AT278 and NovoRapid® in Glucose Clamp Study

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Aspart.

It had two arms (groups): AT278 (experimental) and NovoRapid (active comparator).

The registry classes the interventions as drug.

Who Took Part

38 actual participants took part.

It was open to men only aged from 18 years up to 64 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of type 1 diabetes for at least 12 months. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months. Weight within the range 75kg - 100kg (both inclusive).

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: known or suspected hypersensitivity to investigational medicinal products; supine systolic bp outside range 95-140mmhg and/or diastolic bp greater than 90mmhg.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Because people in this Insulin Aspart 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 Aspart and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-12-02 with completion listed for 2021-06-03.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the glucose infusion-rate curve of insulin aspart (time frame: 0 - 8 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 38 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.