Biodel announced that an independent investigator initiated a pump trial of Biodel’s two ultra-rapid-acting formulations of recombinant human insulin. Biodel’s formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed mealtime insulin analogs.
This study is designed as a double blinded, three-period cross over trial in which insulin pumps will be used to deliver BIOD-105, BIOD-107 and Humalog each at separate dosing visits in approximately 8 patients with type 1 diabetes. This study, expected to be completed in the fourth calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and injection site tolerability profiles of BIOD-105 and BIOD-107 relative to that of Humalog. Drs. W. Kenneth Ward and Jessica Castle of the Division of Endocrinology, Diabetes, and Clinical Nutrition at Oregon Health and Sciences University will serve as principal investigators for this trial.
Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is used as a means to provide intensive insulin therapy to patients with diabetes. Currently available prandial insulins are used in pumps, but often are not absorbed rapidly enough to achieve optimal mealtime glucose control. It is believed that an ultra-rapid-acting insulin will be better suited for pump therapy than currently marketed mealtime insulin analogs.