Mock Phase III Clinical Trial Protocol for Glycurex in Type 2 Diabetes Mellitus

This project is a simulated clinical trial protocol prepared as part of academic training in the PharmD program. It describes a double-blind, randomized, placebo-controlled Phase III trial investigating Glycurex, a hypothetical antidiabetic agent, in patients with Type 2 Diabetes Mellitus. Developed using ICH-GCP structure and regulatory practices, the project showcases trial design, safety monitoring, endpoints, and ethical considerations. Author: Sakshee Hemant DesaleInstitution: Dr. D.Y. Patil Dnyan Prasad University