Pharmacokinetics and Pharmacodynamics of Basal Insulins

Diabetes Technology and Therapeutics

Volumn 13, Issue , 2011, Pages S-15-S-24

  Porcellati, Francesca ^a   Bolli, Geremia B ^a   Fanelli, Carmine G ^a  

^a UNIVERSITY OF PERUGIA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; BASAL INSULIN; DRUG DERIVATIVE; INSULIN;

COMPARATIVE STUDY; GLUCOSE CLAMP TECHNIQUE; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; METABOLISM; METHODOLOGY; NON INSULIN DEPENDENT DIABETES MELLITUS; REVIEW; STANDARD;

DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; GLUCOSE CLAMP TECHNIQUE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN;

EID: 80054084342     PISSN: 15209156     EISSN: 15578593     Source Type: Journal    
DOI: 10.1089/dia.2011.0038     Document Type: Article

References (48)

1. Kruszynska YT: Normal metabolism: the physiology of fuel homeostatis. In: Pickup J, Williams G, eds. Textbook of Diabetes. Oxford: Blackwell Science, 2003:9.1-9.38.
2. Owens D.R., Zinman B, Bolli GB: Insulins today and beyond. Lancet 2001;358:739-746.
3. Rossetti P, Porcellati F, Fanelli C.G., Perriello G, Torlone E, Bolli GB: Superiority of insulin analogs versus human insulin in the treatment of diabetes mellitus. Arch Physiol Biochem 2008;114:3-10.
4. Heinemann L, Linkeschova R, Rave K, Hompesch B, Sedlak M, Heise T: Time-action profile of the long-acting insulin analog insulin glargine (HOE901) in comparison with those of NPH insulin and placebo. Diabetes Care 2000;23:644-649.
5. Fanelli G.C., Pampanelli S, Porcellati F, Rossetti P, Brunetti P, Bolli GB: Administration of neutral protamine Hagedorn insulin at bedtime versus dinner in type 1 diabetes mellitus to avoid nocturnal hypoglycemia and improve control. A randomized, controlled trial. Ann Intern Med 2002;136:504-514.
6. Binder C, Lauritzen T, Faber O, Pramming S: Insulin pharmacokinetics. Diabetes Care 1984;7:188-199.
7. Jehle P.M., Micheler C, Jehle D.R., Breitig D, Boehm BO: Inadequate suspension of neutral protamine Hagendorn (NPH) insulin in pens. Lancet 1999;354:1604-1607.
8. Owens D.R., Bolli GB: Beyond the era of NPH insulinâlong-acting insulin analogs: chemistry, comparative pharmacology, and clinical application. Diabetes Technol Ther 2008;10:333-349.
9. Heinemann L, Anderson JH Jr: Measurement of insulin absorption and insulin action. Diabetes Technol Ther 2004;6:698-718.
10. DeFronzo R.A., Tobin J.D., Andres R: Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol 1979;237:E214-E223.
11. Gerritzen F: The classification of various insulins. Br Med J 1953;2:1030-1031.
12. Brunner G.A., Sendhofer G, Wutte A, Ellmerer M, Sãgaard B, Siebenhofer A, Hirschberger S, Krejs G.J., Pieber TR: Pharmacokinetic and pharmacodynamic properties of long-acting insulin analog NN304 in comparison to NPH insulin in humans. Exp Clin Endocrinol Diabetes 2000;108:100-105.
13. Heinemann L, Kapitza C, Starke A.A., Heise T: Time-action profile of the insulin analogue B28Asp. Diabet Med 1996;7:683-684.
14. Heinemann L, Sinha K, Weyer C, Loftager M, Hirschberger S, Heise T: Time-action profile of the soluble, fatty acid acylated, long-acting insulin analog NN304. Diabet Med 1999;16:332-338.
15. Swinnen SGHA, Holleman F, DeVries JH: The interpretation of glucose clamp studies of long-acting insulin analogues: from physiology to marketing and back. Diabetologia 2008;51:1790-1795.
16. Heinemann L, Heise T, Wahl L.C., Trautmann M.E., Ampudia J, Starke A.A., Berger M: Prandial glycaemia after a carbohydrate-rich meal in type I diabetic patients: using the rapid acting insulin analogue [Lys(B28), Pro(B29)] human insulin. Diabet Med 1996;7:625-629.
17. Linn T, Fischer B, Soydan N, Eckhard M, Ehl J, Kunz C, Bretzel RG: Nocturnal glucose metabolism after bedtime injection of insulin glargine or NPH insulin in patients with type 2 diabetes. J Clin Endocrinol Metab 2008;93:3839-3846.
