Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects

What Was Tested

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

This trial is conducted in Europe.

It had four arms (groups): BIAsp 30 (experimental), BIAsp 50 (experimental), BIAsp 70 (experimental) and Insulin aspart (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 35 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Body mass index between 18 and 28 kg/m\^2 inclusive. HbA1c within the normal laboratory range. Non smoker for at least three months. Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: any disease requiring regular use of non topical prescription medicines; any intercurrent illness or endocrine disorders that may affect blood glucose; subject with a history of drug or alcohol dependence.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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 1999-04 with completion listed for 2000-05.

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 GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes.

It also tracked 7 secondary outcomes, for example Maximum GIR value, Time to maximum GIR value, Area under the GIR profile, Cmax, maximum insulin aspart concentration, Area under the insulin aspart concentration curve and tmax, the time to maximum insulin aspart concentration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 35 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.