Study reanalysis using a mechanism-based pharmacokinetic/pharmacodynamic model of pramlintide in subjects with type 1 diabetes

AAPS Journal

Volumn 15, Issue 1, 2013, Pages 15-29

  Fang, Jing ^a   Landersdorfer, Cornelia B ^a,b   Cirincione, Brenda ^c   Jusko, William J ^a  

^a UNIVERSITY AT BUFFALO   (United States)

^b MONASH UNIVERSITY   (Australia)

^c AMYLIN PHARMACEUTICALS INC   (United States)

Author keywords

diabetes; glucose; pharmacodynamics; pharmacokinetics; pramlintide

Indexed keywords

PLACEBO; PRAMLINTIDE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BOLUS INJECTION; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; GLUCONEOGENESIS; GLUCOSE BLOOD LEVEL; HUMAN; IC 50; INSULIN DEPENDENT DIABETES MELLITUS; MALE; MAXIMUM PLASMA CONCENTRATION; PHARMACODYNAMICS; POPULATION MODEL; POSTPRANDIAL STATE; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; STOMACH EMPTYING; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADULT; DIABETES MELLITUS, TYPE 1; HUMANS; HYPOGLYCEMIC AGENTS; ISLET AMYLOID POLYPEPTIDE; MALE; MODELS, BIOLOGICAL; SINGLE-BLIND METHOD;

EID: 84871956361     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9409-7     Document Type: Article

References (44)

