Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Aspart.

This this trial is conducted in Europe.

The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.

It had two arms (groups): BIAsp (experimental) and Insulin aspart (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 131 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. Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months. Willing and able to perform self blood glucose monitoring (SMBG).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: history of drug or alcohol dependence; mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation; previous participation in this trial.

How the Study Was Run

Design: 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.

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 2002-07-22 with completion listed for 2003-04-24.

It ran at 12 sites in Poland (12).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (glycosylated haemoglobin).

It also tracked 4 secondary outcomes, for example 7-point blood glucose profile, Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification, Incidence of adverse events and Hypoglycaemic episodes (minor, major or nocturnal).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 131 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.