Bioavailability of Insulin Administered in Duodenum

What Was Tested

This registered phase 1, phase 2 trial tested Insulin Aspart.

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

The registry classes the interventions as drug.

More on the Plan

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.

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.

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.

Who Took Part

Enrollment: 12 planned participants were the target.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Signed informed consent. Age \>18 - \< 50 years. BMI 18-30 kg/m2.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: any history of gastrointestinal or endocrine disorders (e.g. diabetes mellitus); pregnancy or nursing; suspected or known allergy towards the drug.

How the Study Was Run

Design: non-randomized, single-group and single-blind.

In this single-blind Insulin Aspart study one party knew the assignments and the other did not.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-08 with completion listed for 2006-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To define the bioavailability of a solution of insulin Aspart infused in the Duodenum.

It also tracked 5 secondary outcomes, for example To assess any safety issues and Explore any influence of PH/ insulin concentration on PK /PD parameters.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of Insulin Aspart in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.