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Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings

NCT05614089 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-09-10

Study results available
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Summary

The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.

Conditions

Interventions

DRUG

Insulin Glargine

Formulation: Available as a clear liquid in a glass cartridge (1 cartridge =3ml=300 units). Route: Reusable pen Amount of each dose: varies depending on baseline basal insulin needs Dose escalation scheme: Participants randomly assigned to glargine will start with a dose that is generally equal to 80% of their total basal human insulin dose prior to the switch (per ISPAD guidelines and the switching guide developed by Life for a Child with the guidance of Dr. Ragnar Hanas and two other ISPAD members familiar with less-resourced settings). Frequency of dose: once per day (usually administered before bedtime) Duration of therapy: 12 months

DRUG

NPH or premixed 70/30 (human insulin)

Formulation: Available as a liquid in a glass cartridge (3ml=300IU) or as liquid in a prefilled, disposable pen (3ml=300IU). Route: Bangladesh = reusable pens; Tanzania = disposable pens Amount of each dose: varies depending on baseline basal insulin needs (per usual care or treating clinician) Frequency of dose: once or twice per day (per usual care or treating clinician) Duration of therapy: 12 months

Sponsors & Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • Jing Luo

    lead OTHER

Principal Investigators

  • Jing Luo, MD, MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2024-08-13
Completion
2025-03-19
FDA Drug
Yes

Countries

  • Bangladesh
  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05614089 on ClinicalTrials.gov