NCT06624943

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Life for a Child Program, Diabetes Australia · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate the impact on blood glucose control and quality of life in children and youth with type 1 diabetes in Mali by switching the insulin regimen from human insulin via needle and syringe, to long-acting biosimilar insulin glargine delivered by reusable pens combined with short-acting insulin via needle and syringe.

Detailed description

Analog insulins are widely used in middle- and high-income countries. However, use of analog insulin remains limited in lower-income countries due to their increased cost and lack of access, and human insulin remains the mainstay of treatment in these settings. Long-acting (basal) analog insulin such as glargine have the benefit of a longer duration (up to 24 hours) and a minimal peak action, and generally, only one injection per day is required. Although glargine insulin has been shown to reduce the risk of overnight hypoglycemia, consistent improvement in blood glucose control (measured by HbA1c) when compared to human insulin has not been shown, and its impact on quality of life is also inconclusive. Furthermore, these studies have all been done in highly resourced countries. Life for a Child (LFAC) has been providing diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to Santé Diabète in Mali since 2008. 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.

Conditions

• Type 1 Diabetes (T1D)

Interventions

Type	Name	Description
DRUG	biosimilar insulin glargine	Once daily injection of biosimilar insulin glargine via reusable pen

Timeline

• Start date: 2022-03-14
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2024-10-03
• Last updated: 2024-10-03

Locations

1 site across 1 country: Mali

Regulatory

• FDA-regulated drug study