens. Lancet 1999 354 : 1604 7.
15. Lepore M, Pampanelli S, Fanelli C et al. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and Ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes 2000 49 : 2142 8.
16. Sheldon B, Russell-Jones D, Wright J. Insulin analogues: an example of applied medical science. Diabetes Obes Metab 2009 11 : 5 19.
17. Home P, Kurtzhals P. Insulin detemir: from concept to clinical experience. Expert Opin Pharmacother 2006 7 : 325 43.
18. Luzio S, Dunseath G, Peter R, Pauvaday V, Owens DR. Comparison of the pharmacokinetics and pharmacodynamics of biphasic insulin aspart and insulin glargine in people with type 2 diabetes. Diabetologia 2006 49 : 1163 8.
19. Heise T, Nosek L, Biilmann Rønn 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.
20. Klein O, Lynge J, Endahl L, Damholt B, Nosek L, Heise T. Albumin-bound basal insulin analogues (insulin detemir and NN344): comparable time-action profiles but less variability than insulin glargine in type 2 diabetes. Diabetes Obes Metab 2007 9 : 290 9.
21. 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.
22. Porcellati F, Rossetti P, Busciantella NR et al. Comparison of pharmacokinetics and dynamics of the long-acting insulin analogs glargine and detemir at steady state in type 1 diabetes. A double-blind, randomized, crossover study. Diabetes Care 2007 30 : 2447 52.
23. Bock G, Wutte A, Köhler G, Korsatko S, Semlitsch B, Pieber TR. Pharmacodynamics and pharmacokinetics of long-acting insulin analogues detemir and glargine after 7 days of use and after its first administration in subjects with type 1 diabetes. Diabetologia 2008 51 (Suppl. 1 S390.
24. Rosenstock J, Dailey G, Massi-Benedetti M, Fritsche A, Lin Z, Salzman A. Reduced hypoglycaemia risk with insulin glargine. Diabetes Care 2005 28 : 950 5.
25. Bazzano LA, Lee LJ, Shi L, Reynolds K, Jackson JA, Fonseca V. Safety and efficacy of glargine compared with NPH insulin for the treatment of type 2 diabetes: a meta-analysis of randomized controlled trials. Diabet Med 2008 25 : 924 32.
26. Goykhman S, Drincic A, Desmangles JC, Rendell M. Insulin glargine: a review 8 years after its introduction. Expert Opin Pharmacother 2009 10 : 705 18.
27. Riddle MC, Rosenstock R, Gerich J, On behalf of the Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003 26 : 3080 6.
28. Yki-Järvinen H, Dressler A, Ziemen M, The HOE 9013002 Study Group. Less nocturnal hypoglycaemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. Diabetes Care 2000 23 : 1130 6.
29. Morales J. Defining the role of insulin detemir in basal insulin therapy. Drugs 2007 67 : 2557 84.
30. Philis-Tsimikas A. An update on the use of insulin detemir, with a focus on type 2 diabetes (drug evaluation update). Expert Opin Pharmacother 2008 9 : 2181 95.
31. Bartley PC, Bogoev M, Larsen J, Philotheou A. Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med 2008 25 : 442 9.
32. Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J. Effects of QD insulin detemir or Neutral Protamine Hagedorn on blood glucose control in patients with type 1 diabetes mellitus using a basal-bolus regimen. Clin Ther 2004 26 : 724 36.
33. Kølendorf K, Ross GP, Pavlic-Renar I et al. Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in type 1 diabetes. Diabet Med 2006 23 : 729 35.
34. Hermansen K, Davies M, Derezinski T et al. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naïve people with type 2 diabetes. Diabetes Care 2006 29 : 1269 74.
35. Philis-Tsimikas A, Charpentier G, Clauson P, Martinez Ravn G, Roberts VL, Thorsteinsson B. 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 81.
36. Vague P, Selam J-L, 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.
37. Standl E, Lang H, Roberts A. The 12-month efficacy and safety of insulin detemir and NPH insulin in basal-bolus therapy fort he treatment of type 1 diabetes. Diabetes Technol Ther 2004 6 : 579 88.
38. Haak T, Tiengo A, Draeger E, Suntum M, Waldhäusl 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 Obes Metab 2005 7 : 56 64.
39. Meneghini LF, Rosenberg KH, Koenen C, Merilainen MJ, Lüddeke H-J. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naïve or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab 2007 9 : 418 27.
40. 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.
41. 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.
42. Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall M-A. 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.
43. Heller S, Kim H, Draeger E. Within-person variation in fasting blood glucose is correlated to incidence of hypoglycaemia in people with type 1 diabetes treated with insulin detemir and NPH insulin [abstract]. Diabetologia 2004 47 (Suppl. 1 A303.
44. Gin H, Hanaire-Broutin H. Reproducibility and variability in the action of injected insulin. Diabetes Metab 2005 31 : 7 13.
45. Guerci B, Sauvanet JP. Subcutaneous insulin: pharmacokinetic variability and glycemic variability. Diabetes Metab 2005 31 : 4S7 24.
46. Pieber TR, Treichel H-C, Hompesch B et al. Comparison of insulin detemir and insulin glargine in subjects with type 1 diabetes using intensive insulin therapy. Diabet Med 2007 24 : 635 42.
47. Hollander P, Cooper J, Bregnhøj J, Bang Pedersen C. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-zarget trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther 2008 30 : 1976 87.
48. Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. 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 : 408 16.
49. King AB. Once-daily insulin detemir is comparable to once-daily insulin glargine in providing glycaemic control over 24 h in patients with type 2 diabetes: a double-blind, randomized, crossover study. Diabetes Obes Metab 2009 11 : 69 71.
50. Nathan DM, Buse JB, Davidson MB et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009 32 : 193 203.
51. Van Avendonk MJP, Rutten GEHM. Insulin therapy in type 2 diabetes: what is the evidence? Diabetes Obes Metab 2009 11 : 415 32.
52. Holman RR, Farmer AJ, Davies MJ et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med 2009 361 : 1736 47.
53. Roden M. Optimal insulin treatment in type 2 diabetes. N Engl J Med 2009 361 : 1801 3.
54. Holman RR, Thorne KI, Farmer AJ et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med 2007 357 : 1716 30.
55. Lasserson DS, Glasziou P, Perera R, Holman RR, Farmer AJ. Optimal insulin regimens in type 2 diabetes mellitus: systematic review and meta-analyses. Diabetologia 2009 52 : 1990 2000.
56. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA1c. Diabetes Care 2003 26 : 881 5.
57. Barnett A. Dosing of insulin glargine in the treatment of type 2 diabetes. Clin Ther 2007 29 : 987 99.
58. Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R, ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care 2005 28 : 1282 8.
59. Yki-Järvinen H, Kauppinen-Mäkelin R, Tiikkainen M et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia 2006 49 : 442 51.
60. TM 303 study. Diabetes Obes Metab 2007 9 : 902 13.
61. TM study. Diabetes Obes Metab 2009 11 : 623 31.
62. Tibaldi J, Rakel RE. Why, when and how to initiate insulin therapy in patients with type 2 diabetes. Int J Clin Pract 2007 61 : 633 44.
63. Kunt T, Snoek FJ. Barriers to insulin initiation and intensification and how to overcome them. Int J Clin Pract 2009 63 (Suppl. 164 6 10.
64. Rave KM, Nosek L, de la Peña A et al. Dose response of inhaled dry-powder insulin and dose equivalence to subcutaneous insulin lispro. Diabetes Care 2005 28 : 2400 5.