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In an independently conducted study, chronic administration of DM-204 prevented disease progression within an in vivo Type 2 diabetes model. Type 2 diabetics is a metabolic disorder that is characterized by high blood glucose levels, due to insulin resistance or insulin deficiency, usually brought on by other conditions such as obesity.
The disease is often initially managed by increasing exercise and dietary modification, but if the condition progresses, insulin injections or oral medication may be necessary.
Treatment with DM-204 resulted in statistically significant lower mean differences compared to untreated animals after 21 days for the following parameters: 2.6 percent lower HbA1c levels at day 21; 70 percent lower difference in fasting blood glucose levels; 25 mm/Hg lower difference in systolic blood pressure levels and less than 20 percent improvement in total cholesterol levels.
Managing each of these parameters is important in the treatment of patients suffering from Type 2 diabetes. An HbA1c test measures a person's average blood sugar levels over a period of three months.
DiaMedica's Scientific Advisory Board member, Dr. John Amatruda, said: "These results are very encouraging and provide a strong foundation with which to move DM-204 forward."
DiaMedica's vice president of research, Dr. Mark Williams, added: "DM-204 has the opportunity to fundamentally change the treatment regimen for Type 2 diabetes patients with hypertension and high cholesterol.
"DM-204 could potentially become the single long-acting treatment by virtue of being a monoclonal antibody therapy. The chronic in vivo model data shows DM-204's ability to prevent disease progression of Type 2 diabetes and increased blood pressure."
Reduction in HbA1c is the critical endpoint measurement in receiving regulatory approval for a Type 2 diabetes medication.
Approximately 70 percent of Type 2 diabetics are prescribed antihypertensive medication to control blood pressure and prevent heart disease and stroke.
The antihypertensive and cholesterol-lowering ability of DM-204 may significantly reduce the need for such medication(s), and furthermore protect Type 2 diabetics from heart disease and stroke complications.
Administration of DM-204 was also well-tolerated and outperformed marketed Type 2 diabetes drugs sitagliptin (known as Januvia) and exenatide (known as Byetta), the company said.
The full results are to be published and presented in 2012.