Comparison Between Pioglitazone/Metformin Combination Therapy and Sitagliptin/Metformin Combination Therapy on the Efficacy in Chinese Type 2 Diabetic Adults Insufficiently Controlled with Metformin: Study Protocol of an Open-Label, Multicenter, Non-Inferiority Parallel-Group Randomized Controlled Trial

References

• Xu Y , Wang L , He J , et al. Prevalence and control of diabetes in Chinese adults. JAMA . 2013;310(9):948–959. doi:10.1001/jama.2013.168118 24002281
   PubMed Web of Science ®Google Scholar
• Kodama K , Tojjar D , Yamada S , et al. Ethnic differences in the relationship between insulin sensitivity and insulin response: a systematic review and meta-analysis. Diabetes Care . 2013;36(6):1789–1796. doi:10.2337/dc12-1235 23704681
   PubMed Web of Science ®Google Scholar
• Ahuja V , Kadowaki T , Evans RW , et al. Comparison of HOMA-IR, HOMA-β% and disposition index between US white men and Japanese men in Japan: the ERA JUMP study. Diabetologia . 2015;58(2):265–271. doi:10.1007/s00125-014-3414-6 25316435
   PubMed Web of Science ®Google Scholar
• Wang T , Lu J , Shi L , et al. Association of insulin resistance and β-cell dysfunction with incident diabetes among adults in China: a nationwide, population-based, prospective cohort study. Lancet Diabetes Endocrinol . 2020;8(2):115–124. doi:10.1016/S2213-8587(19)30425-5 31879247
   PubMed Web of Science ®Google Scholar
• Garber AJ , Abrahamson MJ , Barzilay JI , et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm - 2018 Executive Summary. Endocr Pract . 2018;24(1):91–120.29368965
   PubMed Web of Science ®Google Scholar
• Jia W , Weng J , Zhu D , et al. Standards of medical care for type 2 diabetes in China 2019. Diabetes Metab Res Rev . 2019;35(6):e3158. doi:10.1002/dmrr.3158 30908791
   PubMed Web of Science ®Google Scholar
• UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood‐glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet . 1998;352:854‐865.
   Web of Science ®Google Scholar
• Hong J , Zhang Y , Lai S , et al. Effects of metformin versus glipizide on cardiovascular outcomes in patients with type 2 diabetes and coronary artery disease. Diabetes Care . 2013;36(5):1304–1311. doi:10.2337/dc12-0719 23230096
   PubMed Web of Science ®Google Scholar
• Lu ZH , Pan CY , Gao Y , et al. A randomized, double blind, placebo-controlled, parallel and multicenter study to evaluate the safety and efficacy of pioglitazone with sulphonylurea in type 2 diabetic patients. Zhonghua Nei Ke Za Zhi . 2011;50(10):826–830.22321321
   PubMedGoogle Scholar
• Pan C , Gao Y , Gao X , et al. The efficacy and safety of pioglitazone hydrochloride in combination with sulphonylureas and metfomin in the treatment of type 2 diabetes mellitus a 12-week randomized multi-centres placebo-controlled parallel study. Zhonghua Nei Ke Za Zhi . 2002;41(6):388–392.12137601
   PubMedGoogle Scholar
• Dormandy JA , Charbonnel B , Eckland DJ , et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet . 2005;366:1279–1289. doi:10.1016/S0140-6736(05)67528-9 16214598
   PubMed Web of Science ®Google Scholar
• Kernan WN , Viscoli CM , Furie KL , et al. Pioglitazone after ischemic stroke or transient ischemic attack. N Engl J Med . 2016;374(14):1321–1331. doi:10.1056/NEJMoa1506930 26886418
   PubMed Web of Science ®Google Scholar
• Kodama N , Tahara N , Tahara A , et al. Effects of pioglitazone on visceral fat metabolic activity in impaired glucose tolerance or type 2 diabetes mellitus. J Clin Endocrinol Metab . 2013;98(11):4438–4445. doi:10.1210/jc.2013-2920 24030946