1. Aronoff SL, Berkowitz K, Shreiner B, Want L. Glucose metabolism and regulation: beyond insulin and glucagon. Diabetes Spectr. 2004;17(3):183-90.
2. Fineman MS, Koda JE, Shen LZ, Strobel SA, Maggs DG, Weyer C, et al. The human amylin analog, pramlintide, corrects postprandial hyperglucagonemia in patients with type 1 diabetes. Metab Clin Exp. 2002;51(5):636-41. (Pubitemid 34516520)
3. Gromada J, Franklin I, Wollheim CB. Alpha-cells of the endocrine pancreas: 35 years of research but the enigma remains. Endocr Rev. 2007;28(1):84-116. (Pubitemid 46220851)
4. Young A. Inhibition of glucagon secretion. Adv Pharmacol. 2005;52:151-71. (Pubitemid 43631254)
5. Evers F, Jeworrek C, Tiemeyer S, Weise K, Sellin D, Paulus M, et al. Elucidating the mechanism of lipid membrane-induced IAPP fibrillogenesis and its inhibition by the red wine compound resveratrol: a synchrotron X-ray reflectivity study. J Am Chem Soc. 2009;131(27):9516-21.
6. Konarkowska B, Aitken JF, Kistler J, Zhang S, Cooper GJ. The aggregation potential of human amylin determines its cytotoxicity towards islet beta-cells. FEBS J. 2006;273(15):3614-24. (Pubitemid 44086959)
7. Green J, Goldsbury C, Mini T, Sunderji S, Frey P, Kistler J, et al. Full-length rat amylin forms fibrils following substitution of single residues from human amylin. J Mol Biol. 2003;326(4):1147-56. (Pubitemid 36263388)
8. McQueen J. Pramlintide acetate. Am J Health Syst Pharm. 2005;62(22):2363-72. (Pubitemid 41705190)
9. Edelman SV, Garg S, Kolterman OG. Is pramlintide a safe and effective adjunct therapy for patients with type 1 diabetes? Nat Clin Pract. 2007;3(5):E1. discussion E2. (Pubitemid 46650674)
10. Hoogwerf BJ. Exenatide and pramlintide: new glucose-lowering agents for treating diabetes mellitus. Cleve Clin J Med. 2006;73(5):477-84.
11. Chase HP, Lutz K, Pencek R, Zhang B, Porter L. Pramlintide lowered glucose excursions and was well-tolerated in adolescents with type 1 diabetes: results from a randomized, single-blind, placebo-controlled, crossover study. J Pediatr. 2009;155(3):369-73.
12. Edelman S, Garg S, Frias J, Maggs D, Wang Y, Zhang B, et al. A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes. Diabetes Care. 2006;29(10):2189-95. (Pubitemid 44899850)
13. Colburn WA, Gottlieb AB, Koda J, Kolterman OG. Pharmacokinetics and pharmacodynamics of AC137 (25,28,29 tripro-amylin, human) after intravenous bolus and infusion doses in patients with insulin-dependent diabetes. J Clin Pharmacol. 1996;36(1):13-24.
14. Byon W, Fletcher CV, Brundage RC. Impact of censoring data below an arbitrary quantification limit on structural model misspecification. J Pharmacokinet Pharmacodyn. 2008;35(1):101-16. (Pubitemid 351420764)
15. Beal SL. Ways to fit a PK model with some data below the quantification limit. J Pharmacokinet Pharmacodyn. 2001;28(5):481-504. (Pubitemid 33151426)
16. Young A. Inhibition of gastric emptying. Adv Pharmacol. 2005;52:99-121. (Pubitemid 43631255)
17. Collins PJ, Horowitz M, Cook DJ, Harding PE, Shearman DJ. Gastric emptying in normal subjects - a reproducible technique using a single scintillation camera and computer system. Gut. 1983;24(12):1117-25. (Pubitemid 14205812)
18. Minami H, McCallum RW. The physiology and pathophysiology of gastric emptying in humans. Gastroenterology. 1984;86(6):1592-610. (Pubitemid 14147957)
19. Kong MF, King P, Macdonald IA, Stubbs TA, Perkins AC, Blackshaw PE, et al. Infusion of pramlintide, a human amylin analogue, delays gastric emptying in men with IDDM. Diabetologia. 1997;40(1):82-8. (Pubitemid 27035714)
20. Silber HE, Jauslin PM, Frey N, Gieschke R, Simonsson US, Karlsson MO. An integrated model for glucose and insulin regulation in healthy volunteers and type 2 diabetic patients following intravenous glucose provocations. J Clin Pharmacol. 2007;47(9):1159-71.
21. Jauslin PM, Silber HE, Frey N, Gieschke R, Simonsson US, Jorga K, et al. An integrated glucose-insulin model to describe oral glucose tolerance test data in type 2 diabetics. J Clin Pharmacol. 2007;47(10):1244-55. (Pubitemid 47459659)
22. Dalla Man C, Camilleri M, Cobelli C. A system model of oral glucose absorption: validation on gold standard data. IEEE Trans Biomed Eng. 2006;53(12):2472-8. (Pubitemid 46019534)
23. Dinneen S, Alzaid A, Turk D, Rizza R. Failure of glucagon suppression contributes to postprandial hyperglycaemia in IDDM. Diabetologia. 1995;38(3):337-43.
