Clinical trial NCT05614089: Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings
Official title: Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Type 1 Diabetes
Keywords: Type 1 Diabetes
Insulin Glargine
Human Insulin
Insulin Analogue
Bangladesh
Tanzania
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2022-11-14
Enrollment: 400
Sex: ALL
Minimum age (years): 7
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time-in-serious hypoglycemia
timeFrame: 6 months after randomization
measure: Time-in-range (TIR)
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Time-in-hypoglycemia
timeFrame: 6 months after randomization
measure: Time-above-range
timeFrame: 6 months after randomization
measure: Nocturnal hypoglycemic events
timeFrame: 6 months after randomization
measure: Glycemic control (HbA1c)
timeFrame: baseline, 3, 6, 9 and 12 months after randomization
measure: Rate of severe hypoglycemic events
timeFrame: 6 months after randomization
measure: Rate of Diabetic Ketoacidosis
timeFrame: 6 months after randomization
measure: Quality of Life (e.g. PedsQL Pediatric Quality of Life Inventory)
timeFrame: Baseline and at 6 and 12 months after randomization
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: BIRDEM Hospital
city: Mwanza
country: Tanzania
facility: Bugando Medical Center
city: Mwanza
country: Tanzania
facility: Sekou-Toure Hospital
Study officials:
affiliation: University of Pittsburgh
name: Jing Luo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: