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

NCT06717191 | Completed Phase 4 FDA Drug

• 1 other identifier: PROF.DR.FAWWAD/006/08/22/0157
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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

Conditions

Type 1 Diabetes

Keywords

Analog insulin; Basaglar; Pakistan; Children and Adolescents; Type 1 diabetes; insulin pen-devices

Outcome Measures

Primary Outcomes (3)

• Mean and median HbA1c (% and mmol/mol)

  HbA1c was measured at each study time point using High Performance Liquid Chromatography (HPLC (BIO-RAD, D10))

  Baseline, 3-, 6-, 9- and 12-month follow-up visits

• Proportion of participants experiencing episodes of severe hypoglycaemia

  Severe hypoglycaemia was defined as an event with severe cognitive impairment (with or without coma and convulsions) requiring assistance by another person to administer carbohydrates, glucagon, or intravenous dextrose to restore glycaemia

  Baseline, 3-, 6-, 9- and 12-month follow-up visits

• Proportion of participants experiencing episodes of diabetic ketoacidosis

  Diabetic ketoacidosis was defined as hyperglycaemia (BGL\>11mmol/L/200mg/dL) with a venous pH\<7·3 or serum bicarbonate \<15mmol/L and ketonaemia and ketonuria

  Baseline, 3-, 6-, 9- and 12-month follow-up visits

Secondary Outcomes (1)

• Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)

  Baseline, 6- and 12-month follow-up visits

Other Outcomes (1)

• Participant self-reported satisfaction

  12-month follow-up visit

Study Arms (1)

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

Drug: biosimilar insulin glargine

Interventions

biosimilar insulin glargine 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

Also known as: Basaglar

Introduction of Basaglar to insulin treatment regimen

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Life for a Child Program, Diabetes Australia: lead
• Baqai Institute of Diabetology and Endocrinology: collaborator

Study Sites (1)

Baqai Institute of Diabetology and Endocrinology (BIDE)

Karachi, Sindh, 74600, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Prof. Asher Fawwad

  Baqai Insitute of Diabetology and Endocrinology (BIDE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 4, 2024
• Study Start: June 9, 2022
• Primary Completion: June 15, 2024
• Study Completion: August 2, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)