Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Insulin Aspart.

This trial is conducted in Europe.

The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.

It had two arms (groups): Treatment period 1 (experimental) and Treatment period 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 31 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: Subjects with Type 2 diabetes. Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months. BMI (Body Mass Index) maximum 35.0 kg/m2. Able and willing to perform self-blood glucose monitoring (SBGM).

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: the receipt of any investigational drug within the last 30 days prior to this trial; A history of drug abuse or alcohol dependence within the last 5 years; impaired hepatic function.

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

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 2002-05 with completion listed for 2002-11.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glucose average in 24-hour blood glucose profiles.

It also tracked 6 secondary outcomes, for example Pre-meal glucose level, Post-meal excursion of glucose (0-4 hours), Cmax, maximum concentration of total insulin, tmax, time of maximum concentration of total insulin, The area under the 24-hour total insulin concentration time curve and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Aspart in 31 people.

Its size is small, so on its own it can only give an early look.

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.