EUCTR2004-003700-38-DE进行中(未招募)1 期
Einfluß einer supplementären Therapie mit postprandial injiziertem Insulin Lispro (Huma-log®) auf diabetesbezogene Komplikationen und Lebensqualität bei geriatrischen Patienten mit Typ 2 Diabetes
Profil Institut fuer Stoffwechselforschung GmbH0 个研究点目标入组 104 人开始时间: 2004年10月18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
- 入组人数
- 104
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
入选标准
- •- type 2 diabetes
- •- age 70 years or above
- •- HbA1c 6-12% (inclusive)
- •- insulin therapy with twice daily injections of a premixed insulin for at least 3 months
- •- able to give written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •- significant cardiovascular event (e.g. myocardial infarction, stroke) in the past 6 months
- •- presence of a disease which might influence the study results or involves an additional risk for study participation for the subjects
- •- clinically relevant deviations in lab parameters from normal (e.g. liver enzymes more than threefold above upper limit of normal, serum creatinine higher than 1.7 mg/dl
- •- concomitant medication which might influence the study results (e.g. steroids)
- •- alcohol or drug addiction
- •- inability to understand the informed consent or the study procedures
- •- participation in another trial in the past 4 weeks
研究者
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