At the current time there is no effective disease modifying therapy for diabetic neuropathy
(DN). The proposed study design employs a quantifiable early measure of DN, intraepidermal
nerve fiber density (IENFD), allowing for accurate assessment of actual nerve fiber density.
Preclinical data supports the use of Niagen®
(3-(Aminocarbonyl)-1-β-D-ribofuranosyl-pyridinium chloride - NR) as a potential therapy for
diabetic neuropathy. Phase I data indicates safety in humans. This study seeks to investigate
the use of Niagen® (NR) as a potential treatment for diabetic neuropathy in subjects with
type 2 diabetes mellitus or impaired glucose tolerance over a 6 month period. The endpoint
measures in addition to the IENFD with determine changes in clinical and electrophysiological
outcomes, quality of life and biochemical measures.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore