在2022年国际糖尿病联盟（IDF）大会上，首次以墙报形式展示了PIONEER 11和PIONEER 12研究的结果。这两项研究以中国人群为 主，为司美格鲁肽片（商品名：诺和忻）在中国的获批提供了重要支持。该药物的治疗剂量为7mg或14mg，适用于在饮食和运动控制不 足的基础上，作为单药或与二甲双胍和/或磺脲类药物联合治疗的成人2型糖尿病（T2DM）患者。 与欧美人群不同，中国的2型糖尿病患者通常在较年轻时就被诊断，且BMI较低，这可能影响药物的治疗效果，因此中国研究是必要的。 在中国人群中，司美格鲁肽片的疗效和安全性数据相对较少，PIONEER 11和12研究则为该领域提供了重要的临床数据。 PIONEER系列的全球3期临床试验比较了司美格鲁肽片与活性对照药物及安慰剂在降糖效果和安全性上的差异，以及体重的减轻，结果 显示，司美格鲁肽片能够持续改善血糖控制以及减重，且效果优于活性对照药物和安慰剂。 整理 | GLP1减重宝典内容团队 ▍PIONEER 11 单药治疗 PIONEER 11研究在饮食和运动控制不佳的中国2型糖尿病患者中，评估了司美格鲁肽片单药治疗的有效性与安全性。研究结果显示， 中 国 人群的临 ...

Core Viewpoint - The PIONEER 11 and PIONEER 12 studies provide significant clinical data supporting the approval of semaglutide tablets (brand name: Ozempic) for type 2 diabetes (T2DM) treatment in the Chinese population, demonstrating its efficacy and safety compared to active controls and placebo [2][3][14]. Group 1: PIONEER 11 Study - The PIONEER 11 study evaluated the efficacy and safety of semaglutide as monotherapy in Chinese T2DM patients with inadequate diet and exercise control, highlighting differences in clinical profiles compared to Western populations [4][9]. - This study was a 26-week, randomized, double-blind, placebo-controlled, multi-center Phase 3 trial involving 521 T2DM patients, with approximately 75% being Chinese. The primary endpoint was the change in HbA1c levels from baseline at week 26, and the confirmatory secondary endpoint was weight change [5]. - Results showed that all doses of semaglutide (3mg, 7mg, 14mg) significantly reduced HbA1c compared to placebo, with the 14mg group achieving a reduction of 1.6%. Additionally, the 7mg and 14mg groups experienced significant weight loss, with the 14mg group losing 3.0kg overall and 2.6kg in the Chinese subgroup [5][11]. Group 2: Safety and Tolerability - The study indicated that gastrointestinal adverse events were the most common, mostly mild and transient, with no reports of severe hypoglycemia and a low incidence of serious adverse events across all groups [7][13]. Group 3: PIONEER 12 Study - The PIONEER 12 study assessed the combined effect of semaglutide with sitagliptin in T2DM patients on stable doses of metformin, revealing potential differences in clinical profiles and drug responses in the Chinese population compared to Western groups [9][10]. - This was also a 26-week, randomized, double-blind, active-controlled, multi-center Phase 3 trial involving 1441 patients, with around 75% being Chinese. The primary and secondary endpoints were consistent with PIONEER 11, focusing on HbA1c and safety [10]. - Results indicated that all doses of semaglutide significantly outperformed sitagliptin in reducing HbA1c, with the 14mg group achieving a reduction of 1.6%. Weight loss was also significantly greater in the semaglutide groups compared to sitagliptin, with the 14mg group losing 3.8kg overall and 3.4kg in the Chinese subgroup [11][14]. Group 4: Conclusion - The 14mg dose of oral semaglutide demonstrated significant weight loss and glycemic control in the Chinese population, suggesting it is well-suited for use in this demographic despite lower baseline weights, indicating a promising application outlook [14].