Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756

What Was Tested

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

This trial is conducted in Asia.

It had two arms (groups): BIAsp 30 (2:1) (experimental) and BIAsp 30 (1:1) (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 179 actual participants took part.

It was open to people of any sex aged from 20 years up to 80 years.

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

Examples of who could join: Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in combination with metformin and glimepiride in trial BIAsp-3756. Body Mass Index (BMI) below or equal to 40.0 kg/m2.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial biasp-3756; known proliferative retinopathy or maculopathy requiring acute treatment; any disease or condition which the investigator (trial physician) feels would interfere with the trial.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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

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 2011-01 with completion listed for 2011-09.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline (time frame: Week 0, week 16).

It also tracked 4 secondary outcomes, for example 9-point SMPG (Self Measured Plasma Glucose) Profile and Number of Treatment Emergent Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 179 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.