A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

It had 1 arm (groups): Insulin therapy (experimental).

Insulin Aspart, Biphasic Insulin Aspart 70 and 50 \& Fast-acting Human Insulin.

The registry classes the interventions as drug.

More on the Plan

This trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of IAsp, BIAsp 50, BIAsp 70 and Fast-acting Human Insulin after a standard test meal in subjects with type 1 diabetes.

The trial consists of a screening period of 4-21 days and 4 treatment visits.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis. Insulin treatment of any regime for more than one year at time of inclusion. Age ≥ 18 years. BMI between 18 and 35 kg /m2 (including both values).

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products; recurrent major hypoglycaemic episodes; heart: unstable angina pectoris, ami \< 12 months or heart insufficiency classified according to nyha iii-iv.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2009-06 with completion listed for 2010-06.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between fast-acting human insulin vs. IAsp, BIAsp 50 and BIAsp 70, IAsp vs BIAsp 50 and BIAsp 70, BIAsp 50 vs. BIAsp 70 (time frame: 12 hours following a standard test meal (breakfast)).

It also tracked 4 secondary outcomes, for example tmaxins: Time to maximum serum insulin aspart/human insulin concentration and Serum GH, total IGF-I, IGF-I bioactivity, IGFBP-1, IGFBP-2, binary complex of IGF-I, IGFBP-3 and the acid-labile subunit (ALS).

What This Means in Plain Language

Put simply, this is a phase 3, 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.