18. Sãrensen L.P., Brock B, Mengel A, Rungby J, Moller N, Nielsen S, Vãlund A, Schmitz O: Similarity of pharmacodynamic effects of a single injection of insulin glargine, insulin detemir and NPH insulin on glucose metabolism assessed by 24-h euglycaemic clamp studies in healthy humans. Diabet Med 2010;27:830-837.
19. 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;9:648-659.
20. Senn S: Cross-Over Trials in Clinical Research, 2nd ed. New York: John Wiley & Sons, 2002:98-125.
21. De Feo P, Perriello G, Ventura M.M., Calcinaro F, Basta G, Lolli C, Cruciani C, Dell'Olio A, Santeusanio F, Brunetti P, Bolli GB: Studies on overnight insulin requirements and metabolic clearance rate of insulin in normal and diabetic man: relevance to the pathogenesis of the dawn phenomenon. Diabetologia 1986;29:475-480.
22. Heise T, Nosek L, Rãnn B.B., Endahl L, Heinemann L, Kapitza C, Draeger E: Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes 2004;53:1614-1620.
23. Lepore M, Pampanelli S, Fanelli C, Porcellati F, Bartocci L, Di Vincenzo A, Cordoni C, Costa E, Brunetti P, Bolli GB: 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;49:2142-2148.
24. Porcellati F, Rossetti P, Busciantella S, Marzotti S, Lucidi P, Luzio S, Owens D.R., Bolli G.B., Fanelli CG: Comparison of pharmacokinetics and -dynamics of the long-acting insulin analogs glargine and detemir at steady state in type 1 diabetes mellitus: a double-blind, randomized, cross-over study. Diabetes Care 2007;30:2447-2452.
25. Porcellati F, Rossetti P, Busciantella Ricci N, Pampanelli S, Torlone E, Hernadez Campos S, Marinelli Andreoli A, Bolli G.B., Fanelli CG: Pharmacokinetics and pharmacodynamics of the long-acting insulin analog glargine after one week of use as compared to its first administration in subjects with Type 1 diabetes mellitus. Diabetes Care 2007;30:1261-1263.
26. Bock G, Wutte A, Kãhler 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 [abstract]. Diabetologia 2008;51(Suppl 1):S390.
27. Lucidi P, Porcellati F, Rossetti P, Candeloro P, Cioli P, Marzotti S, Marinelli Andreoli A, Fede R, Bolli G.B., Fanelli CG: Pharmacokinetics and pharmacodynamics of therapeutic doses of basal insulins NPH, glargine, and detemir after 1 week of daily administration at bedtime in type 2 diabetes: a randomized cross-over study. Diabetes Care 2011 April 15 [Epub ahead of print]. doi: 10.2337/dc10-1911.
28. Hompesch M, Ocheltree S.M., Wondmagegnehu E.T., Morrow L.A., Kollmeier A.P., Campaigne B.N., Jacober SJ: Pharmacokinetics and pharmacodynamics of insulin lispro protamine suspension compared with insulin glargine and insulin detemir in type 2 diabetes. Curr Med Res Opin 2009;11:2679-2687.
29. Plank J, Bodenlenz M, Sinner F, Magnes C, Gãrzer E, Regittnig W, Endahl L.A., Draeger E, Zdravkovic M, Pieber TR: A double-blind, randomized, dose-response study investigating the pharmacodynamic and pharmacokinetic properties of the long-acting insulin analog detemir. Diabetes Care 2005;28:1107-1112.
30. Klein O, Lynge J, Endahl L, Damholt B, Nosek L, Heise T: Albumin-bound basal insulin analogs (insulin detemir and NN344): comparable time-action profiles but less variability than insulin glargine in type 2 diabetes. Diabetes Obes Metab 2007;9:290-299.
31. Wutte A, Plank J, Bodenlenz M, Magnes C, Regittnig W, Sinner F, Rãnn B, Zdravkovic M, Pieber TR: Proportional dose-response relationship and lower within-patient variability of insulin detemir and NPH insulin in subjects with type 1 diabetes mellitus. Exp Clin Endocrinol Diabetes 2007;115:461-467.
32. 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;49:1163-1168.
