Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter,randomized, controlled,non-inferiority clinical trial |
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| Authors: | Wen Xu Yiming Mu Jiajun Zhao Dalong Zhu Qiuhe Ji Zhiguang Zhou Bin Yao Anhua Mao Samuel S Engel Bin Zhao Yan Bi Longyi Zeng Xingwu Ran Juming Lu Linong Ji Wenying Yang Weiping Jia Jianping Weng |
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| Institution: | 1.Department of Endocrinology and Metabolism,the Third Affiliated Hospital of Sun Yat-Sen University; Guangdong Provincial Key Laboratory of Diabetology,Guangzhou,China;2.Department of Endocrinology,Chinese People’s Liberation Army General Hospital,Beijing,China;3.Department of Endocrinology and Metabolism,Shandong Provincial Hospital affiliated to Shandong University,Jinan,China;4.Department of Endocrinology, Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School,Nanjing,China;5.Department of Endocrinology, Xijing Hospital,Fourth Military Medical University,Xi’an,China;6.Institute of Metabolism and Endocrinology, The Second Xiangya Hospital and the Diabetes Center, Key Laboratory of Diabetes Immunology,Ministry of Education Central South University, National Clinical Research Center for Metabolic Diseases,Changsha,China;7.Merck Sharp & Dohme China,Shanghai,China;8.Merck & Co, Inc.,Kenilworth,USA;9.Department of Endocrinology, West China Hospital,Sichuan University,Chengdu,China;10.Department of Endocrinology,Peking University People’s Hospital,Beijing,China;11.Department of Endocrinology,China-Japan Friendship Hospital,Beijing,China;12.Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Clinical Center for Diabetes,Shanghai Jiao Tong University Affiliated Sixth People’s Hospital,Shanghai,China |
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| Abstract: | Despite the current guideline’s recommendation of a timely stepwise intensification therapy, the “clinical inertia”, termed as the delayed treatment intensification, commonly exists in the real world, which may be partly due to the relatively little substantial evidence and no clear consensus regarding the efficacy and safety of triple oral agents in patients inadequately controlled with dual therapy. In this clinical trial performed in 237 centers in China, 5,535 type 2 diabetic patients inadequately controlled by previous therapies were treated with a stable metformin/sitagliptin dual therapy for 20 weeks. The patients who did not reach the glycated hemoglobin A1c (HbA1c) goal were then further randomized into glimepiride, gliclazide, repaglinide, or acarbose group for an additional 24-week triple therapy. A mean HbA1c reduction of 0.85% was observed when sitagliptin was added to the patients inadequately controlled with metformin in 16 weeks. Further HbA1c reductions in the 24-week triple therapy stage were 0.65% in glimepiride group, 0.70% in gliclazide group, 0.61% in repaglinide group, and 0.45% in acarbose group. The non-inferiority criterion for primary hypotheses was met for gliclazide and repaglinide, but not for acarbose, compared with glimepiride, when added to metformin/sitagliptin dual therapy. The incidences of adverse events (AEs) were 29.2% in the dual therapy stage and 30.3% in the triple therapy stage. Metformin/sitagliptin as baseline therapy, with the addition of a third oral antihyperglycemic agent, including glimepiride, gliclazide, repaglinide, or acarbose, was effective, safe and well-tolerated for achieving an HbA1c <7.0% goal in type 2 diabetic patients inadequately controlled with previous therapies. The timely augmentation of up to three oral antihyperglycemic agents is valid and of important clinical benefit to prevent patients from exposure to unnecessarily prolonged hyperglycemia. |
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