Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human).

This trial is conducted in Europe.

It had two arms (groups): NN729 manufacturing process (experimental) and Current manufacturing process (active comparator).

The registry classes the interventions as drug.

Who Took Part

28 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant. Body Mass Index (BMI) 22.0-27.0 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: participated in another clinical study with an investigational drug within the last 4 weeks; any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. occasional paracetamol is acceptable; known or suspected allergy to the trial product or related products.

How the Study Was Run

The set-up was 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 2002-10-15 with completion listed for 2002-12-20.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): AUC (area under the curve) 0-8h (human insulin). Cmax (maximum plasma concentration). Area under the curve (glucose infusion rate (GIR)), 0-8h.

It also tracked 6 secondary outcomes, for example tmax (time to reach maximum), t½ (terminal half-life), GIR (glucose infusion rate) max, tGIR (glucose infusion rate) max, Area under the curve (C-peptide, 0-8h) and Physical examinations and vital signs.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 28 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, all human trials.