EUCTR2005-004753-95-GB进行中（未招募）1 期
A Phase II, Dose Ranging Single Centre, Single Blind, Parallel-group, Controlled Study of the Safety, Tolerability and Effects on Metabolic Control of an Oral Insulin Formulation in a Type II Diabetic Population - Oral insulin, type II diabetes, isoglycaemic clamp
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
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
入选标准
- •Male or Female.
- •Aged between 18-65 years (inclusive).
- •A BMI of 18-35.
- •Signed informed consent.
- •A confirmed medical history of Type II Diabetes.
- •Without major organ pathology(e.g. cardiac, immunological psychiatric, endocrine or neurological disorders, cancer or other wasting diseases- (adequately treated actinic keratosis, or basal cell carcinoma (BCC) or carcinoma in situ (CIS) of the cervix are permitted.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Presence of any clinically significant medical condition as determined by the investigator.
- •Medically significant hypersensitivity or idiosyncratic reaction related to any medicinal product including vaccines.
- •History or evidence of drug abuse 1 year prior to enrolment.
- •Participation in a clinical study if an investigational product within 3 months prior to the start of the study.
- •History or suspicon of inability to comply with the clinical study protocol.
- •Immunodefiency or clinically autoimmune disease.
研究者
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