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KMID : 0370220060500060386
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Yakhak Hoeji
2006 Volume.50 No. 6 p.386 ~ p.392
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Systernic Review of Pramlintide, a New Drug for the Treatment of Diabetes Mellitus
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Srinivasan Shanmugam
Yong Chul-Soon
Choi Han-Gon
Jung Hee-Yong
Kim Jung-Ae
Yoo Bong-Kyu
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Abstract
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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 from 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 1 and type 2 diabetes who have failed to achieve glycemic control despite optimal therapy with insulin. However, the six pivotal Phase Ⅲ clinical trials were performed with mostly caucasian and some black and hispanic people.
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KEYWORD
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Pramlintide, Bridging study, Clinical trial, Pharmacokinetic study, Pharmacodynamic study
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