Bioavailability, Pharmacokinetics and Pharmacodynamics of Insulin Aspart following Subcutaneous Insulin Infusion (CSII) - Basal Rate Resolution.
- Conditions
- Type 1 diabetes mellitusContinious subcutaneous insulin infusion (CSII)MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2007-001912-21-DK
- Lead Sponsor
- Aarhus Sygehus, Universityhospital of Aarhus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Type 1 diabetes mellitus (T1DM)
- Insulin pump users’ = 48 hours, 24 h dose < 80 U
- Insulin dose = 0,5 IE/kg/24hours
- 18 years < age < 50 years
- Time since diagnosis of T1DM = 5 years
- HbA1c = 8,5 %
- Safe anticonception for fertile women
- Being able to understand and read Danish
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Dysregulation of endocrine disorders other than type 1 diabetes mellitus
- Severe dysregulation of diabetes mellitus
- Other severe adverse disease
- Pregnancy, planning pregnancy, or nursing
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To define the bioavaliability, pharmacokinetics, and pharmacodynamics of insulin aspart following subcutaneous insulin infusion (CSII)- definition of basal rate resolution.;Secondary Objective: ;Primary end point(s): Primary endpoint:<br>- Coefficient of variation of steadystate plasma insulin aspart<br><br>Secondary endpoints:<br>- Bioavaliability of plasma insulin aspart under steadystate (AUC)<br>- Bioequivalence of insulin aspart under steadystate (GIR, S-FFA, S-glycerol)<br>
- Secondary Outcome Measures
Name Time Method