EUCTR2008-004790-18-GB进行中（未招募）不适用
Response to Oral Agents in Diabetes (ROAD) Pilot Study - ROAD study pilot
niversity of Dundee0 个研究点开始时间: 2008年9月4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
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
- •Cohort 1. Commencing Metformin
- •Type 2 diabetes diagnosed more than 6 weeks prior to visit 1
- •GP considers adequate diet and lifestyle advice given
- •Age >35 and < 80
- •Age of diabetes diagnosis >35
- •White European
- •HbA1c >7% & <=9%
- •eGFR>=50 ml/min
- •ALT <= 2.5*ULN
- •Contactable by telephone
- •Cohort 2 - randomised to second line therapy
- •Type 2 diabetes
- •Treated with metformin for more than 3 months; or metformin intolerant
- •Age >35 and < 80
- •Age of diabetes diagnosis >35
- •White European
- •HbA1c >7% & <=9%
- •eGFR>=50 ml/min
- •ALT <= 2.5*ULN
- •No previous history of heart failure; No patients with documented evidence of left ventricular systolic dysfunction OR with symptoms and signs consistent with a clinical diagnosis of heart failure
- •No treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
- •No osteoporosis
- •Contactable by telephone
- •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
- •Type 1 diabetes
- •HbA1c >9% or <=7%
- •eGFR<50 ml/min
- •ALT > 2.5*ULN
- •Alcohol consumption in excess of 50 units per week
- •Female planning to conceive within the study period
- •Any other significant medical reason for exclusion as determined by the investigator
- •Cohort 2. Randomised to second line therapy
- •Type 1 diabetes
- •HbA1c >9% or <=7%
- •eGFR< 50 ml/min
- •ALT > 2.5*ULN
- •Previous history of heart failure OR documented evidence of left ventricular systolic dysfunction OR symptoms and signs consistent with a clinical diagnosis of heart failure
- •Ongoing treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
- •Previous diagnosis of osteoporosis
- •Pregnant female or female planning to conceive within the study period
- •Any other significant medical reason for exclusion as determined by the investigator
研究者
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