Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

This trial is conducted in Asia.

The registry classes the interventions as drug.

Who Took Part

The registry lists 219 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Type 1 or 2 diabetes for at least 3 months. Stabilised on current treatment with premixed human insulin for at least 4 weeks. Body mass index (BMI) between 18-40 kg/m2. Able and willing to perform self-blood glucose monitoring.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: the receipt of any investigational drug within the last three months prior to this trial; has a history of drug abuse or alcohol dependence within the last 5 years; active proliferative retinopathy requiring laser or surgical intervention within the last year.

How the Study Was Run

Design: 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.

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

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.

It started in 2003-07-08 with completion listed for 2003-11-26.

It ran at 6 sites in China (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 2-hr postprandial plasma glucose (PPPG) excursion (time frame: after 12 weeks of treatment).

It also tracked 2 secondary outcomes, for example HbA1c and Fasting plasma glucose.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 219 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.