Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Aspart.

This trial is conducted in Europe.

The aim of this trial is to investigate the difference in frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30 compared to biphasic human insulin 30 in subjects with well controlled 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 170 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. Treated with insulin 1-3 injections daily for at least 6 months. Body Mass Index (BMI) below 40 kg/m\^2.

The full record lists 4 inclusion and 2 exclusion criteria.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2002-06 with completion listed for 2003-11.

It ran at 17 sites in United Kingdom (17).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Frequency of hypoglycaemic episodes.

It also tracked 4 secondary outcomes, for example Frequency of reported severe hypoglycaemic episodes, Overall frequency of nocturnal hypoglycaemia, HbA1c (glycosylated haemoglobin A1c) and Diabetes Treatment Satisfaction Questionaire.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 170 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.