Efficacy and safety of oral semaglutide versus sitagliptin in patients with type 2 diabetes mellitus insufficiently uncontrolled on metformin: Chinese subgroup analysis of PIONEER 12 study
10.3760/cma.j.cn311282-20240425-00167
- VernacularTitle:二甲双胍控制不佳的中国2型糖尿病患者司美格鲁肽片对比西格列汀的有效性与安全性：PIONEER 12研究中国人群亚组分析
- Author:
Linong JI
1
;
Ji HU
;
Xiaozhen JIANG
;
Jun LIU
;
Wenyan LIU
;
Qi MENG
;
Zewei SHEN
Author Information
1. 北京大学人民医院内分泌代谢科 100044
- Keywords:
Diabetes mellitus, type 2;
Oral semaglutide;
Sitagliptin;
Metformin;
Chinese patients
- From:
Chinese Journal of Endocrinology and Metabolism
2024;40(10):835-843
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of oral semaglutide versus sitagliptin in Chinese patients with type 2 diabetes mellitus(T2DM) inadequately controlled with metformin. Methods:The PIONEER 12 study was a phase Ⅲ clinical trial. Chinese patients were prospectively randomized to oral semaglutide(3mg, 7 mg, and 14 mg) or sitagliptin 100 mg. The primary endpoint was the change in HbA 1C from baseline to week 26, and the confirmatory secondary efficacy endpoint was the change in body weight from baseline to week 26. Results:Totally 1 084 Chinese participants(mean age 53 years, male 62.2%, mean duration of diabetes 5.5 years, HbA 1C 8.2%, and body weight 74.3 kg) were enrolled. The changes in HbA 1C at week 26 from baseline were -0.9%, -1.4%, and -1.6% for oral semaglutide 3 mg, 7 mg, and 14 mg, respectively, and -0.7% for sitagliptin. Compared to sitagliptin, oral semaglutide 3 mg, 7 mg, and 14 mg significantly reduced HbA 1C [estimated treatment difference(ETD), -0.2%(95% CI -0.4--0.0), -0.8%(95% CI -0.9--0.6), and -0.9%(95% CI -1.1--0.8), respectively; 3 mg, P=0.011, 7 mg and 14mg, P<0.001]. The estimated mean changes in body weight at week 26 from baseline were -1.1 kg, -2.5 kg, and -3.4 kg for oral semaglutide 3 mg, 7 mg, and 14 mg, respectively, and -0.4 kg for sitagliptin 100 mg. Compared with sitagliptin, oral semaglutide 3 mg, 7 mg, and 14 mg significantly reduced body weight [ETD, -0.8 kg(95% CI -1.3--0.2), -2.1 kg(95% CI -2.6--1.6), and -3.0 kg(95% CI -3.5--2.5), respectively; 3 mg, P=0.004, 7 mg and 14 mg, P<0.001]. The overall incidence of adverse events was similar across all treatment groups. The most common adverse events were gastrointestinal disorders, mostly mild or moderate in severity and transient in duration. Conclusions:Oral semaglutide resulted in significantly greater reduction in HbA 1C and body weight versus sitagliptin at week 26, with a favorable safety and tolerability profile in Chinese T2DM patients inadequately controlled with metformin.
