UNC School of Medicine researchers, in collaboration with Diasome Pharmaceuticals, Inc., have released results from a Phase 2b clinical trial pointing to a promising new approach for treating type 1 diabetes. The OPTI‑2 study found that HDV‑Lispro, a novel liver‑targeted insulin, maintained equivalent blood glucose control compared to standard insulin while meaningfully reducing the risk of hypoglycemia, dangerously low blood sugar.
"Insulin therapy has always had a narrow therapeutic index: tighter glycemic control directly correlates with increased risk of hypoglycemia. This tradeoff continues to be a major challenge for people living with type 1 diabetes," said Klara Klein, MD, PhD, assistant professor of medicine, University of North Carolina School of Medicine, and principal investigator in the trial. "In OPTI-2, we see potential to decouple glycemic control from hypoglycemia risk. People randomized to HDV-LIS met similar A1C targets but experienced fewer hypoglycemic events and no severe hypoglycemic events. If confirmed in larger studies, this could allow people living with T1D to achieve glycemic targets with less concern about clinically meaningful hypoglycemia."
Nearly 2.1 million Americans live with type 1 diabetes, and managing fluctuating blood sugar is a constant and critical part of daily life. Even with careful monitoring, many experience dangerous highs and lows that affect both short-term safety and long-term health. Researchers hope these findings could ultimately lead to meaningful improvements in quality of life and long-term outcomes for people living with the disease.
"People living with type 1 diabetes are constantly walking a tightrope between hyperglycemia (high blood glucose) and hypoglycemia (low blood glucose)," said Klein. "If these findings are confirmed, HDV-Lispro could allow people living with type 1 diabetes to achieve the tight control needed to reduce long-term complications without as much fear of acute, severe, and life-threatening hypoglycemia. Reducing hypoglycemia while maintaining glycemic control would be a major advance in diabetes care."
Klein notes that larger studies are needed to confirm the positive impact of this treatment, including across different insulin pump systems. She adds that if future trials validate these results, HDV-Lispro could become an important new option for people living with type 1 diabetes.
