Pramlintide for the treatment of insulin-requiring diabetes mellitus: Rationale and review of clinical data

Drugs

Volumn 64, Issue 13, 2004, Pages 1419-1432

  Kruger, Davida F ^a   Gloster, Maurice A ^b  

^a HENRY FORD HEALTH SYSTEM   (United States)

^b AMYLIN PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADRENOMEDULLIN; AMINO ACID; AMYLIN; CALCITONIN; GLUCAGON; GLUCAGON LIKE PEPTIDE 1; GLUCOSE; HEMOGLOBIN A1C; INSULIN; INSULIN LISPRO; PRAMLINTIDE;

CIRCADIAN RHYTHM; CLINICAL TRIAL; DIABETES CONTROL; DRUG BINDING; DRUG EFFECT; DYSLIPIDEMIA; GLUCAGON RELEASE; GLUCOSE BLOOD LEVEL; GLUCOSE TRANSPORT; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; MICROANGIOPATHY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; POSTPRANDIAL STATE; REVIEW; STOMACH EMPTYING; SYSTEMIC CIRCULATION; WEIGHT REDUCTION;

AMYLOID; ANIMALS; CLINICAL TRIALS; DIABETES MELLITUS, TYPE 1; GLUCAGON; GLUCAGON-LIKE PEPTIDE 1; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; PEPTIDE FRAGMENTS; PROTEIN PRECURSORS;

EID: 3242752688     PISSN: 00126667     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003495-200464130-00003     Document Type: Review

References (98)

