Efficacy and safety of oral semaglutide monotherapy compared with placebo in Chinese patients with type 2 diabetes who had insufficient glycemic control with diet and exercise alone: A subset analysis of the PIONEER-11 Trial
10.3760/cma.j.cn311282-20240313-00101
- VernacularTitle:司美格鲁肽片单药对比安慰剂治疗生活方式干预不佳中国2型糖尿病患者的有效性及安全性：PIONEER-11研究亚组分析
- Author:
Weiqing WANG
1
;
Yufeng LI
;
Xinhua YE
;
Bixuan DONG
;
Zewei SHEN
Author Information
1. 上海交通大学医学院附属瑞金医院内分泌代谢病科，上海 200025
- Keywords:
Diabetes mellitus, type 2;
Oral semaglutide;
Efficacy;
Safety;
China
- From:
Chinese Journal of Endocrinology and Metabolism
2024;40(11):932-940
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the efficacy and safety of oral semaglutide in Chinese patients with type 2 diabetes mellitus(T2DM) inadequately controlled by diet and exercise only.Methods:In the randomized, double-blind, multicenter, multinational PIONEER-11 trial, Chinese patients were prospectively randomly assigned to receive oral semaglutide 3, 7, or 14 mg, or placebo. The primary endpoint was the change from baseline in glycated hemoglobin(HbA 1C) at week 26. This is a pre-defined subset analysis to assess the efficacy and safety in Chinese patients. Results:Totally 390 Chinese T2DM patients were enrolled(mean age 51 years), with a T2DM duration of 1.8 years, HbA 1C of 7.9%, and BMI of 26.5 kg/m 2 at baseline. Overall, changes at week 26 from baseline in HbA 1C were -1.1%, -1.6%, -1.6%, and 0.0%, and in bodyweight were -0.7, -1.9, -2.6, and -0.7 kg in oral semaglutide(3, 7, or 14 mg) and placebo groups, respectively. Compared to the placebo group, estimated treatment differences(ETDs) in HbA 1C for the 3, 7, and 14 mg groups were -1.2%(95% CI -1.4, -0.9), -1.7%(95% CI -1.9, -1.4), and -1.6%(95% CI -1.9, -1.4)(all P<0.001), respectively, and in weight loss for the 7 mg and 14 mg groups were -1.2 kg(95% CI -2.1, -0.4; P=0.006) and -1.9 kg(95% CI -2.8, -1.0; P<0.001), respectively. The most frequent gastrointestinal adverse events were diarrhea(oral semaglutide: 3.1%-12.5% vs placebo: 2.0%) and nausea(3.1%-6.3% vs 2.0%), mostly mild in severity and transient. Conclusion:In Chinese patients with T2DM who had insufficient glycemic control with diet and exercise only, oral semaglutide showed better glycemic control at doses of 3, 7, and 14 mg and more weight loss at doses of 7 and 14 mg compared to placebo, with a safety profile consistent with that observed in the global trial population.
