DGD Research of San Antonio has begun screening patients in a Phase IIa, controlled US clinical trial measuring efficacy (using the gold-standard euglycemic-hyperinsulinemic clamping procedure), as well as pharmacokinetic parameters, safety and tolerability of AKP-020 in diabetic patients.
Jay Lichter, president and CEO of Akesis, said: “We are extremely pleased to have received clearance for investigational new drug (IND)application and guidance from the FDA to begin our clinical study with AKP-020. Our development program is on schedule, and we expect to dose our first patient before the end of 2007.”