Biodel's BIOD-123 Achieves Primary Endpoint in Phase 2 Type 1 Diabetes Clinical Trial
Biodel Inc. (NASDAQ: BIOD) today announced preliminary results from Study 3-201, a Phase 2 clinical study of BIOD-123, an investigational ultra-rapid-acting mealtime insulin, in patients with type 1 diabetes. BIOD-123 achieved the primary endpoint of non-inferiority for HbA1c relative to insulin lispro, a widely prescribed rapid acting mealtime insulin analog marketed as Humalog®.
Compared to Humalog®, BIOD-123 demonstrated:
Achievement of primary efficacy endpoint; demonstration of non-inferiority in change from baseline HbA1c
Comparable weight gain, mean hypoglycemia event rates and postprandial glucose excursions over the entire treatment period with some notable trends in favor of BIOD-123 in weight gain during the stable dosing period, median hypoglycemia event rates and postprandial glucose excursions to a liquid meal challenge test
Comparable safety and adverse event profiles with the exception of an increased frequency of injection site pain associated with BIOD-123 which appears to be clinically minor, was short-lived and did not result in patient dropouts