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Completed

NCT Number: NCT00449839

Changes of the Infusion Rate in Insulin Pump Treatment

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital, department of Endocrinology and Diabetes

Aarhus C, Aarhus, 8000, Denmark

About this 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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin aspart

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.

Other names: Insulin Aspart/NovoRapid

Primary outcomes

  1. Absorbed Insulin Aspart

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 21, 2007
Registry last updated
Jul 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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