Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Aspart.

It had two arms (groups): GP40071 (experimental) and NovoRapid® Penfill® (active comparator).

Subcutaneous (SC), before meals intake, up to Week 26.

Subcutaneous (SC), before meals intake, up to Week 26.

The registry classes the interventions as drug.

Who Took Part

264 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Signed written consent. Diabetes mellitus type 1 for at least 12 months prior to screening. Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive). Subject is able and willing to comply with the requirements of the study protocol.

The full record lists 6 inclusion and 29 exclusion criteria; among the exclusions: contraindication to the use of insulin aspart; change inn of insulin for 6 months prior to randomisation; history of treatment any experimental drugs or medical devices for 3 months prior to randomisation.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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

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 2019-06-03 with completion listed for 2020-01-21.

It ran at 14 sites in Russia (14).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Immunogenicity (time frame: 26 weeks).

It also tracked 9 secondary outcomes, for example Glycated hemoglobin, Adverse Events frequency and degree, Fasting Plasma Glucose Level, Seven-Point Glucose Testing, Body Mass Index and Treatment Satisfaction.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 264 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.