Tirzepatide Versus Intensified Conventional Care After 2 Years of Treatment in Early Type 2 Diabetes

BACKGROUND: Initiation of treatment with tirzepatide, a once-weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GLP-1RA), early after a diagnosis of type 2 diabetes (T2D) may establish better and more durable glycemic control than current treatment approaches per guidelines and clinical practice. OBJECTIVE: To assess the efficacy and safety of tirzepatide versus intensified conventional care (ICC) in participants with early T2D who have inadequate glycemic control with diet, exercise, and metformin. DESIGN: Randomized, open-label, parallel-group, phase 4 trial (SURPASS-EARLY). (ClinicalTrials.gov: NCT05433584). SETTING: 78 sites in 10 countries. PARTICIPANTS: 794 adults with at most 4 years of T2D history treated with metformin. INTERVENTION: Tirzepatide (15 mg or maximum tolerated dose) or ICC (including GLP-1RAs but excluding tirzepatide) used in clinical practice and supported by local treatment guidelines. MEASUREMENTS: , weight, and waist circumference. RESULTS: <5.7%) with tirzepatide (60.2%) than ICC (24.0%). The most common adverse events were gastrointestinal in both groups. LIMITATION: Open-label design. CONCLUSION: <5.7%) with tirzepatide than ICC after 2 years. PRIMARY FUNDING SOURCE: Eli Lilly and Company.