CTRI/2009/091/000862已完成3 期
Randomized, double-blind study comparing the immunogenicity of two different brands of human Insulin for the treatment of diabetes. - Nil
Spectrum Clinical Research Pvt Ltd0 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入排标准
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.
排除标准
- •1.known hypersensitivity against insulin or any of the inactive components of the formulations
- •2.known extreme resistance to insulin (daily dose of more than 200 IU)
- •3.severe renal failure (NKF stage 4-5) or patients on hemodialysis
- •4.severe cardiac failure (NYHA III-IV)
- •5.myocardial infarction within the last 6 months before
- •randomization
- •6.unstable angina pectoris
- •7.stroke within the last 6 months before randomization
- •8.liver failure with ascites
- •9.severe peripheral vascular disease with ulceration or
- •11.concomitant treatment with corticosteroids (except stable dose of inhaled corticosteroids)
- •12.Concomitant treatment with immunosuppressive agents (e.g. cyclosporine A, methotrexate, etc.)
- •13.concomitant treatment with somatotropine
- •14.pregnancy or lactation period in female patients
- •15.severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol or the evaluation of efficacy or safety
- •16.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)
- •17.participation in another clinical trial within the last 12 weeks
- •18.legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
- •19.Unreliability or lack of cooperation
- •20.Lack of a possibility to attend the visits required by protocol.
研究者
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