NCT00519558已完成3 期
Investigation of the Efficacy and Safety of NN-220 for 24 Weeks in Adults With Growth Hormone Deficiency
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Percent change in truncal fat (kg) from baseline
研究概览
简要总结
This trial is conducted in Japan. The aim of this trial is to demonstrate superiority of the effect of NN-220 compared with that of placebo as assessed by the change in percent in truncal fat (kg) from baseline to 24 weeks' treatment (end of treatment) in patients with Growth Hormone Deficiency in Adults (GHDA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with diagnosed GHD
- •If the subject has a history of treatment of treatment for a tumour of pituitary or peripheral site, two years or more must have passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded
- •Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies
排除标准
- •Subject with a history of acromegaly
- •Subject with diabetes mellitus
- •Subject suffering from malignancy
- •Several medical conditions
结局指标
主要结局
Percent change in truncal fat (kg) from baseline
时间窗: at 24 weeks (end of treatment)
次要结局
- FPG, insulin, and HbA1c
- Change in total body fat, total LBM, etc. from baseline to 24 weeks
- Clinical laboratory tests
- Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
- IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio
- Adverse events
研究者
研究点 (2)
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