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Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial.
Sci China Life Sci. 2017 Mar; 60(3):225-238.SC

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.

Authors+Show Affiliations

Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University; Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, 510630, China.Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, 100853, China. muyiming@301hospital.com.cn.Department of Endocrinology and Metabolism, Shandong Provincial Hospital affiliated to Shandong University, Jinan, 250021, China.Department of Endocrinology, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, China.Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, 710032, China.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, 410011, China.Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University; Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, 510630, China.Merck Sharp & Dohme China, Shanghai, 200020, China.Merck & Co, Inc., Kenilworth, NJ, 07033, USA.Merck Sharp & Dohme China, Shanghai, 200020, China.Department of Endocrinology, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, China.Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University; Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, 510630, China.Department of Endocrinology, West China Hospital, Sichuan University, Chengdu, 610041, China.Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, 100853, China.Department of Endocrinology, Peking University People's Hospital, Beijing, 100044, China.Department of Endocrinology, China-Japan Friendship Hospital, Beijing, 100029, China.Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Clinical Center for Diabetes, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China. wpjia@sjtu.edu.cn.Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University; Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, 510630, China. wjianp@mail.sysu.edu.cn.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28271251

Citation

Xu, Wen, et al. "Efficacy and Safety of Metformin and Sitagliptin Based Triple Antihyperglycemic Therapy (STRATEGY): a Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial." Science China. Life Sciences, vol. 60, no. 3, 2017, pp. 225-238.
Xu W, Mu Y, Zhao J, et al. Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial. Sci China Life Sci. 2017;60(3):225-238.
Xu, W., Mu, Y., Zhao, J., Zhu, D., Ji, Q., Zhou, Z., Yao, B., Mao, A., Engel, S. S., Zhao, B., Bi, Y., Zeng, L., Ran, X., Lu, J., Ji, L., Yang, W., Jia, W., & Weng, J. (2017). Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial. Science China. Life Sciences, 60(3), 225-238. https://doi.org/10.1007/s11427-016-0409-7
Xu W, et al. Efficacy and Safety of Metformin and Sitagliptin Based Triple Antihyperglycemic Therapy (STRATEGY): a Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial. Sci China Life Sci. 2017;60(3):225-238. PubMed PMID: 28271251.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial. AU - Xu,Wen, AU - Mu,Yiming, AU - Zhao,Jiajun, AU - Zhu,Dalong, AU - Ji,Qiuhe, AU - Zhou,Zhiguang, AU - Yao,Bin, AU - Mao,Anhua, AU - Engel,Samuel S, AU - Zhao,Bin, AU - Bi,Yan, AU - Zeng,Longyi, AU - Ran,Xingwu, AU - Lu,Juming, AU - Ji,Linong, AU - Yang,Wenying, AU - Jia,Weiping, AU - Weng,Jianping, Y1 - 2017/02/07/ PY - 2016/12/27/received PY - 2017/01/06/accepted PY - 2017/3/9/pubmed PY - 2017/5/17/medline PY - 2017/3/9/entrez KW - DPP-4 inhibitor KW - acarbose KW - gliclazide KW - glimepiride KW - metformin KW - oral antihyperglycemic agent KW - repaglinide KW - type 2 diabetes SP - 225 EP - 238 JF - Science China. Life sciences JO - Sci China Life Sci VL - 60 IS - 3 N2 - 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. SN - 1869-1889 UR - https://www.unboundmedicine.com/medline/citation/28271251/Efficacy_and_safety_of_metformin_and_sitagliptin_based_triple_antihyperglycemic_therapy__STRATEGY_:_a_multicenter_randomized_controlled_non_inferiority_clinical_trial_ L2 - https://dx.doi.org/10.1007/s11427-016-0409-7 DB - PRIME DP - Unbound Medicine ER -