Efficacy and Safety of Biphasic Insulin Aspart 30 With Metformin in Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Aspart.

This trial is conducted in Africa.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 140 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 2 diabetes. Body mass index (BMI) below 40.0 kg/m2.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: history of drug or alcohol dependence; mental incapacity, unwillingness or language barriers precluding adequate; subjects previously screened to participation or having already participated in this trial.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

The Insulin Aspart group and the comparison group ran side by side rather than switching.

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

It started in 2004-05 with completion listed for 2005-05.

It ran at 15 sites in South Africa (15).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: after 24 weeks of treatment).

It also tracked 4 secondary outcomes, for example Plasma glucose profiles, Cardiovascular risk factors, Incidence of hypoglycaemic episodes and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 140 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.