Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs

What Was Tested

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

This trial is conducted in North America.

It had 1 arm (groups): BIAsp 30 (experimental).

The registry classes the interventions as drug.

Who Took Part

26 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: Type 2 diabetes mellitus for at least 12 months. An antidiabetic regimen that has been stable for at least 3 months prior to screening. An antidiabetic regimen that includes a minimum of 2 OADs.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: use of any insulin preparations within the past 6 months; active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-10 with completion listed for 2006-07.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Change in HbA1c, Total number of hypoglycemic events and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Aspart in 26 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.