Systemic Review of Pramlintide, a New Drug for the Treatment of Diabetes Mellitus

새로운 당뇨병 치료제 Pramlintide의 Systematic Review

  • Published : 2006.12.31

Abstract

Pramlintide, a synthetic analogue of human hormone amylin, is the first of a new class of amylinomimetic compounds. Present study was undertaken to compile and analyze the clinical trials of pramlintide, and thereby to facilitate the design of the bridging study for the earlier introduction of the drug, which might be needed by diabetes patients in Korea. Sixty-two articles from Pubmed and MEDLINE search were used to analyze the trials of pramlintide along with prescribing information and New Drug Application packet obtained form the manufacturer. The efficacy of the new drug was attributed to three mechanisms: delay of gastric emptying time, inhibition of post-prandial glucagon secretion, and reduction of food intake by enhanced satiety. Clinical trials consistently identified the effectiveness of the drug for the treatment of type 1and type 2 diabetes who have failed to achieve glycemic control despite optimal therapy with insulin. However, the six pivotal Phase III clinical trials were peformed with mostly caucasian and some black and hispanic people. None of the trials documented the proportion of either Asian or Korean participants. Since Korean diabetes patients show different epidemiology and characteristics in their disease state, it appears that the bridging study of pramlintide should be designed in the level of full scale Phase III clinical trial along with pharmacokinetic and pbarmacodynamic studies.

