Bioequivalence Between Two Explorative Insulin Degludec Formulations and Between Two Explorative IDegAsp Formulations in Healthy Subjects

What Was Tested

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

This trial is conducted i Europe.

The aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without buffer, in healthy male subjects.

The investigated formulations are explorative, not similar to the proposed commercial formulation.

It had two arms (groups): insulin degludec (experimental) and IDegAsp (experimental).

The registry classes the interventions as drug.

Who Took Part

58 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Informed consent obtained before any trial-related activities. Trial related activities are any procedure that would not have been performed during the normal management of the subject. Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator. Body mass index (BMI) between 18.0 and 27.0 kg/m\^2 (inclusive).

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: known or suspected allergy to trial products or related products.

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.

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 and investigator.

It started in 2008-05 with completion listed for 2008-08.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the serum insulin degludec concentration-time curve (for insulin degludec). Maximum serum insulin degludec concentration (Cmax) (for insulin degludec). Area under the serum insulin aspart concentration-time curve (for IDegAsp).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 58 people.

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.