Impact of Introducing Basaglar Insulin to the Treatment Regimen of Youth With Diabetes in Pakistan

What Was Tested

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

This provided a unique opportunity to investigate the effect of introducing glargine (Basaglar) insulin in the low resource setting of Pakistan.

Who Took Part

Enrollment: 296 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.

Examples of who could join: Duration of T1D ≥ 12 months at time of enrolment. Willing to conduct self-monitoring of blood glucose (SMBG) at least twice daily. No prior use of analog insulin (either long-acting or short-acting). Willing to adhere to the study protocol, including attending follow-up visits and participating in the required education sessions.

The full record lists 7 inclusion and 2 exclusion criteria; among the exclusions: prior use of analog insulin; other medical conditions that would interfere with study participation.

How the Study Was Run

Design: single-group and open-label.

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

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

It started in 2022-06-09 with completion listed for 2024-06-15.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean and median HbA1c (% and mmol/mol) (time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits). Proportion of participants experiencing episodes of severe hypoglycaemia (time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits). Proportion of participants experiencing episodes of diabetic ketoacidosis (time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine in 296 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.