Changes of the Infusion Rate in Insulin Pump Treatment
Changes of the Infusion Rate in Insulin Pump Treatment. A Randomized, Unblinded Cross-Over Study.
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Aarhus
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Aarhus C, Aarhus, Denmark, 8000
- Aarhus University Hospital, Department of Endocrinology and Diabetes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: A, CSII without bolus
Period A: A constant subcutaneous infusion rate of insulin aspart (0.5 U/hr) is given for 8 hours.
Following 3 hours of blood sampling.
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A; CSII without bolus: 8 hours of constant insulin infusion. B; CSII with bolus: 8 hours of a constant insulin infusion starting with a s.c. bolus. C; CSII with bolus, optional: 8 hours of a constant insulin infusion starting with a different bolus than period B. This period is optional and it will be evaluated after period A and B if period C is conducted.
Other Names:
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Other: B; CSII with bolus
Period B: A constant subcutaneous infusion of insulin aspart (0.5 U/hr) is given for 8 hours and upon start a s.c.bolus (1.4 U)of insulin aspart is given.
Hereafter follows 3 hours of blood sampling.
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A; CSII without bolus: 8 hours of constant insulin infusion. B; CSII with bolus: 8 hours of a constant insulin infusion starting with a s.c. bolus. C; CSII with bolus, optional: 8 hours of a constant insulin infusion starting with a different bolus than period B. This period is optional and it will be evaluated after period A and B if period C is conducted.
Other Names:
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Other: C; CSII with bolus, optional
A constant subcutaneous insulin aspart infusion is given for 8 hours and upon start a bolus of insulin aspart is given.
The bolus in arm C is of a different size then arm B. After the 8 hours of constant infusion follows 3 hours of blood sampling.
Period C are optional and it is evaluated if it will be conducted after period A and B has been performed.
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A; CSII without bolus: 8 hours of constant insulin infusion. B; CSII with bolus: 8 hours of a constant insulin infusion starting with a s.c. bolus. C; CSII with bolus, optional: 8 hours of a constant insulin infusion starting with a different bolus than period B. This period is optional and it will be evaluated after period A and B if period C is conducted.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Absorbed Insulin Aspart
Time Frame: one year
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one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jens Sandahl Christiansen, Prof. Dr.Med, Aarhus University Hospital, Department of Endocrinology and Diabetes
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDS 265 PK IAsp 2006/199
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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