Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone

What Was Tested

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

This trial is conducted in Asia.

It had two arms (groups): Pre-breakfast BIAsp 30 (experimental) and Pre-dinner BIAsp 30 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 245 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: Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1. Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed). An antidiabetic regimen that has been stable for at least 3 months prior to screening. An antidiabetic regimen that includes a minimum of 2 OADs.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; the receipt of any investigational medicinal product within one month prior to this trial; suffer from a life threatening disease (cancer).

How the Study Was Run

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

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 2011-03 with completion listed for 2012-09.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11 (time frame: Week 0, Week 11).

It also tracked 2 secondary outcomes, for example Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36 and Number of Treatment Emergent Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 245 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page, all human trials.