According to Rick Pauls, DiaMedica’s interim president and CEO, the 20 patient single-blind trial will demonstrate DM-83’s level of effectiveness in controlling blood glucose and insulin levels in Type 2 diabetic patients after they have consumed a standard meal. Changes in insulin and glucose levels are the study’s primary endpoints.
Each patient will test both the effects of DM-83 as well as a placebo and therefore serve as their own control in this crossover study. All patients have now completed treatment and last patient is expect to complete the study in the second quarter with results to be analyzed and released shortly thereafter. The results of this trial will be used to optimize the design of the next stage of clinical development for DM-83.
DiaMedica believes that restoring insulin sensitivity and allowing the body to use its own naturally produced insulin is the key to combating Type 2 diabetes. Preclinical animal studies have demonstrated that DM-83 is able to restore insulin sensitivity to near pre-diabetic levels and has been shown to be safe.