Last patient out in the phase IIa proof of concept clinical trial of DM-99
WINNIPEG, Manitoba – February 10, 2009 – DiaMedica Inc. (TSX-V:DMA), a drug discovery and clinical development company focused on a novel approach to treating type 2 diabetes, today announces last patient out in the phase IIa proof of concept clinical trial of DM-99.
The 40 patient single-blinded clinical trial was conducted in the European Union. It was designed to demonstrate DM-99’s effectiveness at changing blood glucose levels in patients diagnosed with type 2 diabetes, after they consumed a standardized meal. Change in insulin and/or blood glucose levels was the study’s primary endpoint. Each patient was tested for both the effects of treatment with DM-99 and a placebo, and therefore served as their own control in this cross over study. Pre-clinical animal studies on DM-99 were performed by Dr. David Wasserman, Professor of Molecular Physiology and Biophysics and Ron Santo Chair in Diabetes at the Diabetes Research and Training Center at Vanderbilt University in Nashville, Tennessee. The amount of glucose being metabolized was measured using the hyperinsulinemic euglycemic clamp model, the gold standard method for quantifying insulin resistance. Specifically, healthy animals treated with DM-99 were able to metabolize 41% more glucose than untreated healthy animals (p<0.04) within the first sixty minutes of the drug being administered. The drug was also shown to have a very good safety profile.“We believe that DM-99 may both insulin sensitize and hasten the onset of insulin action”, commented Mr. Reginald Bowerman, DiaMedica’s President and CEO. “We look forward to the outcome of this phase II trial in light of the compelling pre-clinical research results.”
Diabetes is a widespread and rapidly growing disease, affecting over 180 million people world wide with over 90% of people with diabetes being diagnosed with the type 2 form. According to the World Health Organization, this number is expected to double during the next 15 years while the American Diabetes Association has estimated the annual economic cost in 2007 to the United States to be $174 billion with over 8% of the population having this disease. Global sales of drugs for type 2 diabetes currently total $8 billion per year and are expected to climb to $12 billion per year by 2011. About DM-99 Pre-clinical results from the Diabetes Research and Training Center at Vanderbilt University have shown that DM-99 is able to cause tissue to increase the uptake of glucose from the blood by over 40% (p<0.04) within 60 minutes of being injected. DM-199, a 40x more biologically active version of DM-99, has been created and will soon undergo pre-clinical testing.
About DiaMedica
DiaMedica is developing novel treatments for type 2 diabetes based on a newly discovered ‘nerve reflex’ mechanism for which the Company has been issued two U.S. patents. DiaMedica completed a successful phase II trial with its lead product, DM-71, which demonstrated the ability to reduce HbA1c (blood sugar) levels and weight in humans. DiaMedica also completed a successful phase II trial with its second compound, DM-83, designed to measure changes in insulin and glucose. The success of this clinical trial was highly significant as DiaMedica believes it validates the novel ‘nerve reflex’ mechanism that would designate the Company’s drugs as first-in-class. The Company’s third drug in clinical development, DM-99, will complete a phase II trial in Q1 2009. Preclinical results from Vanderbilt University have shown that DM-99 is able to cause tissue to increase its uptake of sugar from the blood by over 40% (p<0.001) during the first 60 minutes of treatment. DM-199, a 40x more biologically active version of DM-99, has been created with the expectation that it will be developed into a once-a-week injection. DiaMedica has been recognized as one of the Top Ten™ Life Science companies in Canada for the past two years by the Ottawa Centre for Research and Innovation.
For more information, please contact: Kevin Richardson, Ph.D.
DiaMedica Inc.
Phone: 204.478.5605
Fax: 204.453.3745
krichardson@diamedica.com
www.diamedica.com
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| Symbol | Last | Change |
|---|---|---|
| DMA.V | 1.43 | 0.00 |