1. Unger RH, Aguilar-Parada E, Muller WA, et al. Studies of pancreatic alpha cell function in normal and diabetic subjects. J Clin Invest 1970; 49 (4): 837-48
2. Diabetes Control and Complications Trial Research Group. Epidemiology of severe hypoglycemia in the Diabetes Control and Complications Trial. Am J Med 1991; 90 (4): 450-9
3. Diabetes Control and Complications Trial Research Group. Hypoglycemia in the Diabetes Control and Complications Trial. Diabetes 1997; 46 (2): 271-86
4. UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352 (9131): 837-53
5. Cryer PE, Binder C, Bolli GB, et al. Hypoglycemia in IDDM. Diabetes 1989; 38 (9): 1193-9
6. Cryer PE. Banting Lecture, hypoglycemia: the limiting factor in the management of IDDM. Diabetes 1994; 43 (11): 1378-89
7. Kaufman FR, Halvorson M, Miller D, et al. Insulin pump therapy in type 1 pediatric patients: now and into year 2000. Diabetes Metab Res Rev 1999 15 (5): 338-352
8. DeFronzo RA. Pharmacologic therapy for type 2 diabetes mellitus. Ann Intern Med 1999; 131 (4): 281-303
9. Hirsch IB. Type 1 diabetes mellitus and the use of flexible insulin regimens. Am Fam Physician 1999; 60 (8): 2343-52
10. Bolli GB, Di Marchi RD, Park GD, et al. Insulin analogues and their potential in the management of diabetes mellitus. Diabetologia 1999; 42 (10): 1151-67
11. Jacobs MA, Keulen ET, Kanc K, et al. Metabolic efficacy of preprandial administration of Lys(B28), Pro(B29) human insulin analog in IDDM patients: a comparison with human regular insulin during a three-meal test period. Diabetes Care 1997; 20 (8): 1279-86
12. Heinemann L, Heise T, Wahl LC, et al. 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; 13 (7): 625-9
13. Bruttomesso D, Pianta A, Mari A, et al. Restoration of early rise in plasma insulin levels improves the glucose tolerance of type 2 diabetic patients. Diabetes 1999; 48 (1): 99-105
14. Boland EA, Tamborlane WV. Continuous glucose monitoring in youth with type 2 diabetes: overcoming barriers to successful treatment. Diabetes Technol Ther 2000; 2 Suppl. 1: S53-9
15. Boland E, Monsod T, Delucia M, et al. Limitations of conventional methods of self-monitoring of blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care 2001; 24 (11): 1858-62
16. Bryden KS, Neil A, Mayou RA, et al. Eating habits, body weight, and insulin misuse: a longitudinal study of teenagers and young adults with type 1 diabetes. Diabetes Care 1999; 22 (12): 1956-60
17. McConnell EM, Harper R, Campbell M, et al. Achieving optimal diabetic control in adolescence: the continuing enigma. Diabetes Metab Res Rev 2001; 17 (1): 67-74
18. Purnell JQ, Hokanson JE, Marcovina SM, et al. Effect of excessive weight gain with intensive therapy of type 1 diabetes on lipid levels and blood pressure: results from the DCCT. Diabetes Control and Complications Trial. JAMA 1998; 280 (2): 140-6
19. Weyer C, Maggs DG, Young AA, et al. Amylin replacement with pramlintide as an adjunct to insulin therapy in type 1 and type 2 diabetes mellitus: a physiological approach toward improved metabolic control. Curr Pharm Des 2001; 7 (14): 1353-73
20. Unger RH, Orci L. The role of glucagon in the endogenous hyperglycemia of diabetes mellitus. Annu Rev Med 1977; 28: 119-30
21. Gerich JE, Schnieder V, Dippe SE, et al. Characterization of the glucagon response to hypoglycemia in man. J Clin Endocrinol Metab 1974; 38 (1): 77-82
22. Kieffer TJ, Habener JF. The glucagon-like peptides. Endocr Rev 1999; 20 (6): 876-913
23. Orskov C, Rabenhoj L, Wettergren A, et al. Tissue and plasma concentrations of amidated and glycine-extended glucagon-like peptide I in humans. Diabetes 1994; 43 (4): 535-9
24. Holst JJ, Orskov C. Incretin hormones: an update. Scand J Clin Lab Invest Suppl 2001; (234): 75-85
25. Creutzfeldt W. The entero-insular axis in type 2 diabetes: incretins as therapeutic agents. Exp Clin Endocrinol Diabetes 2001; 109 Suppl. 2: S288-303
26. Turton MD, O'Shea D, Gunn I, et al. A role for glucagon-like peptide-1 in the central regulation of feeding. Nature 1996; 379 (6560): 69-72
27. Meeran K, O'Shea D, Mark C, et al. Repeated intracerebroventricular administration of glucagon-like peptide-1-(7-36) amide or exendin -(9-39) alters body weight in the rat. Endocrinology 1999; 140(1): 244-50
