Vergleich der Effektivität von Insulin Aspart und Normalinsulin bei Typ 2 Diabetikern hinsichtlich des postprandialen Stoffwechsels während zwei aufeinanderfolgender Mahlzeiten. Die Huckepack Studie
Phase 1
- Conditions
- Type-2 Diabetes treated with insulin
- Registration Number
- EUCTR2004-002455-13-AT
- Lead Sponsor
- Dept. of Internal Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
Typ 2 Diabetes
BMI > 27 kg/m2
Treatment with insulin alone or in combination with metformin
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
Exclusion Criteria
HbA1c > 9.5 %
Serum Kreatinin > 1.7 mg/dl
ALT or AST > 3x ULN
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Investigate whether NovoRapid or Actrapid exert different effects on postprandial lipid and glucose metabolism during 2 consecutive meals.;Secondary Objective: N.A.;Primary end point(s): glucose area over basal for each single meal and combined<br>triglyceride area over basal for each single meal and combined
- Secondary Outcome Measures
Name Time Method