Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes

What Was Tested

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

This trial is conducted in Japan.

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

The registry classes the interventions as drug.

Who Took Part

83 actual participants took part.

It was open to people of any sex aged from 20 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. Subjects with insulin treated for at least 24 weeks. Body mass index (BMI) below 30.0 kg/m\^2. Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: recurrent severe hypoglycaemia; subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year; impaired hepatic function.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2000-12-13 with completion listed for 2001-10-18.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycosylated haemoglobin A1c (HbA1c).

It also tracked 5 secondary outcomes, for example Occurrence of adverse event(s), Blood glucose, Incidence of hypoglycaemic episodes and Change from baseline in insulin antibodies.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 83 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.