28. 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 (14): 977-86
29. Diabetes Control and Complications Trial Research Group. The absence of a glycemic threshold for the development of long-term complications: the perspective of the Diabetes Control and Complications Trial. Diabetes 1996; 45 (10): 1289-98
30. Lasker RD. The diabetes control and complications trial: implications for policy and practice. N Engl J Med 1993; 329 (14): 1035-6
31. American Diabetes Association. Implications of the Diabetes Control and Complications Trial. Diabetes Care 2000; 23 Suppl. 1: S24-6
32. Diabetes Control and Complications Trial Research Group. Weight gain associated with intensive therapy in the diabetes control and complications trial: the DCCT Research Group. Diabetes Care 1988; 11 (7): 567-73
33. Diabetes Control and Complications Trial Research Group. Influence of intensive diabetes treatment on body weight and composition of adults with type 1 diabetes in the Diabetes Control and Complications Trial. Diabetes Care 2001; 24 (10): 1711-21
34. UK Prospective Diabetes Study Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998; 352 (9139): 854-65
35. UK Prospective Diabetes Study Group. Overview of 6 years' therapy of type II diabetes: a progressive disease. Diabetes 1995; 44: 1249-58
36. Nathan DM. Some answers, more controversy, from UKPDS: United Kingdom Prospective Diabetes Study. Lancet 1998; 352 (9131): 832-3
37. American Diabetes Association. Implications of the United Kingdom Prospective Diabetes Study. Diabetes Care 2000; 23 Suppl. 1: S27-31
38. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl J Med 2000; 342 (6): 381-9
39. Cooper GJ, Willis AC, Clark A, et al. Purification and characterization of a peptide from amyloid-rich pancreases of type 2 diabetic patients. Proc Natl Acad Sci U S A 1987; 84 (23): 8628-32
40. Cockburn DC, Holt SM, Roberts AN, et al. Localization of the amylin locus to chromosome 12 [abstract no. 2614]. Cytogenet Cell Genet 1989; 51: 977
41. Cooper GJ. Amylin compared with calcitonin gene-related peptide: structure, biology, and relevance to metabolic disease. Endocr Rev 1994; 15 (2): 163-201
42. Young AA, Wang MW, Gedulin B, et al. Diabetogenic effects of salmon calcitonin are attributable to amylin-like activity. Metabolism 1995; 44 (12): 1581-9
43. Lukinius A, Korsgren O, Grimelius L, et al. Expression of islet amyloid polypeptide in fetal and adult porcine and human pancreatic islet cells. Endocrinology 1996; 137 (12): 5319-25
44. Badman MK, Jermany JL, Shennan KIJ, et al. Pro-islet amyloid polypeptide is cleaved by the endopeptidase PC2 but not by furin [abstract no. 99], Diabetologia 1995; 38 Suppl. 1: A27
45. Koda JE, Fineman MS, Kolterman OG, et al. 24 hour plasma amylin profiles are elevated in IGT subjects vs. normal controls [abstract no. 876]. Diabetes 1995; 44 Suppl. 1: 238A
46. Koda JE, Fineman M, Rink TJ, et al. Amylin concentrations and glucose control. Lancet 1992; 339 (8802): 1179-80
47. Fineman MS, Giotta MP, Thompson RG, et al. Amylin response following Sustacal® ingestion is diminished in type II diabetic patients treated with insulin [abstract no. 566]. Diabetologia 1996; 39 Suppl. 1: A149
48. Kruger DF, Gatcomb PM, Owen SK. Clinical implications of amylin and amylin deficiency. Diabetes Educ 1999; 25 (3): 389-97
49. Gedulin B, Jodka C, Green D, et al. Amylin inhibition of arginine-induced glucagon secretion: comparison with glucagon-like-peptide-1 (7-36)-amide (GLP-1) [abstract no. 584]. Diabetologia 1996; 39 Suppl. 1: A154
50. Gedulin BR, Rink TJ, Young AA. Dose-response for glucagonostatic effect of amylin in rats. Metabolism 1997; 46 (1): 67-70
51. Gedulin B, Jodka C, Percy A, et al. Neutralizing antibody and the antagonist AC187 may inhibit glucagon secretion in rats [abstract no. 0911]. Diabetes 1997; 40 Suppl. 1: 238A
52. Silvestre RA, Rodriguez-Gallardo J, Jodka C, et al. Selective amylin inhibition of the glucagon response to arginine is extrinsic to the pancreas. Am J Physiol 2001; 280 (3): E443-9
53. Young AA, Gedulin B, Vine W, et al. Gastric emptying is accelerated in diabetic BB rats and is slowed by subcutaneous injections of amylin. Diabetologia 1995; 38 (6): 642-8
