Kathryn J. Lucas, M.D. – FDA EIR, May 22, 2015

An FDA inspection was conducted at Kathryn Lucas, M.D., Diabetes and Endocrinology, located in Morehead City, NC, from May 18 to May 22, 2015. This high-priority, for-cause clinical investigator data validation inspection was initiated in response to a complaint and performed under the regulatory framework of CP7348.811, specific to Clinical Investigators. The inspection reviewed two studies, including Novo Nordisk Protocol EX1250-4080, which focused on the cardiovascular safety of insulin degludec versus insulin glargine in type 2 diabetes patients.The inspection revealed several significant deviations from regulatory requirements and study protocols. Key issues included the randomization of subjects who were ineligible for the study, failure to document blood pressure readings as specified by the protocol, and the improper initiation of rescue therapy. Furthermore, discrepancies were found between the source data and the Case Report Forms, and there were instances of unreported adverse events and concomitant medications. Following the inspection, an FDA Form 483, detailing these observations, was issued to Dr. Kathryn Lucas, indicating the need for corrective actions to address the identified deficiencies in clinical trial conduct and data integrity.