International research project to investigate effect of hypoglycemia

An international consortium of 23 institutions and organizations will launch a research project to gather data on the effects of hypoglycemia on diabetes, according to a press release from Novo Nordisk, a project participant.

The research project, Hypo-RESOLVE, is designed to provide researchers and clinicians with more validated data on hypoglycemia by creating a sustainable clinical database, conducting studies to understand the underlying mechanisms of hypoglycemia, conduct statistical analyses to define predictors and consequences of hypoglycemia, and calculate its financial cost in European countries.

“Our mission with 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 in the department of internal medicine at Radboud University Medical Center, the Netherlands, said in the release. “With this statistical power, we will be able to make valid statements about the glucose thresholds below which hypoglycemia constitutes a great risk for people living with diabetes.”

The effort will also include a patient advisory committee, incorporating patient opinions across all components of the project, according to the release. The project is supported with 26.8 million euros from the Innovative Medicines Initiative, a joint undertaking of the European Commission and the European Federation of Pharmaceutical Industries and Associations, JDRF and the Leona M. and Harry B. Helmsley Charitable Trust.

In December, stakeholders in the type 1 diabetes community recommended the use of standardized definitions for several diabetes outcome measurements beyond HbA1c, including hypoglycemia, with the goal of including such outcomes in research for future therapies. As Endocrine Today previously reported, the report, produced by the Type 1 Diabetes Outcomes Program, defined three levels of hypoglycemia:

level 1, defined as a measurable glucose concentration of less than 70 mg/dL but greater than 54 mg/dL;

level 2, defined as a glucose measurement of less than 54 mg/dL; and

level 3, defined as a “severe event characterized by altered medical and/or physical status requiring assistance.”

“This consortium beings together world leaders from the field of diabetes to reduce the burden of hypoglycemia,” Stephen Gough, MD, global chief medical officer of Novo Nordisk, said in the release. “Hypo-RESOLVE paves the way for further research on glucose-lowering interventions that will serve people living with diabetes, clinicians and health care companies.”

The project is scheduled to launch with a first meeting in Denmark on May 16-17. – by Regina Schaffer