Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)

What Was Tested

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

This study evaluates in a group of people with DM 1 the influence in parameters of oxidative stress of the treatments with the different current analogs of insulin.

It had six arms (groups): Tresiba & NovoRapid (other), Toujeo SoloStar & NovoRapid (other), Tresiba & Humalog Kwikpen (other), Toujeo SoloStar & Humalog Kwikpen (other) and Tresiba & Apidra (other).

Patients treated with Tresiba insulin and NovoRapid insulin.

Patients treated with Toujeo SoloStar insulin and NovoRapid insulin.

Patients treated with Tresiba insulin and Humalog kwikpen insulin.

The registry classes the interventions as drug.

Who Took Part

300 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: Age between 18 years and 65 years (inclusive). DM1 of more than two years of evolution with habitual follow-up in the Diabetes Unit of the University Regional Hospital of Malaga. Intensive treatment with basal MDI - Bowl for more than 12 months prior to the start of study. Gives informed consent.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled); pregnancy or pregnancy planning; diabetes mellitus type 2.

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 Glargine and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2017-01-20 with completion listed for 2020-11-30.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Oxidative stress markers with the new slow insulin analogues (time frame: 6 month).

It also tracked 13 secondary outcomes, for example HbA1c, Mean blood glucose, Standard deviation, Number of mild hypoglycemia, Number of severe hypoglycemia and Number of hyperglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 300 people.

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

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