Comparison of the impact of biphasic insulin aspart 30(BiAsp30), biphasic insulin aspart 70 (BiAsp 70) and insulin aspart on postprandial glucose and lipid metabolism during two consecutive meals in type 2 diabetics.
Phase 1
- Conditions
- Diabetes mellitus Typ IIMedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2008-008486-35-AT
- Lead Sponsor
- Medizinische Universität Graz, Klinische Abteilung für Endokrinologie und Nuklearmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Type 2 Diabetes mellitus
BMI > 27 kg/m2
Treatment with premixed insulin once or twice daily ± Metformin
stable insulin dose in the last 4 weeks
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 > 8.5 %
Serum creatinine > 1.7 mg/dl
ALT or AST > 3x ULN
Treatment with sulfonylurea, DPP-IV-inhibitors or glitazones
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the impact of 3 insulin preparations on postprandial glucose and lipid metabolism in two consecutive meals in patients with type 2 diabetes.;Secondary Objective: n.a.;Primary end point(s): AUC for postprandial glucose for each meal and both together<br>AUC for postprandial triglycerides for each meals and both together
- Secondary Outcome Measures
Name Time Method