Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Insulin Aspart.

This trial is conducted in Europe.

The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.

It had two arms (groups): BIAsp 70 (experimental) and BIAsp 70 + BIAsp 50 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 16 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. Duration of diabetes for longer than 12 months. Body mass index (BMI) below 35.0 kg/m\^2.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: current treatment with agents affecting glucose metabolism; history of drug or alcohol dependence; impaired hepatic function.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 1999-03 with completion listed for 1999-06.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Fasting serum glucose.

It also tracked 4 secondary outcomes, for example 24-hour serum glucose profiles, 24-hour insulin profiles, Incidence of hypoglycaemic episodes and Incidence of adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 16 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.