EUCTR2014-003716-36-DE进行中（未招募）1 期
A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Overweight and Obese Subjects with a History of Type 2 Diabetes Mellitus
MedImmune Limited, a wholly owned subsidiary of AstraZeneca0 个研究点目标入组 107 人开始时间: 2014年12月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 107
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
- •-Male or female age 18-65
- •-Must provide written informed consent
- •-Body mass index 27 to 40 kg/m2
- •-Vital signs within normal specified ranges
- •-Diagnosis of T2DM and glucose control managed with metformin monotherapy where no significant dose change has occurred in the 3 months prior to screening.
- •-Venous access suitable for multiple cannulations.
- •-For subjects in Cohort 4, 5 and 6: Willing and able to self-administer daily SC injections.
- •-Females must be non-lactating and non-childbearing potential
- •-Males must practice 2 effective contraceptive measures if sexually active
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •-Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- •-History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- •-History of cancer within the last 10 years, with the exception of non-melanoma skin cancer
- •-History or presence of diabetic foot ulcers
- •-Any clinically important illness (apart from T2DM for subjects with known diabetes), medical/ surgical procedure, or trauma within 4 weeks prior to Day 1 dosing.
- •-Symptoms of insulinopenia or poor blood glucose control
- •- Fasting blood glucose = 200 mg/dL
- •-Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening.
- •-Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
- •-Known or suspected history of alcohol or drug abuse within the past 3 years. Positive drug screen.
研究者
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