EUCTR2008-006763-36-BG进行中（未招募）不适用
Randomized, double-blind study comparing the immunogenicity of two different brands of human insulin for the treatment of diabetes
Marvel Life Sciences Limited0 个研究点目标入组 500 人开始时间: 2009年3月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[[1]male and female patients suffering from type 1 or type 2 diabetes mellitus for at least 6 months before randomization
- •[2]negative screening assay for antibodies against insulin before the start of treatment
- •[3]age 18-75 years
- •[4]Body Mass Index (BMI) =35 kg/m2
- •[5]informed consent given in a written form after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[1]Previous exposure to Humulin®
- •[2]known hypersensitivity against insulin or any of the inactive components of the formulations
- •[3]known extreme resistance to insulin (daily dose of more than 200 IU)
- •[4severe renal failure (NKF stage 4-5) or patients on hemodialysis
- •[5]severe cardiac failure (NYHA III-IV)
- •[6]myocardial infarction within the last 6 months before randomization
- •[7]unstable angina pectoris
- •[8]stroke within the last 6 months before randomization
- •[9]liver failure with ascites
- •[10]severe peripheral vascular disease with ulceration or amputation
- •[11]cancer
- •[12concomitant treatment with corticosteroids (except stable dose of inhaled corticosteroids)
- •[13]concomitant treatment with immunosuppressive agents (e.g. cyclosporine A, methotrexate, etc.)
- •[14]concomitant treatment with somatotropine
- •[15]pregnancy or lactation period in female patients
- •[16]severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol or the evaluation of efficacy or safety
- •[17]anamnestic or current alcohol abuse i.e. consumption of more than 10 units of alcohol per week or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals 250 ml of beer, 125 ml wine or 25 ml of spirits)
- •[18]participation in another clinical trial within the last 12 weeks
- •[19]legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
- •[20]unreliability or lack of cooperation
- •[21]lack of a possibility to attend the visits required by protocol.
研究者
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