Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses

What Was Tested

This registered phase 1 trial tested Insulin (regular human) and Insulin Aspart.

It had six arms (groups): 1 (experimental), 2 (experimental), 3 (experimental), 4 (active comparator) and 5 (active comparator).

The registry classes the interventions as drug.

More on the Plan

Double-blind, randomized, 6-period cross-over study in 16 healthy subjects.

Each patient participates in 6 euglycemic glucose clamp experiments each.

The time interval between the study days is 2 to 28 days.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Signed informed consent obtained before any trial-related activities. Healthy subjects between 18 and 45 years inclusive. Considered generally healthy upon completion of medical history and physical examination. Body mass index (BMI) \< 27 kg/m2. Non-smoker for at least three months.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: participation in any other clinical trial and receipt of any investigational drug within four weeks prior to this trial; previous participation in this trial; any disease requiring use of non topical prescription medicines.

How the Study Was Run

Design: randomized, crossover and double-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2002-04 with completion listed for 2002-06.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUC GIR 360-720 min.

It also tracked 2 secondary outcomes, for example PK endpoints such as C max/ins, t max/ins, AUC ins 0-120 min, AUC ins 360-720 min, AUC ins 0-720 min.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Insulin Aspart in 16 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 (regular human) compound page and the Insulin Aspart compound page, all human trials.