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news.Patients receiving DM-99, showed a decrease in baseline adjusted peak blood glucose concentration of 19%
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DiaMedica, a drug discovery and development company, has reported top-line results of a proof-of-concept Phase IIa trial for DM-99, the company’s third drug in clinical development for type 2 diabetes.
The single dose, placebo controlled, single-blind, crossover trial studying 40 patients with type 2 diabetes examined the effect of DM-99 or placebo treatment on plasma glucose and insulin levels after a meal tolerance test. Those patients receiving oral anti-diabetes medications used to stabilize glucose levels continued treatment during the study. During statistical analysis a sequence effect between period 1 and period 2 was observed in this crossover study leaving overall results inconclusive.
The underlying cause of this effect is under investigation. Consistent with standard crossover study design upon detection of a sequence effect, the statistical analysis plan was predefined to revert to period 1 results where 20 subjects receiving DM-99 and 20 subjects receiving placebo were both trial and treatment naive.
According to the company, the trial was powered to demonstrate a therapeutically significant effect defined as a p less than 0.2 with an absolute decrease of at least 10% in glucose and/or insulin. Patients receiving DM-99 in period 1 showed a decrease in baseline adjusted peak blood glucose concentration of 19% (p equals 0.077) versus those receiving placebo.
Patients receiving DM-99 in period 1 showed a decrease in incremental glucose area under the curve 0-240 minutes of 31% (p equals 0.030) versus those receiving placebo. DM-99 was safe and well tolerated with only one report of mild nausea that was considered unlikely related to treatment, the company said.
Reggie Bowerman, president and CEO of DiaMedica, said: We are encouraged by the result from this exploratory clinical study along with the results of prior DM-99 preclinical data. Our goal was to see a positive trend indicated by changes in blood glucose in type 2 diabetes patients after they have consumed a meal. We believe the results from this proof-of-concept trial support our continued development of the DM-99 program.