Changes of the Infusion Rate in Insulin Pump Treatment

Aarhus University Hospital

Status and phase: Completed; Phase 4

Conditions: Diabetes

Treatments: Drug: Insulin Aspart

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00449839

PDS 265 PK IAsp 2006/199

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

A, CSII without bolus

Other group

Description:

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.

Treatment:

Drug: Insulin Aspart

B; CSII with bolus

Other group

Description:

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.

Treatment:

Drug: Insulin Aspart

C; CSII with bolus, optional

Other group

Description:

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.

Treatment:

Drug: Insulin Aspart