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

NCT ID: NCT05614089

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2025-03-19

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.

Detailed Description

Long-acting insulin analogues have become a de-facto standard of care for patients with T1D living in high-income countries. Unfortunately, insulin analogues remain unavailable or unaffordable for much of the global population. In both 2017 and 2019, applications to add long-acting insulin analogues to the WHO's Model List of Essential Medicines (EML) were rejected due to insufficient evidence of superiority and an unfavorable cost-effectiveness profile when compared against older, less expensive, human insulins (e.g., NPH insulin and premixed 70/30 insulin). In 2021, long-acting insulin analogues were added to the EML but the decision remains controversial since the WHO concluded that "magnitude of clinical benefit of long-acting insulin analogues over human insulin for most clinical outcomes was small." Moreover, studies that compare long-acting insulin analogues versus human insulins conducted in high-income settings may not generalize to children and young adults living with T1D in very low-resource settings.

To address this unmet need, Pitt has partnered with Brigham and Women's Hospital, The London School of Hygiene and Tropical Medicine, the Clinton Health Access Initiative and Life For a Child to conduct a randomized controlled trial comparing insulin glargine, a long-acting analogue insulin, against intermediate human insulin among 400 children and young adults living with T1D in a lower resource setting.

Note: In preparation for results submission, we made minor changes to the outcomes sections to reflect what is listed in the protocol.

For Primary Outcomes #1 and #2, and Secondary Outcomes #3,#4, #5, #7, #8: we added 12 months measurements (in addition to the 6 months measurement). We updated Secondary Outcome #9 to specify the PedsQL Diabetes Symptoms Score. We added Secondary Outcome #10 to include the PedsQL Diabetes Management Score. We added Secondary Outcome #11 for ITSQ scores.

Conditions

Diabetes Mellitus, Type 1; Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glargine

Insulin glargine (long-acting insulin analogue)

Group Type: EXPERIMENTAL

Insulin Glargine

Intervention Type: 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

NPH or premixed 70/30 (human insulin)

NPH or premixed 70/30 (human insulin)

Group Type: ACTIVE_COMPARATOR

NPH or premixed 70/30 (human insulin)

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Children and young adults (age 7-25)

2. Have a clinical diagnosis of type 1 diabetes (T1D)

Exclusion Criteria

1. Prior use of any insulin analogue

2. Patients (or parents for children <18 years old) who refuse to or cannot provide informed consent

3. Who are currently pregnant or plan to become pregnant over the next year

4. Who have previously used a continuous glucose monitor (CGM) for glucose monitoring

5. Who were first diagnosed with T1D less than 12 months ago

6. Who is diagnosed with severe malnutrition

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Jing Luo

OTHER

Sponsor Role: lead

Responsible Party

Jing Luo

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jing Luo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

BIRDEM Hospital

Dhaka, , Bangladesh

Bugando Medical Center

Mwanza, , Tanzania

Sekou-Toure Hospital

Mwanza, , Tanzania

Countries

Bangladesh; Tanzania

References

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.

Reference Type: DERIVED

PMID: 39890140 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Informed Consent_ Bangladesh site

View Document

Document Type: Informed Consent Form: Informed Consent_ Tanzania site

View Document

Other Identifiers

STUDY21110122

Identifier Type: -

Identifier Source: org_study_id