Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Insulin Aspart.

This trial is conducted in Europe.

The registry classes the interventions as drug.

Who Took Part

71 actual participants took part.

It was open to people of any sex aged from 35 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. Insulin naive diabetes. Current treatment with OHA, secondary failure. Body mass index (BMI) below 40 kg/m2. Willing and able to start with insulin therapy and to perform self-blood glucose monitoring.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: history of drug or alcohol abuse; receipt of the investigational drug within the last month prior to this trial; known or suspected allergy to trial products or related products.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-03 with completion listed for 2005-01.

It ran at 4 sites in Serbia and Montenegro (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: after 12 weeks of treatment).

It also tracked 3 secondary outcomes, for example Blood glucose profiles, Incidence of hypoglycaemic episodes and Incidence of adverse events.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Aspart in 71 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.