Real World Evidences and Identifying the Gaps and Future Prospects with Incretin Therapy in India

This chapter examines the complementary roles of randomized controlled trials (RCTs) and real-world evidence (RWE) in defining the clinical utility of semaglutide and broader incretin therapy, with a particular focus on India. While RCTs establish efficacy and safety under controlled conditions, RWE provides critical insights into effectiveness, adherence, heterogeneity of response, and implementation barriers in routine practice. The chapter integrates data from the Peptide Innovation for Early Diabetes Treatment (PIONEER) RCT program, PIONEER REAL studies, SURE studies, and Semaglutide 2.4 mg Clinical Outcomes in Patients with Obesity in Real-World Evaluation, together with emerging Indian experience, to compare glycemic, weight, and cardiometabolic outcomes across trial and practice settings. Across these datasets, semaglutide demonstrates consistent reductions in HbA1c and body weight, with real-world studies often showing clinically meaningful effectiveness across heterogeneous populations. The chapter also highlights translational gaps relevant to India, including limited subgroup-specific evidence (e.g., PCOS, hypothyroidism, and insulin-treated populations), variation in counseling and follow-up, limited rural representation, and the need for cost-effectiveness data in the Indian context. Overall, the chapter supports a combined RCT-plus-RWE approach in which semaglutide evidence is interpreted not only through efficacy endpoints but also through real-world feasibility, credibility, and scalability to strengthen incretin-based care in India.