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

NCT ID: NCT06717191

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2024-08-02

Brief Summary

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

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) 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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Introduction of Basaglar to insulin treatment regimen

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

Group Type: EXPERIMENTAL

biosimilar insulin glargine

Intervention Type: DRUG

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

Interventions

biosimilar insulin glargine

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

Intervention Type: DRUG

Other Intervention Names

Basaglar

Eligibility Criteria

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

• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baqai Institute of Diabetology and Endocrinology

OTHER

Sponsor Role: collaborator

Life for a Child Program, Diabetes Australia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Asher Fawwad

Role: PRINCIPAL_INVESTIGATOR

Baqai Insitute of Diabetology and Endocrinology (BIDE)

Locations

Baqai Institute of Diabetology and Endocrinology (BIDE)

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id