EUCTR2007-004837-41-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-83 on a meal tolerance test in subjects with type 2 diabetes mellitus
DiaMedica Inc.0 个研究点开始时间: 2007年10月15日最近更新:
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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
- •The following criteria must be met for a subject to be entered into the study
- •Diagnosed Type 2 diabetes for no less than 3 months prior to screening
- •HbA1c between 7.5 – 8.9
- •Drug naïve OR 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 standardized meals
- •Age 40-70
- •If female, must be post-menopausal (12 consecutive months amenorrhea) or full oophorectomy (removal of both ovaries)
- •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
- •A subject with any of the following complications will be excluded from the study. The exclusion criteria must be assessed prior to entering the subject to the active study period.
- •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 any nitric oxide donating medications (refer to Addendum 1 for list of drugs)
- •Significant digestive abnormalities such as malabsorption or chronic diarrhea
- •Significant organ malfunction including (but not limited to): liver disease (2.5 x normal upper limit), pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease, vasomotor instability, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, epilepsy and parkinsonism, other serious or chronic illness or history of serious or chronic illness
- •Any significant complications from diabetes such as: kidney damage (renal insufficiency, serum creatinine greater than 2mg/dL or 176.8 µmol/L), eye damage (proliferative retinopathy), diabetic neuropathy, coronary artery disease, or peripheral vascular disease.
- •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 acetyl cysteine
- •Concomitant use of any product containing acetyl cysteine or molsidomine
- •Any known hypersensitivity or allergy to molsidomine.
- •Subjects must not be lactose intolerant or allergic to dairy products
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