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Changes of the Infusion Rate in Insulin Pump Treatment

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ClinicalTrials.gov Identifier: NCT00449839
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : July 2, 2009
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Diabetes Drug: Insulin Aspart Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes of the Infusion Rate in Insulin Pump Treatment. A Randomized, Unblinded Cross-Over Study.
Study Start Date : April 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

Other Name: Insulin Aspart/NovoRapid

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.
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.

Other Name: Insulin Aspart/NovoRapid

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.
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.

Other Name: Insulin Aspart/NovoRapid




Primary Outcome Measures :
  1. Absorbed Insulin Aspart [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449839


Locations
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Denmark
Aarhus University Hospital, department of Endocrinology and Diabetes
Aarhus C, Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
Novo Nordisk A/S
Investigators
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Principal Investigator: Jens Sandahl Christiansen, Prof. Dr.Med Aarhus University Hospital, department of Endocrinology and Diabetes

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Responsible Party: Jens Sandahl Christiansen, Prof.Dr.Med, Aarhus University Hospital, department of Endocrinology and Diabetes
ClinicalTrials.gov Identifier: NCT00449839     History of Changes
Other Study ID Numbers: PDS 265 PK IAsp 2006/199
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: June 2009
Keywords provided by University of Aarhus:
Insulin pump treatment CSII
Absorption
Insulin Aspart
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs