Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human).

This trial is conducted in Asia and Oceania.

The registry classes the interventions as drug.

Who Took Part

241 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: Duration of diabetes for at least 12 months. Basal/bolus treatment with human insulin for at least 2 months preceding trial start. Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months; known or suspected allergy against trial product or related products.

How the Study Was Run

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

Because people in this Insulin (regular human) 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 (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2003-05-01 with completion listed for 2004-01-19.

It ran at 15 sites in Australia (7), Philippines (4), Malaysia (3) and Hong Kong (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change of human insulin antibodies (time frame: after 26 weeks of treatment).

It also tracked 2 secondary outcomes, for example Change of human insulin antibodies and Frequency of adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 241 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.