54. 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. Metabolism 1996; 45 (1): 1-3
55. Rushing PA. Central amylin signaling and the regulation of energy homeostasis. Curr Pharm Des 2003; 9 (10): 819-25
56. Rushing PA, Hagan MM, Seeley RJ, et al. Amylin: a novel action in the brain to reduce body weight. Endocrinology 2001; 41 (2): 850-3
57. Young A, Moore C, Herich J, et al. Neuroendocrine actions of amylin. In: Poyner D, Marshall I, Brain SD, editors. The CGRP family: calcitonin gene-related peptide (CGRP), amylin, and adrenomedullin. Georgetown (TX): Landes Bioscience, 2000: 91-102
58. Beaumont K, Kenney MA, Young AA, et al. High affinity amylin binding sites in rat brain. Mol Pharmacol 1993; 44 (3): 493-7
59. Christopoulos G, Paxinos G, Huang XF, et al. Comparative distribution of receptors for amylin and the related peptides calcitonin gene related peptide and calcitonin in rat and monkey brain. Can J Physiol Pharmacol 1995; 73 (7): 1037-41
60. Sexton PM, Perry KJ. Amylin receptors in the central nervous system. Recent Res Dev Neurochem 1996; 1: 157-66
61. van Rossum D, Menard DP, Fournier A, et al. Autoradiographic distribution and receptor binding profile of [I-125]Bolton Hunter-rat amylin binding sites in the rat brain. J Pharmacol Exp Ther 1994; 270 (2): 779-87
62. Sexton PM, Paxinos G, Kenney MA, et al. In vitro autoradiographic localization of amylin binding sites in rat brain. Neuroscience 1994; 62 (2): 553-67
63. Riediger T, Rauch M, Jurat G, et al. Cellular mechanisms of amylin activating area postrema and subfornical organ neurons [abstract no. 856.2]. Soc Neurosci Abstr 1999; 25 (2): 2140
64. Edwards GL, Gedulin BR, Jodka C, et al. Area postrema (AP)-lesions block the regulation of gastric emptying by amylin [abstract no. P133]. Neurogastroenterol Motil 1998; 10 (4): 26
65. Jodka C, Green D, Young A, et al. Amylin modulation of gastric emptying in rats depends upon an intact vagus nerve [abstract no. 867]. Diabetes 1996; 45 Suppl. 2: 235A
66. Nyholm B, Brock B, Ørskov L, et al. Amylin receptor agonists: a novel pharmacological approach in the management of insulin-treated diabetes mellitus. Expert Opin Investig Drugs 2001; 10(9): 1-12
67. Janes S, Gaeta L, Beaumont K, et al. The selection of pramlin-tide for clinical evaluation [abstract no. 865]. Diabetes 1996; 45 Suppl. 2: 235A
68. Young AA, Vine W, Gedulin BR, et al. Preclinical pharmacology of pramlintide in the rat: comparisons with human and rat amylin. Drug Dev Res 1996; 37 (4): 231-48
69. Fineman MS, Koda JE, Shen LZ, et al. The human amylin analog, pramlintide, corrects postprandial hyperglucagonemia in patients with type 1 diabetes. Metabolism 2002; 51 (5): 636-41
70. Fineman M, Weyer C, Maggs DG, et al. The human amylin analog, pramlintide, reduces postprandial hyperglucagonemia in patients with type 2 diabetes mellitus. Horm Metab Res 2002; 34: 504-8
71. Nyholm B, Ørskov L, Hove K, et al. The amylin analog pramlintide improves glycemic control and reduces postprandial glucagon concentrations in patients with type 1 diabetes mellitus. Metabolism 1999; 48 (7): 935-41
72. Kong MF, Stubbs TA, King P, 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
73. Kong MF, King P, Macdonald IA, et al. Infusion of pramlintide, a human amylin analogue, delays gastric emptying in men with IDDM. Diabetologia 1997; 40: 82-8
74. Kong M-FS-C, Macdonald IA, Tattersall RB. Gastric emptying in diabetes. Diabet Med 1996 13 (2): 112-119
75. Thompson RG, Gottlieb A, Organ K, et al. Pramlintide: a human amylin analogue reduced postprandial plasma glucose, insulin and c-peptide concentrations in patients with type II diabetes. Diabet Med 1997; 14 (7): 547-55
76. Kolterman OG, Schwartz S, Corder C, et al. Effect of 14 days' subcutaneous administration of the human amylin analogue, pramlintide (AC137), on an intravenous insulin challenge and response to a standard liquid meal in patients with IDDM. Diabetologia 1996; 39 (4): 492-9
77. Thompson RG, Peterson J, Gottlieb A, et al. Effects of pramlin-tide, an analog of human amylin, on plasma glucose profiles in patients with IDDM: results of a multicenter trial. Diabetes 1997: 46 (4): 63263-6
