$32M Project Launches to Investigate Hypoglycemia, Build Better Data

A new research project aimed at finding better solutions to hypoglycemia launched this week in Denmark, involving 23 international groups that include the JDRF, and diabetes therapy manufacturer Novo Nordisk.

Called Hypo-RESOLVE, the project is supported by $32 million from the Innovative Medicines Initiative, a joint effort of the European Commission and the European Federation of Pharmaceutical Industries and Associations, along with JDRF, and the Leona M. and Harry B. Helmsley Charitable Trust. Stephen Gough, MD, global chief medical officer at Novo Nordisk in Denmark and Hypo-RESOLVE project leader, said in a statement, “This consortium brings together world leaders from the field of diabetes to reduce the burden of hypoglycemia. Hypo-RESOLVE paves the way for further research on glucose-lowering interventions that will serve people living with diabetes, clinicians and healthcare companies.”

Hypoglycemia, a common condition in diabetes, involves very low levels of blood glucose; when it occurs frequently, it can lead to cognitive decline, cardiovascular events and even death. Patients with type 1 diabetes are especially at risk for hypoglycemia. In recent years, both the clinical and advocacy communities have called upon regulators in the United States as well as in Europe to consider factors beyond glycated hemoglobin, and hypoglycemia in particular, when evaluating the safety and efficacy of medications for people with diabetes. Last fall, the FDA held a daylong meeting about the challenges of preventing severe hypoglycemia among older adults.

The purpose of Hypo-RESOLVE, which stands for Hypoglycemia—Redefining SOLutions for better liVEs, is to generate more data about the condition so that researchers and clinicians can better understand it, through studies that evaluate its underlying mechanisms, evaluate its cost, and ultimately come up with better ways to predict it so that it can be prevented. The project will also involve industry leaders from Abbott, Eli Lilly, Sanofi, and Medtronic; besides Denmark, representatives come from the United States, the United Kingdom, Switzerland, Italy, Germany, Austria, and Belgium.

“Our mission within Hypo-RESOLVE is to provide an evidence-based classification of hypoglycemia based on secure data from 100 to 150 recently conducted clinical trials,” Bastiaan de Galan, MD, PhD, coordinator of Hypo-RESOLVE and internist at the Department of Internal Medicine, said in a statement. Galan, who is with Radboud University Medical Center, in the Netherlands, said that developing better data on hypoglycemia would give researchers the “statistical power” to “make valid statements about the glucose thresholds below which hypoglycemia constitutes a great risk for people living with diabetes.”

Hypo-RESOLVE will include a Patient Advisory Committee to bring insights from people living with the disease into account as the project takes shape.

“Hypoglycemia presents a huge psychological burden for people with diabetes. We believe that the Patient Advisory Committee will help contribute to a better understanding of the disease’s impact on people with diabetes and ultimately help improve their lives,” Nam H. Cho, president of the International Diabetes Federation, said. “Through this project, we also hope to strengthen public awareness of hypoglycemia and diabetes generally.”