Biodel completes dosing in Phase II trial of diabetes drug

The open label, parallel group study had randomized 132 type 1 diabetes patients with either BIOD-123 or Humalog to use as their mealtime insulin during a treatment period of 18 weeks.

Insulin glargine, sold as Lantus, as the basal insulin is used in both the arms.

The study’s primary endpoint is to evaluate HbA1c control and secondary endpoints include postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.

Biodel president and chief executive officer Dr Errol De Souza said, "Completing the BIOD-123 Phase 2 clinical trial is another significant milestone in the development of novel ultra-rapid-acting mealtime insulins to aid patients and healthcare professionals in the treatment of diabetes."

Top-line results are expected by the end of the current quarter.