A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.

What Was Tested

The trial (not phased) is built around Insulin Aspart.

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 30, BIAsp 50 and BIAsp 70 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

24 planned participants were the target.

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 9 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.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2006-01 with completion listed for 2006-08.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Primary endpoint:. • Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between BIAsp 50 vs BIAsp 70, BIAsp 30 vs BIAsp 70, BIAsp 30 vs BIAsp 50 and IAsp vs BIAsp 30, 50 and 70.

It also tracked 3 secondary outcomes, for example Secondary endpoints:.

What This Means in Plain Language

Put simply, this is a not phased, 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.