The Journal of Pediatrics
Volume 155, Issue 3 , Pages 369-373 , September 2009

Pramlintide Lowered Glucose Excursions and Was Well-Tolerated in Adolescents with Type 1 Diabetes: Results from a Randomized, Single-Blind, Placebo-Controlled, Crossover Study

  • H. Peter Chase, MD

      Affiliations

    • Barbara Davis Center for Childhood Diabetes, University of Colorado, Aurora, CO
    • Corresponding Author InformationReprint requests: H. Peter Chase, MD, Professor of Pediatrics, Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, PO Box 6511, 1775 Aurora Ct, Rm 1304, Aurora, CO 80045-6511.
    • ,
  • Karen Lutz, PhD

      Affiliations

    • Amylin Pharmaceuticals, Inc, San Diego, CA
    • ,
  • Richard Pencek, PhD

      Affiliations

    • Amylin Pharmaceuticals, Inc, San Diego, CA
    • ,
  • Bei Zhang, MD

      Affiliations

    • Amylin Pharmaceuticals, Inc, San Diego, CA
    • ,
  • Lisa Porter, MD

      Affiliations

    • Amylin Pharmaceuticals, Inc, San Diego, CA

Received 13 November 2008 ,Revised 5 February 2009 ,Accepted 13 March 2009.

References 

  1. Centers for Disease Control and Prevention. National Diabetes Fact Sheet: General Information and National Estimates on Diabetes in the United States, 2007. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2007;
  2. Diabetes Control and Complications Trial Research Group. Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. J Pediatr. 1994;125:177–188
  3. Levine BS, Anderson BJ, Butler DA, Antisdel JE, Brackett J, Laffel LMB. Predictors of glycemic control and short-term adverse outcomes in youth with type 1 diabetes. J Pediatr. 2001;139:197–203
  4. Mortensen HB, Hougaard P. Comparison of metabolic control in a cross-sectional study of 2,873 children and adolescents with IDDM from 18 countries. Diabetes Care. 1997;20:714–720
  5. Rosilio M, Cotton JB, Wieliczko MC, Gendrault B, Carel JC, Couvaras O, et al. Factors associated with glycemic control: a cross-sectional nationwide study in 2,579 French children with type 1 diabetes. The French Pediatric Diabetes Group. Diabetes Care. 1998;21:1146–1153
  6. Young AA. Amylin's physiology and its role in diabetes. Curr Opin Endocrinol Diabetes. 1997;4:282–290
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  8. Levetan C, Want LL, Weyer C, Strobel SA, Crean J, Wang Y, et al. Impact of pramlintide on glucose fluctuations and postprandial glucose, glucagon, and triglyceride excursions among patients with type 1 diabetes intensively treated with insulin pumps. Diabetes Care. 2003;26:1–8
  9. Chapman I, Parker B, Doran S, Feinle-Bisset C, Wishart J, Strobel S, et al. Effect of pramlintide on satiety and food intake in obese subjects and subjects with type 2 diabetes. Diabetologia. 2005;48:838–848
  10. Whitehouse F, Kruger DF, Fineman M, Shen L, Ruggles JA, Maggs DG, 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;25:724–730
  11. Ratner RE, Dickey R, Fineman M, Maggs DG, Shen L, Strobel SA, et al. Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in type 1 diabetes mellitus: a 1-year, randomized controlled trial. Diabetes Med. 2004;21:1204–1212
  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;29:2189–2195
  13. Weyer C, Gottlieb A, Kim DD, Lutz K, Schwartz S, Gutierrez M, 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;26:3074–3079
  14. Hollander PA, Levy P, Fineman MS, Maggs DG, Shen LZ, Strobel SA, et al. Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a one-year randomized controlled trial. Diabetes Care. 2003;26:784–790
  15. Ratner RE, Want LL, Fineman MS, Velte MJ, Ruggles JA, Gottlieb A, et al. Adjunctive therapy with the amylin analogue pramlintide leads to a combined improvement in glycemic and weight control in insulin-treated subjects with type 2 diabetes. Diabetes Technol Ther. 2002;4:51–61
  16. SYMLIN (pramlintide acetate) injection: prescribing information. Amylin Pharmaceuticals, Inc. Available at http://www.symlin.com/. Accessed August 21, 2008.
  17. Kellmeyer TA, Kesty NC, Want Y, Frias JP, Fineman MS. Pharmacokinetics of an oral drug (acetaminophen) administered at various times relative to subcutaneous injection of pramlintide in subjects with type 2 diabetes. J Clin Pharmacol. 2007;47:789–805
  18. Libman IM, Pietropaolo M, Arslanian SA, LaPorte RE, Becker DJ. Changing prevalence of overweight children and adolescents at onset of insulin-treated diabetes. Diabetes Care. 2003;26:2871–2875
  19. 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;329:977–986
  20. Ceriello A. Oxidative stress and diabetes-associated complications. Endocr Pract. 2006;12(Suppl 1):60–62
  21. Diabetes Control and Complications Trial (DCCT) and Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Beneficial effects of intensive therapy of diabetes during adolescence: outcomes after the conclusion of the Diabetes Control and Complications Trial (DCCT). J Pediatr. 2001;139:804–812
  22. Heptulla RA, Rodriguez LM, Bomgaars L, Haymond MW. The role of amylin and glucagon in the dampening of glycemic excursions in children with type 1 diabetes. Diabetes. 2005;54:1100–1107
  23. Rodriguez LM, Mason KJ, Haymond MW, Heptulla RA. The role of prandial pramlintide in the treatment of adolescents with type 1 diabetes. Pediatr Res. 2007;62:746–749
  24. Burdick P, Kishiyama CM, Messer VL, Cobry E, Weimer C, Scrimgeou L, et al. Pramlintide usage in adolescents with type 1 diabetes. [abstract] Diabetes. 2008;57(Suppl 1):A500

 H.P.C. has received research funding from Amylin Pharmaceuticals, Inc. K.L., R.P., B.Z., and L.P. are all employees and stockholders of Amylin Pharmaceuticals, Inc.

PII: S0022-3476(09)00245-5

doi: 10.1016/j.jpeds.2009.03.012

The Journal of Pediatrics
Volume 155, Issue 3 , Pages 369-373 , September 2009

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