Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Aspart.

This trial is conducted in Japan.

The registry classes the interventions as drug.

Who Took Part

The registry lists 289 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Subjects with type 2 diabetes. Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: proliferative retinopathy or maculopathy requiring acute treatment; impaired hepatic and/or renal function; cardiac diseases.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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.

It started in 2006-04 with completion listed for 2007-06.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Hemoglobin A1C (HbA1C) (time frame: After 16 weeks of treatment).

It also tracked 1 secondary outcome, for example HbA1C, after 28 weeks of treatment; Plasma glucose levels.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 289 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.