A Means to an Endpoint—Establishing Meaningful Outcomes in Clinical Neuropathy Trials
Monday, June 24, at 8:00 a.m. ET
Room W206
Orange County Convention Center
Meaningful Endpoints in Clinical Trials—Lessons Learned
Rodica Busui, MD, PhD
Larry D. Soderquist Professor of Diabetes, Metabolism, Endocrinology, Internal Medicine,
University of Michigan
What is your presentation about?
I will discuss lessons learned on the design and main outcomes selection for diabetic neuropathy and their impact on the landscape for developing effective disease-modifying and neuropathic pain therapies for people with diabetes who are affected by these very prevalent and challenging complications, including data from recent trials.
How do you hope your presentation will impact diabetes research or care?
Diabetic neuropathy and associated neuropathic pain are one of the most prevalent and invalidating diabetes complications for both people with type 1 and type 2 diabetes, with direct impact on loss of sensation, with subsequent increase risk for falls, fractures, loss of daily function, severe pain that is very challenging to treat, leading to anxiety, depression, sleep deprivation, polypharmacy and associated side effects, including dependence. It is also the leading cause of foot ulcers and amputations, and an independent predictor of mortality in people with diabetes. Unfortunately, to date, these remain orphan complications, given the lack of disease-modifying therapies and mostly ineffective pain reduction agents. Thus, using the knowledge learned from these lessons is critical to advance the field, engage pharma, and develop safe and effective therapeutic strategies
How did you become involved with this area of diabetes research or care?
See above. I have dedicated my career to fighting all complications of diabetes, and helping people with diabetes live a better life.