Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

It had 1 arm (groups): Introduction of Basaglar to insulin treatment regimen (experimental).

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 2022, LFAC commenced supplying Basaglar (glargine) insulin with insulin pen devices (HumaPen Ergo ll).

Who Took Part

202 actual participants took part.

It was open to people of any sex aged from 10 years up to 25 years.

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

Examples of who could join: Duration of T1D at enrolment \>12 months. Aged 10-25 years (inclusive) at time of enrolment. Current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin.

The full record lists 5 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-06-01 with completion listed for 2023-08-31.

It ran at 1 site in Bangladesh.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean and median HbA1c (% and mmol/mol) (time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits).

It also tracked 4 secondary outcomes, for example Proportion of participants experiencing episodes of severe hypoglycaemia and Participant self-reported satisfaction.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine in 202 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.