This Phase II trial, a randomized, double-blind, placebo-controlled, multiple dose study, will evaluate the efficacy and safety of three months of weekly injections of PC-DAC:Exendin-4 in patients with Type 2 diabetes not adequately controlled by metformin monotherapy. The trial will enroll 90 patients with 30 patients randomized to one of three parallel treatment groups: a 1.5mg fixed weekly dose group, a group receiving a 1.5mg weekly dose titrating to 2mg at the fifth week, and a placebo group.
A second Phase II trial is also planned which will be a randomized, double-blind, placebo-controlled, multiple dose study, to evaluate the efficacy and safety of three months treatment with PC-DAC:Exendin-4 in Type 2 diabetes patients not adequately controlled by metformin monotherapy. This trial is designed to explore the efficacy and safety profile of twice-weekly titration and maintenance dosing and is expected to begin later in the first quarter of 2008.