Clinical Trials and Drug Development in Diabetes

Clinical Trials and Drug Development in Diabetes will provide a comprehensive exploration of the scientific, regulatory, and clinical processes that drive the discovery and advancement of new therapies for diabetes care. With the global prevalence of diabetes—both Type 1 and Type 2 reaching epidemic proportions, the demand for innovative, effective, and safer treatments has never been greater. Clinical trials are the foundation of evidence-based medicine and are essential in evaluating the safety, efficacy, and long-term impact of new pharmacologic agents. Emphasis will be placed on regulatory requirements, ethical considerations, and trial design methodologies, including adaptive designs, real-world evidence models, and patient-reported outcomes. Attendees will gain insight into the critical endpoints commonly used in diabetes trials, such as HbA1c reduction, time-in-range, weight loss, cardiovascular and renal outcomes, and hypoglycemia incidence.A central focus of this session will be the development and evaluation of novel drug classes and combination therapies. Recent breakthroughs in diabetes pharmacotherapy include GLP-1 receptor agonists, SGLT2 inhibitors, and dual or triple agonists targeting multiple metabolic pathways. These agents not only improve glycemic control but also offer additional benefits such as cardiovascular protection, weight management, and renal health. In addition, updates will be shared on investigational therapies including GIP/GLP-1 dual agonists, oral insulin formulations, non-peptide small molecules, and gene and cell-based therapies.

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