EUCTR2007-005744-24-PL进行中（未招募）不适用
A phase IIa, placebo controlled, randomized, cross-over study to evaluate the effects of DM-99 on a meal tolerance test in subjects with type 2 diabetes mellitus
DiaMedica Inc.0 个研究点目标入组 20 人开始时间: 2008年1月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •Diagnosed Type 2 diabetes for no less than 3 months prior to screening
- •HbA1c between 7.5 – 8.9
- •Drug naïve OR stable on no more than one anti-diabetic medication, limited exclusively to either sulfonylureas (SU) or metformin (Met) for a period of at least 8 weeks.
- •Ability to give legal consent
- •A willingness to participate in this study as judged by the subject giving informed consent
- •A willingness to refrain from blood donation within 7 days prior to Visit 1 and throughout the trial
- •A willingness to refrain from alcohol within 24 hours prior to any study visit
- •Agree to follow caffeine restrictions during the study and agree to eat served standard and test meals
- •Age 40-70
- •If females, must be post-menopausal (12 consecutive months amenorrhea) or full oophorectomy (removal of both ovaries)
- •Ability to consume a can of liquid Vanilla Boost within 2 minutes
- •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
- •Use of any investigational drug or device, or participation in any drug study during or within 30 days prior to baseline (Visit 1)
- •Use of ACE inhibitors (refer to Addendum 1 for list of drugs)
- •Use of products containing Nicotine including cigarettes
- •Significant digestive abnormalities such as malabsorption or chronic diarrhea
- •Alcohol or drug abuse within the past year
- •Insulin treatment
- •On Hormone Replacement Therapy
- •Positive HIV or hepatitis (B or C)
- •Body mass index (BMI) > 39 kg/m2
- •Any medical or psychiatric condition which would make the subject unsuitable to participate in a clinical study
- •Any known hypersensitivity or allergy to kallikrein
- •Concomitant use of any product containing kallikrein
- •Any known lactose intolerant or allergic to dairy products
- •Any known hypersensitivity or allergy to agglutinins and/or hemagglutinin
- •Cerebral Vascular Events
- •Intracranial Hypertension
- •Severe Cardiac insufficiency or coronary insufficiency
- •Acute or chronic inflammation of the genitals
研究者
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