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

Life for a Child Program, Diabetes Australia

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes (T1D)

Treatments: Drug: biosimilar insulin glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT06624943

2022/27/CE/USTTB

#2208-05490 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: All

Ages: Under 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

(i) diagnosed with T1D in accordance with World Health Organization criteria

(ii) duration of T1D ≥12 months at time of enrolment

(iii) aged <25 years at time of enrolment

(iv) current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin

(vi) willing to regularly self-monitor blood glucose (SMBG) levels ≥2 times a day with a blood glucose meter and strips

(vii) live in or within one hour's travelling distance of Bamako

Exclusion criteria

(i) Previous use of analog insulin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Control

No Intervention group

Description:

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

Intervention

Experimental group

Description:

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

Treatment:

Drug: biosimilar insulin glargine