Efficacy and Safety of Once-Weekly Semaglutide Versus Once-Daily Sitagliptin as Metformin Add-on in a Korean Population with Type 2 Diabetes.

ABSTRACT

INTRODUCTION: Glucagon-like peptide-1 receptor agonists are well-established type 2 diabetes (T2D) treatments. As variations among populations and culture might influence treatment effects, this post hoc analysis evaluates the efficacy and safety of once-weekly (OW) semaglutide in a Korean population. METHODS: Korean adults with T2D inadequately controlled on metformin included in a 30-week, phase 3a, international, multicentre trial (NCT03061214) compared OW subcutaneous semaglutide (0.5 mg and 1.0 mg) with once-daily sitagliptin (100 mg). Key endpoints included change in glycated haemoglobin (HbA1c) and body weight; additional endpoints assessed proportions of participants reaching targets of HbA1c < 7.0% and ≤ 6.5%, ≥ 5% weight loss, and a composite endpoint of HbA1c < 7.0% without severe/blood glucose-confirmed symptomatic hypoglycaemia and no weight gain. RESULTS: Korean participants (n = 110) showed a greater reduction in HbA1c and body weight with semaglutide 0.5 mg (-1.6%, -2.7 kg) and 1.0 mg (-1.8%, -4.8 kg) versus sitagliptin (-0.9%, 0.5 kg). HbA1c targets of < 7.0% and ≤ 6.5% were achieved by more participants treated with semaglutide 0.5 mg (80.0% and 60.0%, respectively) and 1.0 mg (87.5% and 67.5%, respectively) versus sitagliptin (54.3% and 25.7%, respectively); ≥ 5% weight loss was observed in 42.9% and 65.0% of participants treated with semaglutide 0.5 mg and 1.0 mg versus 0.0% with sitagliptin. The composite endpoint was achieved by 71.4%, 77.5%, and 31.4% of the population in the semaglutide 0.5 mg, 1.0 mg, and sitagliptin group, respectively. No new safety concerns were observed. CONCLUSION: This analysis confirms efficacy and safety of OW semaglutide (0.5 and 1.0 mg) in a Korean population with T2D. CLINICAL TRIAL REGISTRATION NUMBER NCT03061214.