Changes of the Infusion Rate in Insulin Pump Treatment

NCT00449839 | Completed Phase 4 DMC

• 1 other identifier: PDS 265 PK IAsp 2006/199
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Insulin pump treatment CSII; Absorption; Insulin Aspart

Outcome Measures

Primary Outcomes (1)

• Absorbed Insulin Aspart

  one year

Study Arms (3)

A, CSII without bolus

OTHER

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

B; CSII with bolus

OTHER

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

C; CSII with bolus, optional

OTHER

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

Interventions

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.

Also known as: Insulin Aspart/NovoRapid

A, CSII without bolus; B; CSII with bolus; C; CSII with bolus, optional

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Aarhus University Hospital, department of Endocrinology and Diabetes

Aarhus C, Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jens Sandahl Christiansen, Prof. Dr.Med

  Aarhus University Hospital, department of Endocrinology and Diabetes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 21, 2007
• Study Start: April 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 2, 2009

Record last verified: 2009-06

Locations

DK (1)