HumAn-1
This trial is funded by a grant from The Leona M. and Harry B. Helmsley Charitable Trust to the University of Pittsburgh
Background
Long-acting insulin analogues have become a de-facto standard of care for patients with Type 1 Diabetes (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 World Health Organization’s Model List of Essential Medicines 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). While it did eventually make the list in October 2021, experts remain divided on the decision and have called for more data about long-acting insulin’s effectiveness both in terms of cost and clinical impact. Moreover, studies conducted in high-income settings may not generalize to children and young adults living with T1D in very low-resource settings.
Sign up for the Newsletter
Objectives
The University of Pittsburgh with the (BWH) Brigham and Women’s Hospital, (LFAC) Life for a Child, (LSHTM) The London School of Hygiene & Tropical Medicine, and (CHAI) Clinton Health Access Initiative to conduct a randomized controlled trial comparing insulin glargine, a long-acting analogue insulin, against intermediate-acting human insulin among children and young adults living with T1D in a lower resource settings (Bangladesh and Tanzania).
Outcomes from that trial will include:
Time in serious hypoglycemia (blood glucose less than 54 mg/dl) and time in range (70-180 mg/dl), both measured by continuous glucose monitoring.
Exploratory studies (through partnerships with the LSHTM and CHAI) using quantitative and qualitative mixed methods to assess youth/caregiver satisfaction and the cost-effectiveness of more widespread use of analogue insulins in low-resourced settings.
People & Collaborators
PITT = University of Pittsburgh
TDA = Tanzania Diabetes Association
BIRDEM = Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
BADAS = Diabetic Association of Bangladesh
QoL Investigator = Quality of Life and Cost-Effectiveness Analysis
Endocrinologist = Pediatric Endocrinologist
Desired Outcomes
If the study demonstrates conclusively that long-acting analogue insulins are clinically superior to human insulins for children and young adults with T1D in low-resource settings, the University of Pittsburgh will work with its partners and other Helmsley supported grantees to continue international advocacy efforts, with the goal of reducing analogue insulin prices in around the world. The project would also continue to engage with the World Health Organization and biosimilar insulin manufacturers to push for prequalification of biosimilar insulin analogues, with the goal of decreasing the lowest available price for insulin analogues around the world.