RANDOMIZED STUDY TO DETERMINE EFFECTS OF SUBCUTANEOUS RECOMBINANT LEPTIN

确定皮下重组瘦素效果的随机研究

• 批准号: 6113032
• 负责人: JANET MCGILL
• 金额: $ 2.44万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6113032
• 关键词: clinical research; diabetes mellitus therapy; drug administration rate /duration; drug administration routes; drug screening /evaluation; hemoglobin As; human subject; human therapy evaluation; injection /infusion; leptin; recombinant proteins

A 16 week radomized, blinded, placebo controlled, parallel study w enrollment of approximately 150 subjects into 3 treatment groups (10mg and 20 mg r-met-HuLeptin and matched placebo [placebo pooled for analysis]). Eligible subjects will be randomized 91:1 ratio to one of the following two dose schedules: - 10mg r-met-HuLeptin/placebo injection given subcutaneously, one dailyu (QD in the morning); - 10mg r-met-HuLeptin/placebo injection given subcutaneously twice daily (BID in the morning and evening). Within each dose schedule subjects will be randomly allocated to r-met-HuLeptin or placebo in a 2:1 ratio. A minimization procedure will be used to balance the treatment groups at baseline for hemoglobin A (<10%and >10%). Subjects will receive blinded treatment for 16 weeks which may be followed by an open label maintenance study.

一项16周随机、设盲、安慰剂对照、平行研究将约150名受试者招募到3个治疗组（10 mg和20 mg r-met-HuLeptin和匹配的安慰剂[安慰剂汇总用于分析]）。符合条件的受试者将以91：1的比例随机分配至以下两个剂量方案之一：-每天一次皮下给予10 mg r-met-HuLeptin/安慰剂注射液（早晨QD）; -每天两次皮下给予10 mg r-met-HuLeptin/安慰剂注射液（早晨和晚上BID）。在每个剂量方案中，受试者将以2：1的比例随机分配至r-met-HuLeptin或安慰剂组。 将使用最小化程序来平衡基线时血红蛋白A（10%）的治疗组<10%and >。 受试者将接受为期16周的盲态治疗，随后可能进行开放标签维持研究。