Diamedica Inc.

DM-71: Type 2 Diabetes

DM-71 is a combination of Bethanechol and N-Acetylcysteine (NAC). Bethanechol is typically prescribed to treat urinary retention disorders while NAC is used to treat acetaminophen toxicity following an overdose.

Preclinical studies demonstrate that neither compound alone improves insulin sensitivity to therapeutic levels. However, when combined, the two compounds act synergistically to restore insulin sensitivity levels to approximately 85%.

DiaMedica conducted a 12-week proof-of-concept phase IIa trial of DM-71, which had an absolute reduction of 0.32% (p=0.0066) from baseline of mean HbA1c in the evaluable population, and an absolute reduction of 0.55% (p=0.0063) from baseline in a pre-specified subgroup of patients with moderate and higher elevated HbA1c (≥8.0%). Furthermore, fructosamine levels continued to drop throughout the study suggesting that the drug could continue to have effect over longer periods (i.e. over 24 weeks).
 



 

In addition, the DM-71 trial showed statistically significant absolute weight reduction of 1.38 kg from baseline of mean weight per patient (p=0.0005).

The results of the study confirmed the safety and tolerability of DM-71 as there were no unexpected adverse events. Of particular importance, there were no serious adverse events in the study.