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news.US-based DiaMedica has announced the beginning of its Phase I/II trial with first in human dosing of DM-199; a recombinant protein therapy for the treatment of diabetes and associated complications.
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The study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of DM-199 in 36 healthy volunteers and in 40 Type 2 diabetic patients.
Clinical & Regulatory Affairs vice president Mark Robbins said that the Phase I/II clinical trial will provide the opportunity to demonstrate the safety and potential biological activity of DM-199 in healthy volunteers and Type 2 diabetic patients during acute and longer-term use.
"With the promising pre-clinical insulin sensitization and secretagogue activity of DM-199, we are keen to assess the anti-diabetic activity in man," Robbins added.
DiaMedica chairman and CEO Rick Pauls said that the company looks forward to having the Phase I and single dose Phase II results from the Phase I/II clinical trial in the second half of 2013.