Semaglutide-Based Triple Therapy Protocol Proposed for Newly Diagnosed Type 2 Diabetes Remission

Type 2 Diabetes Mellitus (T2DM) often requires combination therapy, especially in newly diagnosed patients with high HbA1c. Current initial strategies aim for rapid glycemic control and, ideally, diabetes remission, but achieving sustained remission remains challenging. This study protocol addresses the need for optimized initial triple regimens, comparing a potent GLP-1 receptor agonist (GLP-1RA) with a DPP-4 inhibitor in combination with standard-of-care metformin and an SGLT2 inhibitor. The goal is to identify a superior approach for achieving and maintaining remission in this population.

This multicenter, randomized, controlled study proposes to enroll 240 newly diagnosed Type 2 Diabetes Mellitus patients (age 18-65, HbA1c ≥ 9.0%). Participants will be randomized into two groups for an 8-month treatment phase. The semaglutide group will receive 0.25 mg weekly (month 1), 0.5 mg weekly (month 2), then 1.0 mg weekly (months 3-8). The oral medication group will receive sitagliptin 0.1g daily. Both groups will concurrently receive metformin 1.0g daily and empagliflozin 10mg daily. Primary endpoints include HbA1c reduction, diabetes remission rate, and continuous glucose monitoring metrics.