Keywords

References

  1. Havas, S. and Donner, T. : Tight control of type 1 diabetes: recommendations for patients. Am. Fam. Physician 74, 971 (2006)
  2. Cramer, J. A. : A systematic review of adherence with medications for diabetes. Diabetes Care 27, 1218 (2004) https://doi.org/10.2337/diacare.27.5.1218
  3. Stumvoll, M., Goldstein, B. J. and van Haeften, T. W. : Type 2 diabetes: principles of pathogenesis and therapy. Lancet 365, 1333 (2005) https://doi.org/10.1016/S0140-6736(05)61032-X
  4. Vivian, E. M., Olarte, S. V. and Gutierrez, A. M. : Insulin strategies for type 2 diabetes mellitus. Ann. Pharmacother. 38, 1916 (2004) https://doi.org/10.1345/aph.1D635
  5. 식품의약품안전청 의약품안전국 : 외국임상자료의 평가, 가교자료 평가 및 가교시험 결정을 위한 가이드라인. 의약 65625-13552호(2000. 12. 29)
  6. Kong, M. F., Stubbs, T. A., King, P., Macdonald, I. A., Lambourne, J. E., Blackshaw, P. E., Perkins, A. C. and Tattersall, R. B. : The effect of single doses of pramlintide on gastric emptying of two meals in men with IDDM. Diabetologia 41, 577 (1998) https://doi.org/10.1007/s001250050949
  7. Fineman, M., Weyer, C., Maggs, D. G., Strobel, S. and Kolterman, O. G. : The human amylin analog, pramlintide, reduces postprandial hyperglucagonemia in patients with type 2 diabetes mellitus. Horm. Metab. Res. 34, 504 (2002) https://doi.org/10.1055/s-2002-34790
  8. Chapman, I., Parker, B., Doran, S., Feinle-Bisset, C., Wishart, J., Strobel, S., Wang, Y., Burns, C., Lush, C., Weyer, C. and Horowitz, M. : Effect of pramlintide on satiety and food intake in obese subjects and subjects with type 2 diabetes. Diabetologia 48, 838 (2005) https://doi.org/10.1007/s00125-005-1732-4
  9. Kong, M. F., King, P., Macdonald, I. A., Stubbs, T. A., Perkins, A. C., Blackshaw, P. E., Moyses, C. and Tattersall, R. B. : Infusion of pramlintide, a human amylin analogue, delays gastric emptying in men with IDDM. Diabetologia 40, 82 (1997) https://doi.org/10.1007/s001250050646
  10. Nyholm, B., Orskov, L., Hove, K. Y., Gravholt, C. H., Moller, N., Alberti, K. G., Moyses, C., Kolterman, O. and Schmitz, O. : The amylin analog pramlintide improves glycemic control and reduces postprandial glucagon concentrations in patients with type 1 diabetes mellitus. Metabolism 48, 935 (1999) https://doi.org/10.1016/S0026-0495(99)90232-9
  11. Fineman, M. S., Koda, J. E., Shen, L. Z., Strobel, S. A., Maggs, D. G., Weyer, C. and Kolterman, O. G. : The human amylin analog, pramlintide, corrects postprandial hyperglucagonemia in patients with type 1 diabetes. Metabolism 51, 636 (2002) https://doi.org/10.1053/meta.2002.32022
  12. Symlin (pramlintide acetate) injection package insert. San Diego, CA: Amylin Pharmaceuticals, Inc. (2005)
  13. McQueen J. Pramlintide acetate. Am. J. Health-Sys. Pharm. 62, 2363 (2005) https://doi.org/10.2146/ajhp050341
  14. Amylin Pharmaceuticals, Inc. Study 137-125 (An open-label, randomized, four-period cross-over study in normal volunteers of the bioavailability of selected concentrations of pramlintide in two different formulations) filed in NDA 21-332 (2000)
  15. Cada, D. J., Levien, T. and Baker, D. E. : Pramlintide acetate. Hospital Pharmacy 40, 599 (2005) https://doi.org/10.1177/001857870504000709
  16. Amylin Pharmaceuticals, Inc. Study 137-119 (An open-lable, randomized, five-period cross-over study of the pharmacokinetics of subcutaneous pramlintide (AC137) versus placebo plus NPH and regular insulin mixed together and as separate single injections in patients with type 1 diabetes mellitus) filed in NDA 21-332 (2000)
  17. Amylin Pharmaceuticals, Inc. Study 137-133 (A randomized, double-blind, placebo-controlled, single-dose, two-period cross-over study to evaluate the effect of pramlintide on the pharmacokinetics of ethinyl estradiol and norgestrel in healthy female subjects receiving the oral contraceptive, Lo/Ovral) filed in NDA 21-332 (2000)
  18. Amylin Pharmaceuticals, Inc. Study 137-134 (A randomized, double-blind, placebo-controlled, single-dose, two-period cross-over study to determine the effect of pramlintide on the pharmacokinetics of ampicillin in healthy subjects) filed in NDA 21-332 (2000)
  19. Fineman, M., Gottlieb, A., Bahner, A., Parker, J., Waite, G. and Kolterman, O. : Pramlintide therapy in addition to insulin in type 1 diabetes on metabolic control after 6 months. Diabetologia 42(suppl 1), Abstract 872 (1999)
  20. Whitehouse, F., Kruger, D. F., Fineman, M., Shen, L., Ruggles, J. A., Maggs, D. G., Weyer, C. and Kolterman, O. G. : 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 25, 724 (2002) https://doi.org/10.2337/diacare.25.4.724
  21. Ratner, R. E., Dickey, R., Fineman, M., Maggs, D. G., Shen, L., Strobel, S. A., Weyer, C. and Kolterman, O. G. : 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. Diabet. Med. 21, 1204 (2004) https://doi.org/10.1111/j.1464-5491.2004.01319.x
  22. Gottlieb, A., Fineman, M., Bahner, A., Parker, J., Waite O. and Kolterman, O. : Pramlintide therapy in addition to insulin in type 2 diabetes on metabolic control after 6 months. Diabetologia 42(suppl 1), Abstract 873 (1999)
  23. Ratner, R. E., Want, L. L., Fineman, M. S., Velte, M. J., Ruggles, J. A., Gottlieb, A., Weyer, C. and Kolterman, O. G. : 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. 4, 51 (2002).) https://doi.org/10.1089/15209150252924094
  24. Hollander, P. A., Levy, P., Fineman, M. S., Maggs, D. G., Shen, L. Z., Strobel, S. A., Weyer, C. and Kolterman, O. G. : Pramlintide as an adjunct to insulin therapy improves longterm glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care 26, 784 (2003) https://doi.org/10.2337/diacare.26.3.784