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临床试验/EUCTR2004-003700-38-DE
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

发起方
Profil Institut fuer Stoffwechselforschung GmbH

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