Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

This trial is conducted in Europe.

The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.

It had two arms (groups): NN2000 (experimental) and IAsp (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 were not accepted; participants needed the condition being studied.

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 5 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

Design: randomized, crossover and double-blind.

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 2003-01-19 with completion listed for 2003-02-24.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the Curve (AUC) (insulin aspart).

It also tracked 4 secondary outcomes, for example Cmax (maximum plasma concentration), Terminal half life (t½), Incident of hypoglycaemic episodes and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart 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 Aspart compound page, all human trials.