NCT00353990

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 diabetes-mellitus

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2006

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

April 25, 2007

Status Verified

April 1, 2007

First QC Date

July 18, 2006

Last Update Submit

April 24, 2007

Conditions

Diabetes Mellitus

Keywords

insulinbioavailabilityduodenuminfusionhealthydiabetesabsorption

Outcome Measures

Primary Outcomes (1)

  • To define the bioavailability of a solution of insulin Aspart infused in the Duodenum

Secondary Outcomes (5)

  • 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

Interventions

Insulin AspartDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Department M

Aarhus, Aarhus, DK-8000 C, Denmark

Location

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Torben Laursen, MD, DMSc, Ph.D.

    Department of Clinical Pharmacology, Aarhus Sygehus

    PRINCIPAL INVESTIGATOR

  • Charlotte A Ihlo, MD

    Department of Endocrinilogy, Universityhospital of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 19, 2006

Study Start

August 1, 2006

Study Completion

December 1, 2006

Last Updated

April 25, 2007

Record last verified: 2007-04

Locations

DK(1)