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Discussing the results of a phase 2 study from Diasome examining use of HDV-insulin in type 1 diabetics.
Results of a phase 2 study suggested the use of Hepatic Directed Vesicle (HDV)-insulin could help reduce this incidence of hypoglycemia, including nocturnal hypoglycemia without increasing HbA1c.
Presented at the American Diabetes Association’s (ADA) 80th Scientific Sessions, the phase 2 OPTI-1 study suggests HDV-insulin from Diasome could help revolutionize hypoglycemic management in type 1 diabetics.
Designed as a 6-month open-label study, patients included in the study underwent a 90-day run-in phase with insulin lispro/ insulin degludec and continuous glucose monitoring followed by a 90-day treatment period with HDV-insulin along with -10% or -40% basal dose to encourage titration with HDV-insulin as well as continuous glucose monitoring.
Of the 61 patients included, the mean baseline HbA1c was 7.3%. After the first 90 days, HbA1c had been lowered to 6.9% and, at the end of the HDV-insulin period, HbA1c was 7.0%.
At baseline, participants experienced 1.11 hypoglycemic events per week. At 3 months, this decreased by 11% to 0.99 events per week and further decreased by an additional 20% after switching from insulin lispro and events decreased to 0.80 per week by study end (P=.18; 0.86 daytime events and 0.75 nighttime events per week).
To learn more about the potential of HDV-insulin, HCPLive® caught up with Marc Penn, MD, PhD, chief medical officer with Diasome, to discuss the results of the phase 2 OPTI-1 study in a recent HCPLive House Call.
This study, “Hepatic Insulin Delivery to Minimize Hypoglycemic Events in Persons with Type 1 Diabetes: The OPTI-1 Study,” was presented at ADA 2020.