Final analysis of the study data confirmed the findings reported from the preliminary analysis announced October 1, 2007. In the 12-week study, DM-71 had an absolute reduction of 0.32% from baseline of mean HbA1c in the evaluable population, and an absolute reduction of 0.55% from baseline in a pre-specified subgroup of patients with moderate and higher elevated HbA1c (greater than or equal to 8.0%).
The study results also demonstrated a decrease from baseline in the mean values of ALT and AST at each of the visits in the DM-71 group. ALT and AST are enzymes commonly used to test for toxicity and an increase in the levels of these enzymes could indicate damage to body organs. The results of the study confirmed the safety and tolerability of DM-71 as there were no unexpected adverse events.
The company plans to confer with FDA in the first quarter of 2008 with the intention to initiate the next stage of human study in 2008. The upcoming study will also be expected to further elucidate the observed weight loss in the proof-of-concept study and demonstrate that longer duration results in further weight loss.
Karl-Gunnar Hidinger, president of DiaMedica, said: “Based on these results we will pursue further study of DM-71 in a large scale Phase IIb study measuring HbA1c over 24-30 weeks as expeditiously as possible. The design of the upcoming Phase IIb study will benefit greatly from our completed Phase II proof-of-concept study and recent studies in the area of type 2 diabetes.”