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news.DiaMedica, a drug discovery and clinical development company, has received a no objection letter from Health Canada to initiate the second planned Phase II clinical trial investigating DM-71 in patients with type 2 diabetes.
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In the first Phase II trial, DM-71 showed statistically significant declines in HbA1c, fructosamine and weight with an excellent safety profile in humans, the company said.
This second trial is a randomized, cross-over, open-label study to test the effect of DM-71 on two metabolic markers, glucose and insulin, in a meal tolerance test and will enroll approximately 40 patients in Canada who have been diagnosed with type 2 diabetes. The entire study is expected to take approximately 16 weeks from enrollment of entry of first subject until last subject out following which data on the two primary endpoints will be reported.
Wayne Lautt, co-founder of DiaMedica, said: This trial is in follow-up to the positive Phase II study that demonstrated the ability of DM-71 to reduce HbA1c levels in humans. A single dose of bethanechol and N-acetyl cysteine was taken together one hour prior to a meal in the previous Phase II proof-of-concept study. The upcoming Phase II trial will include multiple doses and measure the efficacy of DM-71 when taken with a meal.