Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers

What Was Tested

The trial (phase 1) is built around Insulin Aspart.

It had two arms (groups): insulin glulisine, insulin aspart (active comparator) and insulin aspart, insulin glulisine (active comparator).

Insulin glulisine administration during first glucose clamp, insulin aspart administration during second glucose clamp.

Insulin aspart administration during first euglycemic clamp, insulin glulisine administration during second clamp.

The registry classes the interventions as drug.

More on the Plan

These results were in line with a faster early insulin exposure of insulin glulisine compared to insulin lispro.

The primary aim of this study was to investigate whether or not these favorable characteristics of insulin glulisine were also evident in the comparison against insulin aspart.

This was the first clinical study realizing a head-to-head comparison between these two insulin analogs.

Who Took Part

12 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Between the ages of 18 and 65 years. Body Mass Index of \<= 27 kg/m². Safety lab within reference range. Normal blood pressure and heart rate. Sufficient venous access.

The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: known allergies to insulin or related compounds; regular treatment with any drug, both over-the-counter or prescribed; regular use of drugs of abuse and or positive findings on urinary drug screening.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2007-11 with completion listed for 2007-12.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: fractional and total glucose infusion rates.

It also tracked 1 secondary outcome, for example fractional and total insulin areas under the curve (AUC).

What This Means in Plain Language

Put simply, this is a phase 1, 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.