33. Heise T, Hermanski L, Nosek L, Feldmann A, Rasmussen S, Stryhn T.K., Haarh H: Insulin degludec: less pharmacodynamic variability than insulin glargine under steady state conditions [abstract]. Diabetologia 2010;53(Suppl 1):S387.
34. Bolli GB Gerich JE: The dawn phenomenon: a common occurrence in both non-insulin-dependent and insulin-dependent diabetes mellitus. N Engl J Med 1984;310:746-750.
35. Scholtz H.E., Pretorius S.G., Wessels D.H., Becker RH: Pharmacokinetic and glucodynamic variability: assessment of insulin glargine, NPH insulin and insulin ultralente in healthy volunteers using a euglycemic clamp technique. Diabetologia 2005;48:1988-1995.
36. Heise T, Bott S, Rave K, Dressler A, Rosskamp R, Heinemann L: No evidence for accumulation of insulin glargine (LANTUS): a multiple injection study in patients with Type 1 diabetes. Diabet Med 2002;19:490-495.
37. Hompesch M, Troupin B, Heise T, Elbroend B, Endahl L, Haahr H, Heinemann L: Time-action profile of insulin detemir and NPH insulin in patients with type 2 diabetes from different ethnic groups. Diabetes Obes Metab 2006;8:568-573.
38. European Medicines Agency, Committee for Proprietary Medicinal Products: Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Diabetes Mellitus. 2002. www.emea.europa.eu/pdfs/human/ewp/108000en.pdf (accessed April 19, 2011).
39. DeVries JH. To: Scholtz H.E., Pretorius S.G., Wessels D.H., Becker RHA (2005) Pharmacokinetic and glucodynamic variability: assessment of insulin glargine, NPH insulin and insulin ultralente in healthy volunteers using a euglycaemic clamp technique Diabetologia 2006;49:1125-1126.
40. Kurtzhals P, Schãffer L, Sãrensen A, Kristensen C, Jonassen I, Schmid C, Trüb T: Correlations of receptor binding and metabolic and mitogenic potencies of insulin analogs designed for clinical use. Diabetes 2000;49:999-1005.
41. Hordern S.V., Wright J.E., Umpleby A.M., Shojaee-Moradie F, Amiss J, Russell-Jones DL: Comparison of the effects on glucose and lipid metabolism of equipotent doses of insulin detemir and NPH insulin with a 16-h euglycemic clamp. Diabetologia 2005;48:420-426.
42. Owens D.R., Coates P.A., Luzio S.D., Tinbergen J.P., Kurzhals R: Pharmacokinetics of 125I-labeled insulin glargine (HOE 901) in healthy men: comparison with NPH insulin and the influence of different subcutaneous injection sites. Diabetes Care 2000;23:813-819.
43. Wang Z, Hedrington MS,Gogitidze Joy N, Briscoe V.J., Richardson M.A., Younk L, Nicholson W, Tate D.B., Davis SN: Dose response effects of insulin glargine in type 2 diabetes. Diabetes Care 2010;33:1555-1560.
44. Porcellati F, Lucidi P, Rossetti P, Candeloro P, Marinelli Andreoli A, Cioli P, Bolli G.B., Fanelli CG: Pharmacodynamics of basal insulins NPH, glargine and detemir in type 2 diabetes mellitus: effects of adiposity [abstract]. Diabetes 2011;60(Suppl 1) (in press).
45. Bruttomesso D, Crazzolara D, Maran A, Costa S, Dal Pos M, Girelli A, Lepore G, Aragona M, Iori E, Valentini U, Del Prato S, Tiengo A, Buhr A, Trevisan R, Baritussio A: In Type 1 diabetic patients with good metabolic control blood glucose variability is lower during continuous subcutaneous insulin infusion than during multiple daily injections with glargine. Diabet Med 2008;25:326-332.
46. Lepore G, Dodesini A.R., Nosari I, Trevisan R: Effect of continuous subcutaneous insulin infusion vs multiple daily insulin injection with glargine as basal insulin: an open parallel long-term study. Diabetes Nutr Metab 2004;17:84-89.
47. Garg S.K., Walker A.J., Hoff H.K., D'Souza A.O., Gottlieb P.A., Chase HP: Glycemic parameters with multiple daily injections using insulin glargine versus insulin pump. Diabetes Technol Ther 2004;6:9-15.
48. Bolli G.B., Kerr D, Thomas R, Torlone E, Sola-Gazagnes A, Vitacolonna E, Selam J.L., Home PD: Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study. Diabetes Care 2009;32:1170-1176.