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

• Published in: BMJ (Online) 2024-10, Vol.387, p.e080122
• Main Authors: Liu, Liehua, Ke, Weijian, Li, Hai, Li, Fangping, Fan, Guanjie, Kuang, Jian, Ma, Jianhua, Zhang, Xiuwei, Ji, Bing, Li, Shu, Du, Yinghong, Xue, Yaoming, Lyu, Zhaohui, Gao, Leili, Qu, Shen, Shi, Yongquan, Yan, Li, Deng, Wanping, Xu, Chaoyan, Dai, Peiji, Xu, Lijuan, Liu, Juan, Wan, Xuesi, Wei, Guohong, Yu, Shuang, Hong, Shubin, Zhang, Pengyuan, Huang, Zhimin, Cao, Xiaopei, Liao, Zhihong, Xiao, Haipeng, Mu, Yiming, Handelsman, Yehuda, Li, Yanbing
• Format: Article
• Language: English
• Subjects: Adult; Beta cells; Blood Glucose - analysis; Blood Glucose - metabolism; Body mass index; China; Creatinine; Decision making; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - drug therapy; Diabetic neuropathy; Drug Therapy, Combination; Exercise; Female; Glucose; Glycated Hemoglobin - analysis; Hospitals; Humans; Hyperglycemia; Hyperglycemia - drug therapy; Hypoglycemic Agents - therapeutic use; Insulin; Insulin - administration & dosage; Insulin - therapeutic use; Lifestyles; Linagliptin - therapeutic use; Male; Medical research; Metformin; Metformin - therapeutic use; Middle Aged; Patients; Physical fitness; Remission (Medicine); Treatment Outcome
• ISSN: 1756-1833; 0959-8138; 1756-1833
• DOI: 10.1136/bmj-2024-080122

AbstractObjectiveTo 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.DesignMulticentre, open label, randomised trial.Setting15 hospitals in China between December 2017 and December 2020.Participants412 patients with newly diagnosed type 2 diabetes and significant hyperglycaemia (HbA1c ≥8.5%).InterventionsAll 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 measuresThe primary outcome was the percentage of participants achieving HbA1c