Introducing Biosimilar Insulin Glargine to the Treatment Regimen of Children and Youth with Type 1 Diabetes in Mali

What Was Tested

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

It had two arms (groups): Control (no intervention) and Intervention (experimental).

Continue current treatment with either intermediate- and short-acting human insulin, or pre-mixed insulin, both via needle and syringe.

Switched to once daily injection of biosimilar insulin glargine via reusable pen and three mealtime bolus insulin injections of short-acting human insulin via needle and syringe.

The registry classes the interventions as drug.

More on the Plan

Analog insulins are widely used in middle- and high-income countries.

Furthermore, these studies have all been done in highly resourced countries.

In 2021, LFAC commenced supplying Basaglar (glargine) insulin with insulin pen devices (HumaPen Ergo ll).

This provided a unique opportunity to investigate the effect of introducing glargine (Basaglar) insulin in the low-resource setting of Mali, one of the world's poorest countries.

Who Took Part

The registry lists 260 actual participants took part.

It was open to people of any sex aged up to 25 years.

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

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2022-03-14 with completion listed for 2023-05-05.

It ran at 1 site in Mali.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits).

It also tracked 5 secondary outcomes, for example Episodes of diabetic ketoacidosis, Episodes of severe hypoglycaemia, Participant self-reported satisfaction (intervention arm only) and Feedback from local HCPs on implementation of the study intervention.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 260 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, all human trials.