Abvance Therapeutics announced the presentation of groundbreaking human clinical data at the 85th Scientific Sessions of the American Diabetes Association (ADA) in Chicago, marking the first human study to evaluate fixed-ratio co-administration of insulin and glucagon in a mealtime setting for Type 1 diabetes patients.
Novel Approach to Hypoglycemia Prevention
The study, titled "Uncovering the bidirectional glucose-dependent relationship of insulin and glucagon: a meal-challenge study in patients with Type 1 diabetes," was presented by Dr. Guillaume Kraft, Research Assistant Professor at Vanderbilt University. The research examined how insulin and glucagon behave when delivered together in a fixed ratio at mealtime in people with Type 1 diabetes.
The clinical trial was led by Dr. Bruce Bode and his team at Atlanta Diabetes Associates, involving 15 participants with Type 1 diabetes under closely monitored conditions. The results suggested that combining glucagon with insulin at a single fixed ratio at mealtime may offer protection against hypoglycemia during the post-meal drop in blood sugar without interfering with key metabolic processes.
Building on Preclinical Foundations
The human study builds on earlier preclinical research at Vanderbilt University, where scientists observed that insulin and glucagon might interact differently depending on a person's blood sugar level. In that preclinical work, the hormones appeared to shift in dominance—insulin having a stronger effect when glucose was high, and glucagon becoming more influential when glucose was low.
This human study explored whether similar patterns could be seen when the two hormones were given together in a single fixed ratio at mealtime to people with Type 1 diabetes, translating the preclinical observations into clinical practice.
Safety and Tolerability Profile
The combination therapy demonstrated a favorable safety profile in the study participants. The treatment was well tolerated and showed no interference with key metabolic processes, addressing a critical concern in diabetes management where maintaining metabolic balance is essential.
"This study provides early human insight into how carefully designed glucagon-insulin combinations may offer a new tool for improving the day-to-day safety of intensive insulin therapy," said Dr. David Maggs, co-founder of Abvance Therapeutics.
Clinical Significance and Future Directions
The results offer early support for Abvance's approach to rationally engineered glucagon analogs and represent a significant milestone in diabetes therapeutics. Dr. Maggs expressed gratitude to the research teams, stating, "We are grateful to Dr. Kraft and the research team at Vanderbilt, and to Dr. Bode and his team in Atlanta, for advancing this important translational work."
Abvance Therapeutics, a privately held biotechnology company founded on research from Vanderbilt University, is advancing novel glucagon-based therapies designed to integrate into the lived experience of diabetes care. The company is led by a team with expertise in diabetes therapeutics, drug development, and health technology.
"Abvance is excited to build on this foundational work as we advance our pipeline of glucagon-based therapies designed to integrate seamlessly into real-world treatment strategies," added Maggs, indicating the company's commitment to developing practical solutions for diabetes management.