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Therapeutic efficacy of Semaglutide

1. Overview of Clinical Studies

Semaglutide tablets have been studied in patients with type 2 diabetes as monotherapy and in combination with metformin, sulfonylureas, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, insulin, and thiazolidinediones. The efficacy of semaglutide tablets has been compared with placebo, empagliflozin, sitagliptin, and liraglutide. Semaglutide tablets have also been studied in patients with type 2 diabetes and mild and moderate renal impairment.

In patients with type 2 diabetes, semaglutide tablets produced clinically meaningful reductions in HbA1c from baseline compared with placebo.

The effectiveness of semaglutide tablets (R2 formulation - 1.5 mg, 4 mg, and 9 mg strengths) and semaglutide tablets (R1 formulation - 3 mg, 7 mg, and 14 mg strengths), as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, has been established based on adequate and well-controlled studies of semaglutide tablets (R1 formulation) in adults with type 2 diabetes. The following are efficacy results from adequate and well-controlled studies of semaglutide tablets (R1 formulation) in adults with type 2 diabetes.

The efficacy of semaglutide tablets was not affected by baseline age, sex, race, ethnicity, BMI, body weight, duration of diabetes, and degree of renal impairment.

2. Semaglutide Tablets as Monotherapy in Patients with Type 2 Diabetes

In a 26-week double-blind trial (Trial 1), 703 adults with type 2 diabetes inadequately controlled with diet and exercise were randomized to semaglutide tablets 3 mg, semaglutide tablets 7 mg, or semaglutide tablets 14 mg once daily or placebo. Patients had a mean age of 55 years, and 51% were male. The mean duration of type 2 diabetes was 3.5 years, and mean BMI was 32 kg/m². Overall, 75% were White, 5% were Black or African American, and 17% were Asian; 26% self-identified as Hispanic or Latino.

Compared with placebo, semaglutide tablets 7 mg and semaglutide tablets 14 mg once daily as monotherapy for 26 weeks resulted in statistically significant reductions in HbA1c. Specific results: Mean change in HbA1c from baseline was -0.3% for placebo, -1.2% for semaglutide tablets 7 mg (difference from placebo -0.9%), and -1.4% for semaglutide tablets 14 mg (difference from placebo -1.1%). The proportion of patients achieving HbA1c<7% was 31% for placebo, 69% for semaglutide tablets 7 mg, and 77% for semaglutide tablets 14 mg. For fasting plasma glucose (FPG), the mean change was -3 mg/dL for placebo, -28 mg/dL for semaglutide tablets 7 mg, and -33 mg/dL for semaglutide tablets 14 mg.

Mean baseline body weight was 88.6 kg, 89.0 kg, and 88.1 kg in the placebo, semaglutide tablets 7 mg, and semaglutide tablets 14 mg groups, respectively. The mean change from baseline to week 26 was -1.4 kg, -2.3 kg, and -3.7 kg, respectively. The difference in body weight compared with placebo was -0.9 kg for semaglutide tablets 7 mg and -2.3 kg for semaglutide tablets 14 mg.

FDA，2025.10