AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

What Was Tested

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

It had three arms (groups): AT247 (experimental), NovoRapid (active comparator) and Fiasp (active comparator).

The registry classes the interventions as biological.

Who Took Part

The registry lists 18 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 type I Diabetes Mellitus for at least 12 months. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months. BMI 18.5-35.0 kg/m2.

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 95-140 mmhg and/or diastolic bp greater than 90 mmhg.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

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

It started in 2019-04-12 with completion listed for 2019-07-30.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the glucose infusion rate-time curve of insulin aspart (time frame: 0-60 minutes).

It also tracked 1 secondary outcome, for example Area under the serum insulin aspart concentration-time curve from 0-60 minutes.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 18 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.