78. Kolterman OG, Gottlieb A, Moyses C, et al. Reduction of postprandial hyperglycemia in subjects with IDDM by intravenous infusion of AC 137, a human amylin analogue. Diabetes Care 1995; 18(8): 1179-82
79. Levetan C, Want LL, Weyer C, et al. Impact of pramlintide on glucose fluctuations and postprandial glucose, glucagon, and triglycerides excursions among patients with type 1 diabetes intensively treated with insulin pumps. Diabetes Care 2003; 26 (1): 1-8
80. Whitehouse F, Kruger DF, Fineman M, et al. A randomized study and open-label extension evaluating the long-term efficacy of pramlintide as an adjunct to insulin therapy in type 1 diabetes. Diabetes Care 2002; 25 (4): 724-30
81. Hollander PA, Levy P, Fineman MS, et al. Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes. Diabetes Care 2003; 26 (3): 784-90
82. Thompson RG, Pearson L, Schoenfeld SL, et al. Pramlintide, a synthetic analog of human amylin, improves the metabolic profile of patients with type 2 diabetes using insulin: the Pramlintide in Type 2 Diabetes Group. Diabetes Care 1998; 21 (6): 987-93
83. Ratner RE, Want LL, Fineman MS, et al. Adjunctive therapy with the amylin analogue pramlintide leads to a combined improvement in glycemic and weight control in insulin-treated patients with type 2 diabetes. Diabetes Technol Ther 2002; 4 (1): 51-61
84. Gottlieb A, Velte M, Fineman M, et al. Pramlintide as an adjunct to insulin therapy improved glycemic and weight control in people with type 1 diabetes during treatment for 52 weeks [abstract no. 439-P]. Diabetes 2000; 49 (1): A109
85. Kolterman O, Fineman M, Burrell T, et al. Adjunctive therapy with pramlintide lowered A1C without an increase in overall severe hypoglycemia event rate in patients with type 1 diabetes approaching ADA glycemic targets [abstract no. 532-P]. Diabetes 2003; 52 Suppl. 1: A124
86. Hollander P, Maggs DG, Ruggles JA, et al. Effect of pramlintide on weight in overweight and obese insulin-treated patients. Diabetes Obes Metab 2004; 12: 661-8
87. Pehling G, Tessari P, Gerich JE, et al. Abnormal meal carbohydrate disposition in insulin-dependent diabetes: relative contributions of endogenous glucose production and initial splanchnic uptake and effect of intensive insulin therapy. J Clin Invest 1984; 74 (3): 985-91
88. Dinneen S, Alzaid A, Turk D, et al. Failure of glucagon suppression contributes to postprandial hyperglycaemia in IDDM. Diabetologia 1995; 38: 337-43
89. Dinneen S, Gerich J, Rizza R. Carbohydrate metabolism in non-insulin-dependent diabetes mellitus. N Engl J Med 1992; 327 (10): 707-13
90. Firth RG, Bell PM, Marsh HM. et al. Postprandial hyperglycemia in patients with noninsulin-dependent diabetes mellitus. Role of hepatic and extrahepatic tissues. J Clin Invest 1986; 77 (5): 1525-32
91. Edelman SV, Weyer C. Unresolved challenges with insulin therapy in type 1 and type 2 diabetes: potential benefit of replacing amylin, a second β-cell hormone. Diabetes Tech Ther 2002; 4: 175-89
92. Weyer C, Gottlieb A, Kim D, et al. Pramlintide reduces postprandial glucose excursions when added to regular insulin or insulin lispro in subjects with type 1 diabetes: a dose-timing study. Diabetes Care 2003; 26 (11): 3074-9
93. Maggs DG, Fineman M, Kornstein J, et al. Pramlintide reduces postprandial glucose excursions when added to insulin lispro in subjects with type 2 diabetes: a dose-timing study. Diabetes Metab Res Rev 2004; 20: 55-60
94. Data on file, Amylin Pharmaceuticals Inc., 2002
95. Bhavsar S, Watkins J, Young A. Comparison of central and peripheral administration of amylin on reduction of food intake in rats [abstract no. 1187]. Diabetologia 1997; 40 Suppl. 1: A302
96. Rushing PA, Lutz TA, Seeley RJ, et al. Amylin and insulin interact to reduce food intake in rats. Horm Metab Res 2000; 32: 62-5
97. Heise T, Heinemann L, Maggs D, et al. Pramlintide does not impair symptomatic or catecholaminergic responses to hypoglycemia [abstract no. 2007-PO]. Diabetes 2003; 52 Suppl. 1: A463
98. Kolterman O, Burrell T, Shen L, et al. Initiation of pramlintide using dose-titration in intensively-treated patients with type 1 diabetes resulted in mitigation of nausea and hypoglycemia [abstract no. 62-LB]. Presented at the 2003 American Diabetes Association Meeting; 2003 Jun 13-17; New Orleans