Changes of the Infusion Rate in Insulin Pump Treatment

Diabetes Clinical Trial

Official title:

Changes of the Infusion Rate in Insulin Pump Treatment. A Randomized, Unblinded Cross-Over Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449839
• Other study ID #: PDS 265 PK IAsp 2006/199
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2007
• Last updated: June 30, 2009
• Start date: April 2007
• Est. completion date: October 2008

Study information

• Verified date: June 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Insulin Aspart
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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, department of Endocrinology and Diabetes	Aarhus C	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absorbed Insulin Aspart		one year	No