EUCTR2007-000594-29-GB进行中（未招募）1 期
The use of glycaemic response to sulphonylureas as a tool to investigate Type 2 diabetes pathophysiology - Variation in sulphonylurea response in Type 2 diabetes
HS Tayside0 个研究点开始时间: 2007年2月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Type 2 diabetes
- •Age >35 and < 70
- •Age of diabetes diagnosis >35 and <70
- •White European
- •Pre-SU HbA1c <=10%
- •HbA1c (on treatment) <= 9%
- •No established cardiovascular disease (previous established angina or myocardial infarction)
- •No established cerebrovascular disease (previous stroke or transient ischaemic attack)
- •No or stable (background) retinopathy (no unscheduled laser treatment in the last 6 months)
- •eGFR > 60mls/min
- •No frank proteinuria (on multistix 10SG)
- •No active foot ulceration or infection
- •Liver ALT within the laboratory reference range
- •Contactable by telephone
- •Age >35 and < 70
- •Age of diabetes diagnosis >35 and <70
- •White European
- •HbA1c = 7% and = 9%
- •Not on SU and no previous SU intolerance
- •No established cardiovascular disease (previous established angina or myocardial infarction)
- •No established cerebrovascular disease (previous stroke or transient ischaemic attack)
- •No or stable (background) retinopathy (no unscheduled laser treatment in the last 6 months)
- •eGFR > 60 ml/min
- •No frank proteinuria (on multistix 10SG)
- •No active foot ulceration or infection
- •Liver ALT within the laboratory reference range
- •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 >10% prior to commencing SU
- •HbA1c>9% on SU treatment
- •Previous cardiovascular or cerebrovascular disease
- •Pre-proliferative or proliferative retinopathy
- •eGFR<60 ml/min
- •Proteinuria (multistix 10 SG)
- •Active foot ulceration or infection
- •Liver ALT outwith the reference range
- •Female planning to conceive within the study period
- •Any other significant medical reason for exclusion as determined by the investigator
- •Type 1 diabetes
- •HbA1c = 7% or = 9%.
- •Previous cardiovascular or cerebrovascular disease
- •Pre-proliferative or proliferative retinopathy
- •eGFR< 60 ml/min
- •Proteinuria (multistix 10 SG)
- •Active foot ulceration or infection
- •Liver ALT outwith the reference range
- •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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