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Bioavailability of Insulin Administered in Duodenum

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ClinicalTrials.gov Identifier: NCT00353990
Recruitment Status : Completed
First Posted : July 19, 2006
Last Update Posted : April 25, 2007
Aarhus University Hospital
Information provided by:
University of Aarhus

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Insulin Aspart Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
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
Study Start Date : August 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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

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

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): NCT00353990

Medical Department M
Aarhus, Denmark, DK-8000 C
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
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

ClinicalTrials.gov Identifier: NCT00353990     History of Changes
Other Study ID Numbers: 2006-002803-15
First Posted: July 19, 2006    Key Record Dates
Last Update Posted: April 25, 2007
Last Verified: April 2007

Keywords provided by University of Aarhus:

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