EUCTR2007-002060-10-DE进行中（未招募）不适用
Pharmacokinetics and Pharmacodynamics of subcutaneous applied insulin aspart administered with the FlexPen® insulin pen compared to inhaled insulinadministered with the Exubera® device
ikfe GmbH0 个研究点开始时间: 2007年5月31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
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. Informed consent obtained before conduct of any study-related activities (a
- •study related activity is any procedure that would not have been performed
- •during normal clinical management of the patient)
- •2. Patients with diabetes mellitus type 1 or type 2
- •3. Male or female, aged = 18 years (only patients with type 1 diabetes); male
- •or female aged = 45 years (only patients with type 2 diabetes)
- •4. Pharmacological antidiabetic treatment with at least two oral antidiabetic
- •drugs for at least 2 years (only for type 2 diabetic patients)
- •5. Type 1 and type 2 diabetes duration = 2 years
- •6. HbA1c in between and including the values of 6.6 and 10.9%.
- •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. History of known hypersensitivity to any of the components in the study
- •2. Use of tobacco within the last 6 months
- •3. History of severe or multiple allergies
- •4. Treatment with any other investigational drug within the last 30 days before
- •study entry
- •5. Progressive disease likely to prove fatal
- •6. History of malignant disease within the past 5 years
- •7. History of drug / alcohol abuse within the past 5 years
- •8. A woman who is breast feeding
- •9. Pregnant women or women intending to become pregnant during the study
- •10. A sexually active woman of childbearing potential not actively and
- •consistently practicing birth control by using a medically accepted device or
- •11. History of use of insulin for a consecutive period of at least 5 days (only for
- •patients with type 2 diabetes)
- •12. Severe neuropathy, visual impairment and/or motor disabilities as judged
- •by the investigator
- •13. Mental or physical incapacity, unwillingness or language barriers
- •precluding adequate understanding or co-operation
- •14. A history of lack of compliance with medical instructions
- •15. Clinically significant physical or laboratory findings excluding the patient
- •from the study participation as judged by the investigator
研究者
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