EUCTR2008-001670-32-DE
进行中（未招募）
不适用
A Single-Center, Double Blind Study Evaluating the Bioequivalence of the Pharmacokinetic and Pharmacodynamic Properties of Different Formulations of VIAject™ in Subjects with Type 1 Diabetes Mellitus
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Biodel Inc.
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Age: \=19 to \= 65 years
- •2\. Body Mass Index: \= 18 \- \= 28 kg/m2
- •3\. Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
- •4\. Insulin antibody less than or equal to 10 uU/ml at screening
- •5\. Non\-smoker, defined as no nicotine consumption for at least one year.
- •6\. Signed and dated informed consent obtained before any trial\-related activities. (Trial\-related activities are any procedure that would not have been performed during normal management of the subject.).
- •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
排除标准
- •1\. Type 2 Diabetes Mellitus
- •2\. C\-peptide value of \> 1\.0 ng/ml
- •3\. HbA1c value of \> 10\.0%
- •4\. History of hypersensitivity to any of the components in the study medication
- •5\. History of severe or multiple allergies
- •6\. Treatment with any other investigational drug in the last 3 months before study entry
- •7\. Any systemic treatment with drugs known to interfere with glucose metabolism such as systemic corticoids, non\-selective beta\-blockers, and monoamine oxidase (MAO) inhibitors within 3 months prior to randomization.
- •8\. Changes (type of drug or dose) in concomitant medication other than insulin in the last 3 weeks prior to randomization.
- •9\. Use of non\-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of paracetamol/acetaminophen is permitted.
- •10\. Progressive disease likely to prove fatal (e.g. malignancies)
结局指标
主要结局
未指定
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