This study is designed to compare glycemic control of a standardized liquid meal challenge and insulin pharmacokinetics (PK) after administration of each of four study drugs: Humulin R with and without rHuPH20 and Humalog with and without rHuPH20.
This exploratory, crossover design, single blind, open label, liquid meal Phase II study is designed to collect data on at least 20 patients who complete the study. The study allows for insulin dose titration and each patient will receive a minimum of four and up to three additional study drug injections that include Humalog and Humulin R with and without rHuPH20. Study drug will be injected subcutaneously into the abdomen immediately prior to ingestion of a standardized liquid meal.
The primary endpoint, a PK measure, will be the area under the curve for plasma insulin concentration from zero to 60 minutes after injection. Secondary endpoints will include additional PK data, as well as blood glucose concentration at various time points.
Jonathan Lim, president and CEO of Halozyme, said: “We are proud to begin this Phase II clinical trial in our insulin program and believe this study will provide valuable insight into how the co-administration of our rHuPH20 enzyme with two currently available insulin products could lead to significant patient benefits such as better glycemic control, less hypoglycemia, and more convenient injection timing.”