Retagliptin as add‐on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin: A multicentre, randomized, double‐blind, placebo‐controlled, phase 3 trial,Diabetes, Obesity and Metabolism

当前位置： X-MOL 学术 › Diabetes Obes. Metab. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Retagliptin as add‐on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin: A multicentre, randomized, double‐blind, placebo‐controlled, phase 3 trial
Diabetes, Obesity and Metabolism ( IF 5.8 ) Pub Date : 2024-04-11 , DOI: 10.1111/dom.15601
Lixin Guo ₁ , Fengsheng Tian ₂ , Li Liu ₃ , Mingwei Chen ₄ , Chengxia Jiang ₅ , Shuangqing Li ₆ , Cong Liu ₇ , Yawei Zhang ₈ , Jie Qin ₉ , Dongni Yu ₁ , Yicen Zong ₁₀ , Wei Dai ₁₀

Affiliation

Department of Endocrinology, Beijing Hospital; National Center of Gerontology, Institute of Geriatric Medicine Chinese Academy of Medical Science Beijing China
Department of Endocrinology Hebei Province Cangzhou Hospital of Integrated Traditional Chinese Medicine‐Western Medicine Cangzhou China
Department of Endocrinology The First Hospital of Hebei Medical University Shijiazhuang China
Department of Endocrinology The First Affiliated Hospital of Anhui Medical University Hefei China
Department of Endocrinology The Second People's Hospital of Yibin Yibin China
Department of General practice West China Hospital Chengdu China
Department of Endocrinology Shengjing Hospital of China Medical University Shenyang China
Department of Endocrinology Pingxiang People's Hospital Pingxiang China
Department of Endocrinology Shanxi Provincial People's Hospital Taiyuan China
Clinical Research and Development Jiangsu Hengrui Pharmaceuticals Co., Ltd Shanghai China

AimTo evaluate the efficacy and safety of retagliptin in Chinese patients with type 2 diabetes (T2D) inadequately controlled with metformin.Materials and MethodsThis multicentre, phase 3 trial consisted of a 16‐week, randomized, double‐blind, placebo‐controlled period, where patients with HbA1c levels between 7.5% and 11.0% were randomized to receive either once‐daily (QD) retagliptin 100 mg (n = 87) or placebo (n = 87), both as an add‐on to metformin. The primary endpoint was the change in HbA1c from baseline to week 16.ResultsAt week 16, the least squares mean change in HbA1c from baseline, compared with placebo, was −0.82% (95% CI, −1.05% to −0.58%) for the retagliptin 100 mg QD group (P < .0001) per treatment policy estimand. Significantly higher proportions of patients in the retagliptin 100 mg QD group achieved HbA1c levels of less than 6.5% (11.5%) and less than 7.0% (26.4%) compared with those receiving placebo (0% and 4.6%; P = .0016 and P < .0001, respectively) at week 16. Retagliptin 100 mg QD also lowered fasting plasma glucose and 2‐hour postprandial plasma glucose levels. The incidence of adverse events (AEs) during the treatment period was similar between the two groups. However, slightly higher proportions of increased lipase and increased amylase in the retagliptin 100 mg QD group were observed. No patients discontinued treatment permanently because of AEs, and no episodes of severe hypoglycaemia were reported.ConclusionsRetagliptin 100 mg QD as an add‐on therapy to metformin offers a new therapeutic option for treating Chinese patients with T2D inadequately controlled by metformin alone, and is generally well tolerated.

更新日期：2024-04-11

点击分享查看原文

点击收藏

阅读更多本刊最新论文

全部期刊列表>>