AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study

What Was Tested

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

Participants and Investigators will be blinded to both study interventions.

Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 41 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening. BMI within the range of 25 - 45 kg/m2 (both inclusive).

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: known or suspected hypersensitivity to imps or related products.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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, care provider, investigator and outcomes assessor.

It started in 2023-02-27 with completion listed for 2024-01-18.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the glucose infusion rate-time curve of insulin aspart (time frame: 0 to 60 minutes).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Insulin Aspart in 41 people.

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.