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

Jing Luo

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1; Type 1 Diabetes

Treatments: Drug: Insulin Glargine; Drug: NPH or premixed 70/30 (human insulin)

Study type: Interventional

Funder types: Other

Identifiers

NCT05614089

STUDY21110122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 7 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Glargine

Experimental group

Description:

Insulin glargine (long-acting insulin analogue)

Treatment:

Drug: Insulin Glargine

NPH or premixed 70/30 (human insulin)

Active Comparator group

Description:

NPH or premixed 70/30 (human insulin)

Treatment:

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