Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Aspart.

The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch.

It had three arms (groups): Biphasic Insulin Aspart 30 (active comparator), Biphasic Insulin Aspart 70 (active comparator) and Insulin Aspart (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 35 years up to 75 years.

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

Examples of who could join: BMI \> 27 kg/m2. Age 35 to 75 years. Treatment with pre-mixed insulin.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: type-i diabetes mellitus; alaninaminotranferase or aspartataminotransferase \> 3x upper limit of normal; treatment with sulfonylurea or gliptins.

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.

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

It started in 2010-06 with completion listed for 2011-02.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area Over Basal for Postprandial Glucose From 0 to 600min. Area Over Basal for Postprandial Triglycerides.

It also tracked 4 secondary outcomes, for example Area Over Basal for Postprandial Insulin and Area Over Basal for Postprandial C-peptide.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page, all human trials.