24. Bea SB, Broeckmann AJ, Sheiner LB, Group NP. NONMEM users guides. San Francisco, CA: University of California; 2007.
25. Karlsson MO, Jonsson EN, Wiltse CG, Wade JR. Assumption testing in population pharmacokinetic models: illustrated with an analysis of moxonidine data from congestive heart failure patients. J Pharmacokinet Biopharm. 1998;26(2):207-46. (Pubitemid 28496599)
26. Bergstrand M, Hooker AC, Wallin JE, Karlsson MO. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 2011;13(2):143-51.
27. Kong MF, Stubbs TA, King P, Macdonald IA, Lambourne JE, Blackshaw PE, et al. The effect of single doses of pramlintide on gastric emptying of two meals in men with IDDM. Diabetologia. 1998;41(5):577-83. (Pubitemid 28206829)
28. Lima JJ, Matsushima N, Kissoon N, Wang J, Sylvester JE, Jusko WJ. Modeling the metabolic effects of terbutaline in beta2-adrenergic receptor diplotypes. Clin Pharmacol Ther. 2004;76(1):27-37. (Pubitemid 38844731)
29. Lee SH, Kwon KI. Pharmacokinetic-pharmacodynamic modeling for the relationship between glucose-lowering effect and plasma concentration of metformin in volunteers. Arch Pharm Res. 2004;27(7):806-10. (Pubitemid 43086227)
30. Gumbhir-Shah K, Kellerman DJ, DeGraw S, Koch P, Jusko WJ. Pharmacokinetics and pharmacodynamics of cumulative single doses of inhaled salbutamol enantiomers in asthmatic subjects. Pulm Pharmacol Ther. 1999;12(6):353-62. (Pubitemid 30015807)
31. Brener W, Hendrix TR, McHugh PR. Regulation of the gastric emptying of glucose. Gastroenterology. 1983;85(1):76-82. (Pubitemid 13106327)
32. Horowitz M, Edelbroek MA, Wishart JM, Straathof JW. Relationship between oral glucose tolerance and gastric emptying in normal healthy subjects. Diabetologia. 1993;36(9):857-62. (Pubitemid 23248159)
33. Gedulin BR, Rink TJ, Young AA. Dose-response for glucagonostatic effect of amylin in rats. Metab Clin Exp. 1997;46(1):67-70. (Pubitemid 27052027)
34. Schvarcz E, Palmer M, Aman J, Horowitz M, Stridsberg M, Berne C. Physiological hyperglycemia slows gastric emptying in normal subjects and patients with insulin-dependent diabetes mellitus. Gastroenterology. 1997;113(1):60-6. (Pubitemid 27281758)
35. Ludvik B, Kautzky-Willer A, Prager R, Thomaseth K, Pacini G. Amylin: history and overview. Diabet Med. 1997;14 Suppl 2:S9-S13.
36. Singh-Franco D, Robles G, Gazze D. Pramlintide acetate injection for the treatment of type 1 and type 2 diabetes mellitus. Clin Ther. 2007;29(4):535-62. (Pubitemid 47016638)
37. Landersdorfer CB, He YL, Jusko WJ. Mechanism-based population modelling of the effects of vildagliptin on GLP-1, glucose and insulin in patients with type 2 diabetes. Br J Clin Pharmacol. 2012;73(3):373-90.
38. Nowak TV, Johnson CP, Kalbfleisch JH, Roza AM, Wood CM, Weisbruch JP, et al. Highly variable gastric emptying in patients with insulin dependent diabetes mellitus. Gut. 1995;37(1):23-9.
39. Young AA, Gedulin BR, Rink TJ. Dose-responses for the slowing of gastric emptying in a rodent model by glucagon-like peptide (7-36) NH2, amylin, cholecystokinin, and other possible regulators of nutrient uptake. Metab Clin Exp. 1996;45(1):1-3. (Pubitemid 26104260)
40. Ryan GJ, Jobe LJ, Martin R. Pramlintide in the treatment of type 1 and type 2 diabetes mellitus. Clin Ther. 2005;27(10):1500-12. (Pubitemid 41739488)
41. Buse JB, Weyer C, Maggs DG. Amylin replacement with pramlintide in type 1 and type 2 diabetes: a physiological approach to overcome barriers with insulin therapy. Clin Diabetes. 2002;20(3):137-44.
42. Fineman M, Weyer C, Maggs DG, Strobel S, Kolterman OG. The human amylin analog, pramlintide, reduces postprandial hyperglucagonemia in patients with type 2 diabetes mellitus. Horm Metab Res Hormon- und Stoffwechselforschung. 2002;34(9):504-8. (Pubitemid 35192237)
43. Porksen S, Nielsen LB, Kaas A, Kocova M, Chiarelli F, Orskov C, et al. Meal-stimulated glucagon release is associated with postprandial blood glucose level and does not interfere with glycemic control in children and adolescents with new-onset type 1 diabetes. J Clin Endocrinol Metab. 2007;92(8):2910-6. (Pubitemid 47236349)
44. Landersdorfer CB, Jusko WJ. Pharmacokinetic/pharmacodynamic modelling in diabetes mellitus. Clin Pharmacokinet. 2008;47(7):417-48. (Pubitemid 351861956)