Bioavailability of Insulin Administered in Duodenum

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00353990
First received: July 18, 2006
Last updated: April 24, 2007
Last verified: April 2007
  Purpose

A study of the bioavailability of insulin after infusion in the duodenum in healthy volunteers.


Condition Intervention Phase
Diabetes Mellitus
Drug: Insulin Aspart
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Bioavailability, Pharmacokinetics and Pharmacodynamics of Insulin Aspart Administered in the Duodenum in Healthy Volunteers – an Open Single Blinded and Uncontrolled Explorative Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • To define the bioavailability of a solution of insulin Aspart infused in the Duodenum

Secondary Outcome Measures:
  • Evaluate pharmacokinetics of insulin following duodenal administration
  • Evaluate intra- and intersubjects variation in pharmacokinetic
  • Evaluate pharmacodynamics of insulin
  • To assess any safety issues
  • Explore any influence of PH/ insulin concentration on PK /PD parameters

Estimated Enrollment: 12
Study Start Date: August 2006
Study Completion Date: December 2006
Detailed Description:

METHODOLOGY All subjects will be admitted fasting to the Clinical Trial Unit at Århus Community Hospital at 8 a.m. A Gastrointestinal tube will be placed in Duodenum distal to papilla Vaterii with a pH of approximately 7.0 as measured by the pH meter distal in the tube. An indwelling catheter for glucose infusion (20 %) in cases of hypoglycaemia will be placed in an antecubital vein. In the contralateral anticubital vein a catheter will be placed for blood sampling. All subjects will have 4 tests with duodenal infusion of the insulin Aspart solution. The first 4 volunteers will receive 4 doses of insulin Aspart solution in 1 ml (150, 300, 600 and 1000 IU) with 3-6 hours apart. Blood sampling for Insulin Aspart, total insulin, and glucose (Beckmann apparatus) will be done every 10 minutes the first two hours, and then every 20 minutes. When final the subjects will receive a meal before leaving the hospital.

Based on data from the pilot a dose will be determined for the remaining 8 subjects. These will then based again on results from the pilot on two separate study days receive 4 infusions with 3-6 hours split. Two infusions will be at pH 7 and two infusions will be more proximal at a pH of 5.5 (two different insulin concentrations but the same dose given at the two places in Duodenum). Frequency and interval of blood sampling in the second part will be determined by results from the pilot study. For comparison with the clinical situation and estimation of bioavailability all subjects will receive a subcutaneous and an intravenous (iv) bolus injection of 6 IU of insulin Aspart. The iv injection will be followed by blood sampling for three hours as above, but every 5 minutes the first two hours, and the sc injection will be followed by blood sampling for three hours as above, but again with 10 minutes interval the first two hours.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Healthy Volunteers
  • Age >18 - < 50 years
  • BMI 18-30 kg/m2

Exclusion Criteria:

  • Any history of gastrointestinal or endocrine disorders (e.g. diabetes mellitus)
  • pregnancy or nursing
  • suspected or known allergy towards the drug
  • Participation in other research trials within 3 months before the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353990

Locations
Denmark
Medical Department M
Aarhus, Denmark, DK-8000 C
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Torben Laursen, MD, DMSc, Ph.D. Department of Clinical Pharmacology, Aarhus Sygehus
Principal Investigator: Charlotte A Ihlo, MD Department of Endocrinilogy, Universityhospital of Aarhus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00353990     History of Changes
Other Study ID Numbers: 2006-002803-15
Study First Received: July 18, 2006
Last Updated: April 24, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
insulin
bioavailability
duodenum
infusion
healthy
diabetes
absorption

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014