Clinical trial NCT00449839: Changes of the Infusion Rate in Insulin Pump Treatment
Official title: Changes of the Infusion Rate in Insulin Pump Treatment. A Randomized, Unblinded Cross-Over Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: Insulin pump treatment CSII
Absorption
Insulin Aspart
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2007-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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. In period B and C will the infusion start with a bolus.

It will be investigated if a steady state of insulin will be obtained faster in period B and C then A.

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. Each period will last 12 hours and blood will be drawn to measure absorbed Insulin Aspart. During period A will a constant the infusion rate of insulin be given. In period B and C will there at the start of the constant infusion rate be given a bolus. The bolus in period C is calculated on the basis of the results in period B, therefore will all participants experience period C last where as period A and B is randomized cross-over. Period C is written in the protocol as optional and it is evaluated after period A and B if period C will be performed.

The hypothesis is that steady state of insulin will be obtained faster in period B and C than A.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Absorbed Insulin Aspart
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital, department of Endocrinology and Diabetes
state: Aarhus
Study officials:
affiliation: Aarhus University Hospital, department of Endocrinology and Diabetes
name: Jens Sandahl Christiansen, Prof. Dr.Med
role: PRINCIPAL_INVESTIGATOR
References: