Bioavailability of Insulin Administered in Duodenum

Diabetes Mellitus Clinical Trial

Official title:

Bioavailability, Pharmacokinetics and Pharmacodynamics of Insulin Aspart Administered in the Duodenum in Healthy Volunteers – an Open Single Blinded and Uncontrolled Explorative Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353990
• Other study ID #: 2006-002803-15
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 18, 2006
• Last updated: April 24, 2007
• Start date: August 2006
• Est. completion date: December 2006

Study information

• Verified date: April 2007
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Insulin Aspart

Locations

Country	Name	City	State
Denmark	Medical Department M	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define the bioavailability of a solution of insulin Aspart infused in the Duodenum
Secondary	Evaluate pharmacokinetics of insulin following duodenal administration
Secondary	Evaluate intra- and intersubjects variation in pharmacokinetic
Secondary	Evaluate pharmacodynamics of insulin
Secondary	To assess any safety issues
Secondary	Explore any influence of PH/ insulin concentration on PK /PD parameters