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DiaMedica today announces top-line results of a Phase II trial showing that its investigational drug DM-83 met the primary endpoint by lowering peak insulin levels in diabetic patients
WINNIPEG, MANITOBA, CANADA | July 14, 2008 | DiaMedica Inc. (TSX VENTURE:DMA) ("DiaMedica"), a drug discovery and development company focused on novel treatments for Type 2 diabetes, today announces top-line results of a Phase II trial showing that its investigational drug DM-83 met the primary endpoint by lowering peak insulin levels in diabetic patients. The single dose, placebo controlled, single-blind, cross-over study in patients with Type 2 diabetes, using a meal tolerance model showed a statistically significant reduction (23%) of insulin compared to placebo (p equals 0.0064). Peak changes in glucose levels were not statistically different between the two groups (p equals 0.2). There were no adverse events or observed side effects in the treatment group and DM-83 was well tolerated in this trial.
The Phase II trial was conducted in the European Union and was designed to demonstrate DM-83's effect on postprandial glucose and/or insulin levels in 20 Type 2 diabetics after they consumed a single standard meal (the study's primary endpoint). Each patient in this crossover study was administered DM-83 as well as the placebo and therefore served as their own control. All patients maintained concurrent therapeutic treatments during the course of this Phase II trial including diabetes medications used to stabilize glucose levels.
"The effect of DM-83 in the Phase II trial, given in a single dose, one hour before consuming a liquid test meal, is consistent with our extensive basic preclinical research related to this novel discovery. We believe that the fundamental metabolic problem a diabetic has is the processing of nutrients within a meal. Our technology targets a dysfunctional nerve signal from the brain to the liver in Type 2 diabetic patients. DM-83 was designed to provide a dual signal to the liver which results in reversal of the abnormal meal processing", stated Dr. Wayne Lautt, Chief Scientific Officer, DiaMedica, Inc. "This study demonstrated with statistical significance, the ability of DM-83 to reduce the amount of peak insulin required to process glucose."
"We are encouraged by the positive result of this clinical study showing that DM-83 reduced insulin levels and was well tolerated", stated Rick Pauls, President & CEO, DiaMedica Inc. "This trial provided further support for DiaMedica's new approach to the treatment of diabetes. The results of this proof of concept study also supports the treatment approach of our lead product, DM-71, which demonstrated the ability to lower HbA1c, fructosamine and weight in a 12 week Phase II study completed in late 2007. DiaMedica is committed to advancing the development of our nerve signaling treatments for patients affected by Type 2 diabetes. We look forward to completing a full data analysis of the trial results."
About DM-83
DM-83 has demonstrated the ability to restore insulin sensitivity in a Type 2 diabetes animal model. The product is a novel combination of two known compounds with well established safety profiles that are used to treat other unrelated human conditions, one of which is to improve cardiovascular conditions. Neither compound has been shown to restore insulin sensitivity on its own, while combining the two results in a synergistic effect that restores insulin sensitivity to near prediabetic levels. DiaMedica is currently pursuing patent protection for new chemical entities based on its previous research of the mechanism of DM-83.
About DiaMedica
DiaMedica is a biotechnology company developing novel treatments for various stages of Type 2 diabetes with three clinical stage products. The Company's lead product, DM-71, demonstrated the ability to reduce HbA1c levels and weight in a Phase IIa human trial. DM-83 showed efficacy in reducing insulin levels in a Phase IIa meal tolerance test. DiaMedica's third clinical stage product is entering a Phase IIa trial in the second half of 2008. DiaMedica is traded under the symbol "DMA" on the Toronto Stock Venture Exchange. For additional information please visit the Company's website at www.diamedica.com.
SOURCE: DiaMedica Inc. |
