Changes of the Infusion Rate in Insulin Pump Treatment

NCT ID: NCT00449839

Last Updated: 2009-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-10-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Insulin Aspart

Intervention Type: DRUG

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.

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.

Group Type: OTHER

Insulin Aspart

Intervention Type: DRUG

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.

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.

Group Type: OTHER

Insulin Aspart

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Insulin Aspart/NovoRapid

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aarhus University Hospital, department of Endocrinology and Diabetes

Principal Investigators

Jens Sandahl Christiansen, Prof. Dr.Med

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital, department of Endocrinology and Diabetes

Locations

Aarhus University Hospital, department of Endocrinology and Diabetes

Aarhus C, Aarhus, Denmark

Countries

Denmark

Other Identifiers

PDS 265 PK IAsp 2006/199

Identifier Type: -

Identifier Source: org_study_id