Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes

What Was Tested

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

This trial is conducted in Europe.

The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

It had two arms (groups): BIAsp 50 or 70 (experimental) and BHI 30 (active comparator).

The registry classes the interventions as drug.

Who Took Part

666 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 1 or Type 2 diabetes. Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents. Body mass index (BMI) maximum 40.0 kg/m\^2.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: history of drug or alcohol dependence; impaired hepatic function; impaired renal function.

How the Study Was Run

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

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.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2000-03 with completion listed for 2001-04.

It ran at 77 sites in United Kingdom (29), France (27), Netherlands (11), Belgium (7) and Ireland (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (glycosylated haemoglobin A1c).

It also tracked 5 secondary outcomes, for example Blood glucose profiles, Adverse events, Hypoglycaemic episodes, Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ) and Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 666 people.

With 666 participants it is a large trial for this field.

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.