Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

What Was Tested

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

This trial is conducted in Asia.

The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin.

Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.

It had two arms (groups): Subject-driven titration (experimental) and Investigator-driven titration (active comparator).

The registry classes the interventions as drug.

Who Took Part

344 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months. Body Mass Index (BMI) below or equal to 35.0 kg/m\^2.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (csii)) for more than 14 days; known proliferative retinopathy or maculopathy requiring treatment.

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.

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

It started in 2012-06 with completion listed for 2013-01.

It ran at 22 sites in China (22).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 20).

It also tracked 4 secondary outcomes, for example Change From Baseline in FPG (Fasting Plasma Glucose) and Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 344 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.