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

NCT06674135 | Completed Phase 4 FDA Drug

• 1 other identifier: BADAS-ERC/EC/22/00325
• Study Type: interventional
• Target: 202
• 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 Bangladesh

Conditions

Type I Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  HbA1c was measured at each study time point using the Minicap Sebia Autoanalyzer with venous blood

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

Secondary Outcomes (4)

• Proportion of participants experiencing episodes of diabetic ketoacidosis

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

• Proportion of participants experiencing episodes of severe hypoglycaemia

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

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

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

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

You may qualify if:

• Diagnosed with type 1 diabetes (T1D). Diabetes was diagnosed in accordance with World Health Organization (WHO) criteria. Determination of diabetes type was made by the local investigators according to available clinical features and history: T1D was diagnosed upon abrupt onset of typical symptoms of diabetes with insulin required from diagnosis, and no acanthosis nigricans. They were usually non-obese.
• Duration of T1D at enrolment \>12 months
• Aged 10-25 years (inclusive) at time of enrolment
• Current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin
• Attending Life for a Child, BIRDEM Hospital, Dhaka for their usual diabetes care

You may not qualify if:

• Previous use of analog insulin

Sponsors & Collaborators

• Life for a Child Program, Diabetes Australia: lead
• Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders: collaborator
• BADAS-Centre for Health Research and Implementation: collaborator
• Diabetic Association of Bangladesh (BADAS): collaborator

Study Sites (1)

BIRDEM, the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

Dhaka, Bangladesh

Location

Related Publications (1)

• Skinner TC, Hoey H, McGee HM, Skovlund SE; Hvidore Study Group on Childhood Diabetes. A short form of the Diabetes Quality of Life for Youth questionnaire: exploratory and confirmatory analysis in a sample of 2,077 young people with type 1 diabetes mellitus. Diabetologia. 2006 Apr;49(4):621-8. doi: 10.1007/s00125-005-0124-0. Epub 2006 Jan 26.

  PMID: 16525844 BACKGROUND

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

• Dr Bedowra Zabeen, MBBS, FCPS(Paediatrics), FRSPH

  Life For a Child Program, BIRDEM, BADAS, Bangladesh

  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: November 3, 2024
• First Posted: November 5, 2024
• Study Start: June 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)