   PubMed Web of Science ®Google Scholar
• Bi Y , Zhang B , Xu W , et al. Effects of exenatide, insulin, and pioglitazone on liver fat content and body fat distributions in drug-naive subjects with type 2 diabetes. Acta Diabetol . 2014;51(5):865–873. doi:10.1007/s00592-014-0638-3 25118999
   PubMed Web of Science ®Google Scholar
• Ji L , Han P , Wang X , et al. Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus. J Diabetes Investig . 2016;7(5):727–736. doi:10.1111/jdi.12511
   Web of Science ®Google Scholar
• Mohan V , Yang W , Son HY , et al. Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. Diabetes Res Clin Pract . 2009;83(1):106–116. doi:10.1016/j.diabres.2008.10.009 19097665
   PubMed Web of Science ®Google Scholar
• Yang W , Guan Y , Shentu Y , et al. The addition of sitagliptin to ongoing metformin therapy significantly improves glycemic control in Chinese patients with type 2 diabetes. J Diabetes . 2012;4(3):227–237. doi:10.1111/j.1753-0407.2012.00213.x 22672586
   PubMed Web of Science ®Google Scholar
• Green JB , Bethel MA , Armstrong PW , et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med . 2015;373(3):232–242. doi:10.1056/NEJMoa1501352 26052984
   PubMed Web of Science ®Google Scholar
• Yan J , Yao B , Kuang H , et al. Liraglutide, sitagliptin, and insulin glargine added to metformin: the effect on body weight and intrahepatic lipid in patients with type 2 diabetes mellitus and nonalcoholic fatty liver disease. Hepatology . 2019;69(6):2414–2426. doi:10.1002/hep.30320 30341767
   PubMed Web of Science ®Google Scholar
• Del Prato S , Chilton R . Practical strategies for improving outcomes in T2DM: the potential role of pioglitazone and DPP4 inhibitors. Diabetes Obes Metab . 2018;20(4):786–799. doi:10.1111/dom.13169 29171700
   PubMed Web of Science ®Google Scholar
• Russell-Jones D , Cuddihy RM , Hanefeld M , et al. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care . 2012;35(2):252–258. doi:10.2337/dc11-1107 22210563
   PubMed Web of Science ®Google Scholar
• Bergenstal RM , Wysham C , Macconell L , et al. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet . 2010;376(9739):431–439. doi:10.1016/S0140-6736(10)60590-9 20580422
   PubMed Web of Science ®Google Scholar
• Hsia SH , Navar MD , Duran P , et al. Sitagliptin compared with thiazolidinediones as a third-line oral antihyperglycemic agent in type 2 diabetes mellitus. Endocr Pract . 2011;17(5):691–698. doi:10.4158/EP10405.OR 21550951
   PubMed Web of Science ®Google Scholar
• Liu SC , Chien KL , Wang CH , et al. Efficacy and safety of adding pioglitazone or sitagliptin to patients with type 2 diabetes insufficiently controlled with metformin and a sulfonylurea. Endocr Pract . 2013;19(6):980–988. doi:10.4158/EP13148.OR 23807528
   PubMed Web of Science ®Google Scholar
• Jameshorani M , Sayari S , Kiahashemi N , et al. Comparative study on adding pioglitazone or sitagliptin to patients with type 2 diabetes mellitus insufficiently controlled with metformin. Open Access Maced J Med Sci . 2017;5(7):955–962. doi:10.3889/oamjms.2017.193 29362626
   PubMedGoogle Scholar
• Chawla S , Kaushik N , Singh NP , et al. Effect of addition of either sitagliptin or pioglitazone in patients with uncontrolled type 2 diabetes mellitus on metformin: a randomized controlled trial. J Pharmacol Pharmacother . 2013;4(1):27–32. doi:10.4103/0976-500X.107656 23662021
   PubMedGoogle Scholar
