Diasome Pharmaceuticals announced positive results this week from a Phase 2 study of its injectable hepatocyte directed vesicle (HDV) additive for insulin in patients with type 1 diabetes. The news could prove a major step forward for therapies that aim to improve and optimize the way insulin is used and metabolized by the body.
In a healthy body, the pancreas’ islet cells secrete insulin, which then facilitates the uptake of glucose into other cells throughout the system. Insulin also stimulates the storage of glucose – in the form of glycogen – by the liver. Most people with type 1 diabetes have become intimately familiar with the delicate balance between carbohydrate consumption and insulin dosing, trying to replicate this natural function with shots, snacks, exercise, and medication.
The essential concept behind HDV is the use of nanometer-scale vesicles, or microscopic storage discs, to transport injectable insulin to the liver. By mediating the metabolizing of insulin through the natural processing in that organ, Diasome aims to optimize the insulin dosing process.
Reducing hypoglycemia and improving outcomes
The 24-week, open-label trial looked at a randomized patient group using a combination of fast-acting insulin Lispro (such as Humalog) and long-acting insulin Degludec (such as Tresiba). A portion of the patients then added HDV to their insulin dosing while a control group had no additives.
“The OPTI-1 study may be the first clinical trial to demonstrate the impact of the combined effects of liver targeted insulin and physiologically driven changes in the ratio of mealtime to long-acting insulin regimens,” trial investigator Bruce Bode, a diabetes specialist with Atlanta Diabetes Associates and clinical associate professor at Emory University, said in a press release.
“When added to insulin, HDV may allow patients to optimize the amount of short-acting and long-acting insulin they need to reduce the incidence of hypoglycemia while still achieving positive long-term health outcomes.”
While research and attention for people with type 1 diabetes often understandably focuses on the pancreas, an increasing number of investigators are now taking a more holistic approach to treating and even exploiting the body’s systems to better manage the condition.
“Results from this study, which we plan to present at upcoming conferences, continue to support the hypothesis that improved mealtime insulin delivery to the liver should have an important and positive effect on overall glycemic control,” said Robert Geho, Diasome’s chief executive officer.