EUCTR2005-000872-41-HU进行中（未招募）不适用
RANDOMIZED DOUBLE-BLIND, MULTIPLE DOSE, PLACEBO-CONTROLLED STUDY TO DETERMINE THE INSULIN SENSITIZING EFFECT OF BGP-15 IN PATIENTS WITH INSULIN RESISTANCE - THE INSULIN SENSITIZING EFFECT OF BGP-15
-Gene Research & Development Ltd.0 个研究点开始时间: 2005年2月25日最近更新:
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
- •Male and female patients, 25-60 years (females only if being /hysterectomised/ surgically sterilized)
- •Altered glucose metabolism with insulin resistance
- •IFG patients: Fasting blood sugar >6.1 mmol/l and less than 7.0 mmol/l, OR
- •IGT patients: Fasting blood sugar =7.0 and 2 hour blood sugar during OGTT is <11.1 mmol/ AND
- •Insulin resistance should be confirmed with the HOMA–IR test (higher than 2.5)
- •Abdominal obesity: waist-to-hip ratio >0.90 in men or >0.85 in women, or BMI >27
- •Written informed consent
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Type-I diabetes mellitus
- •Drug-treated type II diabetes mellitus
- •Uncontrolled hypertension (systolic BP >160 mmHg; diastolic BP >95 mmHg). Patients with stable antihypertensive therapy (no change in drug dosage during 6 months before the study start ) can be enrolled.
- •Ischaemic heart disease requiring nitrate therapy
- •Heart failure (NYHA III or IV) or having being admitted for heart failure exacerbation in the last 3 months
- •Malabsorption, gastro-intestinal bypass, acute or chronic pancreatitis
- •ALT >2.5 times the upper limit of the normal
- •Serum creatinine >135 µmol/l
- •Clinically significant anemia (hematocrit <30%)
- •Active inflammatory disease
- •History of cancer in the last 5 years (except skin basal cell carcinoma)
- •Lactation, pregnancy or birth control with hormones
- •Alcohol or drug abuse (in the last 2 years)
- •Other significant organ system illness or condition (including psychiatric, cardiac, endocrine) requiring drug treatment with medications with known metabolic effects.
- •Gastroenterological, urogenital, respiratory, musculoskeletal and immunological disorders
- •Hypersensitivity to nicotinic acid
- •Participation in a clinical trial within 3 months before start of the trial
研究者
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