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news.DiaMedica has reported top-line results of a Phase II trial showing that its investigational drug DM-83 met the primary endpoint by lowering peak insulin levels in diabetic patients.
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The single dose, placebo controlled, single-blind, cross-over study in patients with Type 2 diabetes, using a meal tolerance model showed a statistically significant reduction (23%) of insulin compared to placebo (p=0.0064). Peak changes in glucose levels were not statistically different between the two groups (p=0.2).
The Phase II trial was conducted in the EU and was designed to demonstrate DM-83’s effect on postprandial glucose or insulin levels in 20 Type 2 diabetics after they consumed a single standard meal (the study’s primary endpoint).
Each patient in this crossover study was administered DM-83 as well as the placebo and therefore served as their own control. All patients maintained concurrent therapeutic treatments during the course of this Phase II trial including diabetes medications used to stabilize glucose levels.
Wayne Lautt, chief scientific officer of DiaMedica, said: “This study demonstrated with statistical significance, the ability of DM-83 to reduce the amount of peak insulin required to process glucose.”