Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs

What Was Tested

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

This trial is conducted in Europe.

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

The registry classes the interventions as drug.

Who Took Part

161 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 more than 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 oral anti-diabetic drugs (OADs) or 1 OAD plus evening or bedtime basal insulin.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: use of any insulin preparations other than nph or glargine within the past 6 months; morning time insulin administration.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

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

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

It started in 2007-10 with completion listed for 2009-01.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Number of Hypoglycaemic Episodes, Number of Diurnal Hypoglycaemic Episodes, Number of Nocturnal Hypoglycaemic Episodes and Number of Treatment Emergent Serious Adverse Events (SAEs).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Aspart in 161 people.

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.