Diasome Pharmaceuticals, Inc., a company developing hepatocyte directed vesicle (HDV) technology that can be added to any insulin to improve blood glucose control for people living with diabetes, today announced the completion of patient enrollment in its Phase 2 OPTI-1 study of injectable HDV plus insulin for the treatment of type 1 diabetes. A total of 61 patients were enrolled at eight sites in the U.S.
“The completion of patient enrollment in this clinical trial marks an important milestone for the continued development of HDV as a liver targeting system for insulin,” said Robert Geho, chief executive officer of Diasome. “We are committed to providing an effective treatment option to people with type 1 diabetes that eases their constant worry of blood sugar highs and lows. We look forward to gaining additional dosing insights about mealtime liver targeted insulin therapy and to reporting top line data from this study in the coming months.”
“The completion of patient enrollment in this clinical trial marks an important milestone for the continued development of HDV as a liver targeting system for insulin,”
OPTI-1 is an open-label, multicenter study to evaluate the effect of HDV added to rapid-acting insulin on HbA1c, hypoglycemia, and bolus and basal insulin dosing in adult type 1 diabetes subjects whose starting HbA1c levels are between 6.5% and 8.5%. Subjects will undergo a three-month run-in period on standard of care therapy followed by three months of treatment with HDV plus insulin in conjunction with optimized long-acting insulin dosing rates.