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

在韩国2型糖尿病患者中,每周一次司美格鲁肽与每日一次西格列汀作为二甲双胍附加疗法的疗效和安全性比较

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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 (HbA(1c)) and body weight; additional endpoints assessed proportions of participants reaching targets of HbA(1c) < 7.0% and ≤ 6.5%, ≥ 5% weight loss, and a composite endpoint of HbA(1c) < 7.0% without severe/blood glucose-confirmed symptomatic hypoglycaemia and no weight gain. RESULTS: Korean participants (n = 110) showed a greater reduction in HbA(1c) 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). HbA(1c) 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.

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