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

NCT06624943 | Completed Phase 4 FDA Drug

• 2 other identifiers: 2022/27/CE/USTTB#2208-05490
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes (T1D)

Keywords

children; adolescents; insulin glargine; Mali

Outcome Measures

Primary Outcomes (1)

• HbA1c

  HbA1c was measured at each study time point using point of care testing via a Siemens DCA calibrated to international standards (DCA Vantage™ Analyzer (Siemens Healthcare Diagnostics, Tarrytown NY, US)). For HbA1c readings \>14% (\>130 mmol/mol), the maximum reading of this analyser, HbA1c was recorded as 14% (130 mmol/mol).

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

Secondary Outcomes (5)

• Episodes of diabetic ketoacidosis

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

• Episodes of severe hypoglycaemia

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

• Diabetes Quality of Life in Youth - Short Form

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

• Participant self-reported satisfaction (intervention arm only)

  12-month follow-up visit

• Feedback from local HCPs on implementation of the study intervention

  At 12 months

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

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

Once daily injection of biosimilar insulin glargine via reusable pen

Also known as: Basaglar

Intervention

Eligibility Criteria

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

You may qualify if:

• (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

You may not qualify if:

• (i) Previous use of analog insulin

Sponsors & Collaborators

• Life for a Child Program, Diabetes Australia: lead
• Sante Diabete Mali: collaborator
• Hospital of Mali: collaborator
• Centre Hospitalier du Luxembourg: collaborator
• University Hospital, Geneva: collaborator

Study Sites (1)

Hôpital du Mali

Bamako, Mali

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

• Stéphane Besançon, MSC

  ONG Santé Diabète,Bamako,Mali & Unité PACRI,Conservatoire National des Arts et Métiers,Paris,France

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 3, 2024
• Study Start: March 14, 2022
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)