Einfluß einer supplementären Therapie mit postprandial injiziertem Insulin Lispro (Huma-log®) auf diabetesbezogene Komplikationen und Lebensqualität bei geriatrischen Patienten mit Typ 2 Diabetes

Phase 1

• Conditions: Diabetes

• Registration Number: EUCTR2004-003700-38-DE
• Lead Sponsor: Profil Institut fuer Stoffwechselforschung GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-10-18
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 104

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified