Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

What Was Tested

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

This trial is conducted in Africa.

It had two arms (groups): U100 (active comparator) and U200 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 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. Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant. Body mass index (BMI) 18-26 kg/m\^2 (both inclusive). Weight 60-90 kg.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: any condition requiring the regular use of any medication; known or suspected allergy to the trial product or related products; family history of type 1 diabetes mellitus.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant and investigator.

It started in 2002-09-02 with completion listed for 2002-10-18.

It ran at 1 site in South Africa.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the curve (AUC). Area under the glucose infusion rate curve.

It also tracked 6 secondary outcomes, for example Cmax (maximum plasma concentration), Time to reach maximum (tmax), Terminal half-life (t½), Incidence of hypoglycemic events, Adverse events and GIRmax: The maximal GIR (glucose infusion rate).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 24 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.