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

NCT05614089 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY21110122
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 3

Brief 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

Diabetes Mellitus, Type 1; Type 1 Diabetes

Keywords

Type 1 Diabetes; Insulin Glargine; Human Insulin; Insulin Analogue; Bangladesh; Tanzania

Outcome Measures

Primary Outcomes (2)

• Time-in-serious Hypoglycemia

  % time spent less than 54 mg/dl averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months.

  6 and 12 months after randomization

• Time-in-range (TIR)

  % time spent between 70 and 180mg/dl inclusive averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months.

  6 and 12 months after randomization

Secondary Outcomes (9)

• Time-in-hypoglycemia

  6 and 12 months after randomization

• Time-above-range

  6 and 12 months after randomization

• Nocturnal Hypoglycemic Events

  6 and 12 months after randomization

• Glycemic Control (HbA1c)

  baseline, 3, 6, 9 and 12 months after randomization

• Rate of Severe Hypoglycemic Events

  6 and 12 months after randomization

Study Arms (2)

Glargine

EXPERIMENTAL

Insulin glargine (long-acting insulin analogue)

Drug: Insulin Glargine

NPH or premixed 70/30 (human insulin)

ACTIVE COMPARATOR

NPH or premixed 70/30 (human insulin)

Drug: NPH or premixed 70/30 (human insulin)

Interventions

Insulin Glargine DRUG

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

Glargine

NPH or premixed 70/30 (human insulin) DRUG

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

NPH or premixed 70/30 (human insulin)

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and young adults (age 7-25)
• Have a clinical diagnosis of type 1 diabetes (T1D)

You may not qualify if:

• Prior use of any insulin analogue
• Patients (or parents for children \<18 years old) who refuse to or cannot provide informed consent
• Who are currently pregnant or plan to become pregnant over the next year
• Who have previously used a continuous glucose monitor (CGM) for glucose monitoring
• Who were first diagnosed with T1D less than 12 months ago
• Who is diagnosed with severe malnutrition

Sponsors & Collaborators

• Jing Luo: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (3)

BIRDEM Hospital

Dhaka, Bangladesh

Location

Bugando Medical Center

Mwanza, Tanzania

Location

Sekou-Toure Hospital

Mwanza, Tanzania

Location

Related Publications (1)

• Foulds A, Josey C, Kehlenbrink S, Rollman BL, Chang CH, Lalama C, Ansbro E, Prust ML, Zabeen B, Ramaiya K, Ogle G, Chae SR, Luo J. Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial. BMJ Open. 2025 Jan 30;15(1):e092432. doi: 10.1136/bmjopen-2024-092432.

  PMID: 39890140 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Insulin Glargine; Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Jing Luo, MD, MPH, Associate Professor of Medicine
• Organization: University of Pittsburgh

luoj@pitt.edu

412-383-3559

Study Officials

• Jing Luo, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 14, 2022
• Study Start: March 15, 2023
• Primary Completion: August 13, 2024
• Study Completion: March 19, 2025
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 3 years after the completion of the primary endpoint (Start 16 September 2024; End 16 September 2027)
• Access Criteria: Researchers who provide a methodologically sound proposal, upon request

Locations

BA (1); TA (2)