The primary endpoint of the study is change in glycated hemoglobin (HbA1c) between placebo and treatment groups. The study is also evaluating effects on metabolic and liver function markers, such as cholesterol, fasting glucose, fasting insulin, free fatty acids and body mass index, as secondary endpoints. The company expects to present the results of the study in the second half of 2007.
The product, DM-71, has demonstrated the ability to restore insulin sensitivity in a type 2 diabetes animal model. The product is a combination of two known drugs with well established safety profiles that are used to treat other unrelated human conditions. These two molecules act synergistically to address a new target in the treatment of diabetes. DiaMedica commented that as both components of DM-71 have been approved for human use, it has been able to advance the product directly into a phase II clinical trial.