Intense simplified strategy for newly diagnosed type 2 diabetes in patients with severe hyperglycaemia: multicentre, open label, randomised trial

作者：Liehua Liu, Weijian Ke, Hai Li, Fangping Li, Guanjie Fan, Jian Kuang, Jianhua Ma, Xiuwei Zhang, Bing Ji, Shu Li, Yinghong Du, Yaoming Xue, Zhaohui Lyu, Leili Gao, Shen Qu, Yongquan Shi, Yan Li, Wanping Deng, Chaoyan Xu, Peiji Dai, Lijuan Xu, Juan Liu, Xuesi Wan, Guohong Wei, Shuang Yu, Shubin Hong, Pengyuan Zhang, Zhimin Huang, Xiaopei Cao, Zhihong Liao, Haipeng Xiao, Yiming Mu, Yehuda Handelsman, Yanbing Li · 发表于：BMJ · 年份：2024 · DOI：10.1136/bmj-2024-080122 · 被引用次数：18 · 研究领域：Diabetes Treatment and Management、Diabetes Management and Research、Diabetes, Cardiovascular Risks, and Lipoproteins

Abstract Objective To evaluate whether the intense simplified strategy, which comprises short term intensive insulin therapy (SIIT) followed by subsequent oral antihyperglycaemic regimens, could improve long term glycaemic outcomes in patients with newly diagnosed type 2 diabetes mellitus and severe hyperglycaemia. Design Multicentre, open label, randomised trial. Setting 15 hospitals in China between December 2017 and December 2020. Participants 412 patients with newly diagnosed type 2 diabetes and significant hyperglycaemia (HbA 1c ≥8.5%). Interventions All randomised participants initially received SIIT for 2-3 weeks, followed by linagliptin 5 mg/day, metformin 1000 mg/day, combination linagliptin plus metformin, or lifestyle modification alone (control) for 48 weeks. Main outcome measures The primary outcome was the percentage of participants achieving HbA 1c <7.0% at week 48 after SIIT. Secondary outcomes included glycaemic control, β cell function, and variations in insulin sensitivity. Results 412 participants were randomised. At baseline, the mean age was 46.8 (standard deviation 11.2) years, mean body mass index was 25.8 (2.9), and mean HbA 1c was 11.0% (1.9%). At week 48, 80% (78/97), 72% (63/88), and 73% (69/95) of patients in the linagliptin plus metformin, linagliptin, and metformin groups, respectively, achieved HbA 1c <7.0%, compared with 60% (56/93) in the control group (P=0.02 overall; P=0.003 for linagliptin plus metformin versus control; P=0.12 for li...