Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Aspart.

This trial is conducted in Asia.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 193 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 for at least 24 months. BMI between 18 and 30 kg/m2. Insulin naive subjects. OAD treatment with max two OADs alone or combined with other therapy.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: type 1 diabetes; receipt of any investigational drug within the last three months prior to this trial; current or previous treatment with thiazolidiones within the last 6 months.

How the Study Was Run

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

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

The Insulin Aspart group and the comparison group ran side by side rather than switching.

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

It started in 2003-12 with completion listed for 2004-10.

It ran at 17 sites in Australia (5), Malaysia (3), Hong Kong (2), Philippines (2), Taiwan (2) and Thailand (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: after 11 weeks of treatment).

It also tracked 3 secondary outcomes, for example 8-point plasma glucose profiles and FPG.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 193 people.

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.