T_Dia
04-03-2009, 03:34 PM
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.
Full Article (http://drugdiscovery.pharmaceutical-business-review.com/news/diamedica_reports_top_line_results_from_phase_iia_ diabetes_trial_030409).
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.
Full Article (http://drugdiscovery.pharmaceutical-business-review.com/news/diamedica_reports_top_line_results_from_phase_iia_ diabetes_trial_030409).