Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control 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 Asia.

It had two arms (groups): BIAsp 50-50-30 (experimental) and BIAsp 30-30 (active comparator).

Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin.

Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 441 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. Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months. BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive).

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: metformin contraindications according to local practice; systemic use of tzds (thiazolidinediones) for more than 1 month within 6 months prior to this trial.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

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 2008-02 with completion listed for 2009-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Glycosylated Haemoglobin A1c (HbA1c) (time frame: week 0, week 16).

It also tracked 7 secondary outcomes, for example The Percentage of Subjects Achieving HbA1c Treatment Targets, Change and Daily Average in 8-point Plasma Glucose, Change and Daily Average in Prandial Plasma Glucose Increment, Change in Body Weight, Number of Hypoglycaemic Episodes and Number of Nocturnal Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 441 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.