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INSULIN HPN & REGULAR PREMIX RATIO 50 & 50 VS PREMIX RATIOS 70 & 30

INSULIN HPN & REGULAR PREMIX RATIO 50 & 50 VS PREMIX RATIOS 70 & 30
胰岛素 HPN
批准号:
6304646
负责人:
MARY KORYTKOWSKI
金额:
$0.3万
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-12-01 至 2000-11-30

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中文摘要
翻译
本研究的具体目的是证明胰岛素50/50(NPH/R)与胰岛素70/30(NPH/R)不同,通过注射后前4小时内输注的葡萄糖总量进行测量。 本研究将研究每5单位常规胰岛素含5单位NPH的预混胰岛素制剂(50/50)和(70/30)胰岛素制剂之间的差异。 将在健康男性中进行两次12小时正葡萄糖钳夹程序。 受试者将以设盲方式皮下注射0.2单位的50/50或70/30胰岛素制剂。 将以滴定的剂量输注20%葡萄糖以维持正常。 主要疗效指标是注射后前4小时内维持正常血糖所需的葡萄糖输注速率差异。
英文摘要
The specific objective of this study is to demonstrate that insulin 50/50 (NPH/R) is different from insulin 70/30 (NPH/R) as measured by the total amount of glucose infused during the first four hours after injection. This study will investigate differences between a premixed insulin preparation containing 5 units NPH for every 5 units regular insulin (50/50) and a (70/30) insulin preparation. Two 12 hour euglycemic clamp procedures will be performed in healthy men. Subjects will receive 0.2 units subcutaneously of the 50/50 or 70/30 insulin preparation in a blinded manner. Twenty percent dextrose will be infused at a dose titrated to maintain euglycemia. The primary efficacy measure will be the difference in glucose infusion rates required to maintain euglycemia during the first 4 hours after injection.
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