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

Life for a Child Program, Diabetes Australia

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes

Treatments: Drug: biosimilar insulin glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT06717191

PROF.DR.FAWWAD/006/08/22/0157

Details and patient eligibility

About

This study aimed to determine the effect of introducing Basaglar and insulin pen injection devices on clinical and quality of life (QOL) parameters in children and young adults with type 1 diabetes in Pakistan

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) provides diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to the team managing youth with type 1 diabetes (T1D) managed at Baqai Institute of Diabetology and Endocrinology (BIDE) in Karachi, Pakistan. 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.

Enrollment: 296 patients

Sex: All

Ages: 10 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with type 1 diabetes according to a combination of clinical (polyuria, polydipsia, and weight loss) and biochemical characteristics (High blood glucose levels (fasting glucose ≥ 126 mg/dL or random glucose ≥ 200 mg/dL) and/or C-peptide levels indicating low insulin production, along with the presence of islet autoantibodies (e.g., GAD65, IA-2))
• 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)
• Attending BIDE for their routine diabetes care and management
• No history of other significant medical conditions (e.g., severe renal disease or other autoimmune conditions)
• Willing to adhere to the study protocol, including attending follow-up visits and participating in the required education sessions

Exclusion criteria

• Prior use of analog insulin
• Other medical conditions that would interfere with study participation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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296 participants in 1 patient group

Introduction of Basaglar to insulin treatment regimen

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