ISRCTN05215453已完成不适用
Effect of rosiglitazone, compared to sulphonylurea, on endothelial function in Chinese patients with type two diabetes
Hong Kong University Research Committee (Hong Kong)0 个研究点目标入组 68 人开始时间: 2006年11月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Chinese men and women aged 30 to 70 years
- •2. Type two diabetes (defined by the World Health Organization [WHO] criteria) diagnosed after 30 years of age
- •3. On diet with/without sulphonylurea (less than or equal to half-maximum dose) with/without metformin for at least six months
- •4. No change in anti-diabetic, lipid lowering and anti-hypertensive in preceding 12 weeks
- •5. Body Mass Index (BMI) more than or equal to 23 and less than or equal to 35 kg/m^2
- •6. Systolic blood pressure less than or equal to 160 mmHg and diastolic blood pressure less than or equal to 90 mmHg
- •7. HbA1c levels between 7.5 and 10.5% inclusively (normal less than or equal to 6.1%) on at least two occasions in the past three months
- •8. Female patients must be post-menopausal (i.e. more than six months without menstrual period), surgically sterilised, or using hormonal contraceptives or intrauterine devices
排除标准
- •1. Pregnancy or lactation
- •2. Any clinically significant abnormality identified on the screening physical examination, laboratory tests, or electrocardiogram which, in the judgement of the investigator, would preclude the safe completion of the study
- •3. Use of anti-diabetic drugs other than metformin or sulphonylurea within 12 weeks
- •4. Use of any investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication
- •5. Patients with a documented history of significant hypersensitivity to any drugs including thiazolidinedione and sulphonylurea (e.g., difficulty in swallowing or breathing, or tachycardia)
- •6. Active alcohol or drug abuse within the last six months
- •7. Presence of clinically significant renal or hepatic disease:
- •7.1. Serum creatinine above Upper Normal Range (UNR) (creatinine more than 128 umol/L for males and more than 107 umol/L for females)
- •7.2. Proteinuria more than 1 gm/day
- •7.3. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), total bilirubin, or alkaline phosphatase more than two times above UNR
- •8. Significant anaemia (haemoglobin less than 11 g/dl for males or less than 10 g/dl for females)
- •9. Patients with haemoglobinopathies
- •10. Leukocyte count less than 3.0 x 10^9/L or platelet count less than 120 x 10^9/L
- •11. Patients with severe angina, coronary insufficiency, heart failure (New York Heart Association [NYHA] class III or IV), or history of cardiovascular event in the past six months
- •12. Patients with electrocardiographic evidence of left ventricular hypertrophy based upon the maximal voltage of Sv1 plus the maximal voltage of Rv5 or Rv6 more than 3.5 mV and ST-T segment changes
- •13. Symptomatic diabetic neuropathy of sufficient severity to require treatment for control of symptoms (e.g. painful peripheral neuropathy, symptomatic orthostatic hypotension, urinary retention, pedal ulcers, gastric stasis, etc.)
- •14. Patients with history of psychiatric illness
研究者
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