HumAn-1

This trial is funded by a grant from The Leona M. and Harry B. Helmsley Charitable Trust to the University of Pittsburgh

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.

African Kid
The study runs from 12/1/2021 to 11/30/2024.
Iraqian Kid

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.

Tanzania
Bangladesh
Tanzania

People & Collaborators

PITT
Jing Luo
Principal Investigator
PITT
Andrew Althouse
Study Statistician
PITT
Abigail Foulds
Program Manager
PITT
Bruce Rollman
Clinical Trials Expert
PITT
Trevor Orchard
Consultant
PITT
Laurien Sibomana
Research Analyst
BWH
Sylvia Kehlenbrink
Co-Investigator
BWH
Sanjana Kattera
Fellow
LFAC
Graham Ogle
Consultant
LSHTM
Eimhin Ansbro
Qualitative Lead
LSHTM
Pablo Perel
Global Clinical Trials Consultant
CHAI
Margaret Prust
QoL Investigator
CHAI
Alana Garvin
QoL Investigator
BIRDEM
Bedowra Zabeen
Local Site Principal Investigator
BIRDEM
Kamrul Huda
Program Manager
BIRDEM
Shakil Khan
Project Administrator, BADAS
TDA
Kaushik Ramaiya
Local Site Principal Investigator
TDA
Edna Majaliwa
Endocrinologist
TDA
Renatus Fabiano
Program Manager
PITT
Jing Luo
Principal Investigator
PITT
Andrew Althouse
Study Statistician
PITT
Abigail Foulds
Program Manager
PITT
Bruce Rollman
Clinical Trials Expert
PITT
Trevor Orchard
Consultant
PITT
Laurien Sibomana
Research Analyst
View More
  • 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.

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