Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as add-on to metformin in patients with type 2 diabetes in SUSTAIN China: A 30-week, double-blind, phase 3a, randomized trial.

Autor: Ji L; Peking University People's Hospital No. 11, Beijing, China., Dong X; Jinan Central Hospital, Affiliated to Shandong University No. 105, Jinan, China., Li Y; Shanghai Huashan Hospital, Affiliated to Fudan University No. 12, Shanghai, China., Li Y; Beijing Pinggu Hospital No. 59, Beijing, China., Lim S; Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea., Liu M; General Hospital of Tianjin Medical University No. 154, Tianjin, China., Ning Z; Novo Nordisk (China) Pharmaceuticals Co., Ltd, Beijing, China., Rasmussen S; Novo Nordisk A/S, Søborg, Denmark., Skjøth TV; Novo Nordisk A/S, Søborg, Denmark., Yuan G; The Affiliated Hospital of Jiangsu University No. 438, Zhenjiang, China., Eliaschewitz FG; CPClin/DASA Centro de Pesquisas Clínicas, São Paulo, Brazil.
Jazyk: angličtina
Zdroj: Diabetes, obesity & metabolism [Diabetes Obes Metab] 2021 Feb; Vol. 23 (2), pp. 404-414. Date of Electronic Publication: 2021 Jan 03.
DOI: 10.1111/dom.14232
Abstrakt: Aim: To evaluate the efficacy and safety of once-weekly subcutaneous semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, versus once-daily sitagliptin as add-on to metformin in patients with type 2 diabetes (T2D) in a multiregional clinical trial.
Materials and Methods: In the 30-week, randomized, double-blind, double-dummy, active comparator SUSTAIN China trial, 868 adults with T2D inadequately controlled on metformin (HbA1c 7.0%-10.5%) were randomized to receive once-weekly semaglutide 0.5 mg (n = 288), semaglutide 1.0 mg (n = 290) or once-daily sitagliptin 100 mg (n = 290). The primary and confirmatory secondary endpoints were change from baseline to week 30 in HbA 1c and body weight, respectively.
Results: The trial enrolled ~70% (605/868) of the patients in China, and the remaining patients from four other countries, including the Republic of Korea. Both doses of semaglutide were superior to sitagliptin in reducing HbA 1c and body weight after 30 weeks of treatment. The odds of achieving target HbA 1c  of less than 7.0% (53 mmol/mol), weight loss of 5% or higher, or 10% or higher, and the composite endpoint of HbA 1c  less than 7.0% (53 mmol/mol) without severe or blood glucose-confirmed symptomatic hypoglycaemia no weight gain, were all significantly higher with both semaglutide doses compared with sitagliptin. The safety profile for semaglutide was consistent with the known class effects of GLP-1 receptor agonists (RAs). Consistent efficacy and safety findings were seen in the Chinese subpopulation.
Conclusions: Once-weekly semaglutide was superior to sitagliptin in improving glycaemic control and reducing body weight in patients with T2D inadequately controlled on metformin. The safety and tolerability profiles were consistent with those of semaglutide and other GLP-1 RAs. Semaglutide is an effective once-weekly treatment option for the Chinese population.
(© 2020 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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