Status:
COMPLETED
Changes of the Infusion Rate in Insulin Pump Treatment
Lead Sponsor:
Aarhus University Hospital
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Diabetes
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
A pharmacokinetic study of insulin pump treatment using Insulin Aspart. The study consist of three different periods A, B and C where a constant the insulin infusion rate is given during the periods. ...
Detailed Description
A pharmacokinetic study of insulin pump treatment using Insulin Aspart. The study consist of three different periods A, B and C where a constant the insulin infusion rate is given during the periods. ...
Eligibility Criteria
Inclusion
- Informed consent
- Healthy volunteer
- Men and women between ≥18 and \<50 years
- Women in the child-bearing age should be sufficient protected against pregnancy (use birth control pill or intrauterine device or be sterilized or hysterectomized)
- BMI between 18-30 kg/m\^2 (both included)
Exclusion
- Suspected or known allergy against the drug used in the study or similar drugs
- Previous history of endocrinology disease (including Diabetes Mellitus)
- Suspected or known alcohol- or drug abuse
- Any disease influencing the study, evaluated by the investigator
- Pregnancy, breast-feeding or the wish of becoming pregnant during the study period. Furthermore women in the child bearing age not sufficient protected against pregnancy (sufficient is: use of birth control pill or intrauterine device or be sterilized or hysterectomized)
- Participation in other research projects during the last 3 months before this project
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00449839
Start Date
April 1 2007
End Date
October 1 2008
Last Update
July 2 2009
Active Locations (1)
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1
Aarhus University Hospital, department of Endocrinology and Diabetes
Aarhus C, Aarhus, Denmark, 8000