• Bae J , Kim G , Lee YH , et al. Differential effects of thiazolidinediones and dipeptidyl peptidase-4 inhibitors on insulin resistance and β-cell function in type 2 diabetes mellitus: a propensity score-matched analysis. Diabetes Ther . 2019;10(1):149–158. doi:10.1007/s13300-018-0541-y 30506494
   PubMed Web of Science ®Google Scholar
• Lu J , Zang J , Li H . Impact of three oral antidiabetic drugs on markers of β-cell function in patients with type 2 diabetes: a meta-analysis. PLoS One . 2013;8(10):e76713. doi:10.1371/journal.pone.0076713 24204660
   PubMed Web of Science ®Google Scholar
• Ohki T , Isogawa A , Iwamoto M , et al. The effectiveness of liraglutide in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus compared to sitagliptin and pioglitazone. Sci World J . 2012;2012:496453. doi:10.1100/2012/496453
   Web of Science ®Google Scholar
• Han M , Qin P , Li Q , et al. Chinese visceral adiposity index: a reliable indicator of visceral fat function associated with risk of type 2 diabetes. Diabetes Metab Res Rev . 2020;e3370.32562335
   PubMed Web of Science ®Google Scholar
• Wang H , Zhai F . Options for preventing obesity in China. Obes Rev . 2013;14:134–140. doi:10.1111/obr.12106 24102781
   PubMed Web of Science ®Google Scholar
• Yabiku K , Mutoh A , Miyagi K , et al. Effects of oral antidiabetic drugs on changes in the liver-to-spleen ratio on computed tomography and inflammatory biomarkers in patients with type 2 diabetes and nonalcoholic fatty liver disease. Clin Ther . 2017;39(3):558–566. doi:10.1016/j.clinthera.2017.01.015 28185715
   PubMed Web of Science ®Google Scholar
• Chan AW , Tetzlaff JM , Gøtzsche PC , et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ . 2013;346:e7586. doi:10.1136/bmj.e7586 23303884
   PubMed Web of Science ®Google Scholar
• World Health Organization. Definition, Diagnosis and Classification of Diabetes Mellitus and Its Complications; Part 1: Diagnosis and Classification of Diabetes Mellitus . Geneva: Department of Noncommunicable Disease Surveillance; 1999.
   Google Scholar
• National Medical Products Administration. Guidelines for clinical trials of drugs and biological products for the treatment of diabetes. National Food and Drug Administration Note [2012] No. 122 . 2012.
   Google Scholar
• Chow SC , Shao J , Wang H , et al. Sample Size Calculations in Clinical Research . Third ed. Taylor & Francis Group, Boca Raton, FL 33487-2742; 2018:43(3.6)
   Google Scholar
• European Medicines Agency. ICH E9: Statistical Principles for Clinical Trials. 1998.
   Google Scholar
• Lee RC , Wang ZM , Heymsfield SB . Skeletal muscle mass and aging: regional and whole body measurement methods. Can J Appl Physiol . 2001;26:102–122. doi:10.1139/h01-008 11173672
   PubMedGoogle Scholar
• Chen LK , Liu LK , Woo J , et al. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc . 2014;15(2):95–101. doi:10.1016/j.jamda.2013.11.025 24461239
   PubMed Web of Science ®Google Scholar
• Cui J , Philo L , Nguyen P , et al. Sitagliptin vs. placebo for non-alcoholic fatty liver disease: a randomized controlled trial. J Hepatol . 2016;65(2):369–376. doi:10.1016/j.jhep.2016.04.021 27151177
   PubMed Web of Science ®Google Scholar
• Teranishi T , Ohara T , Maeda K , et al. Effects of pioglitazone and metformin on intracellular lipid content in liver and skeletal muscle of individuals with type 2 diabetes mellitus. Metabolism . 2007;56(10):1418–1424. doi:10.1016/j.metabol.2007.06.005 17884455
   PubMed Web of Science ®Google Scholar
• Tushuizen ME , Bunck MC , Pouwels PJ , et al. Pancreatic fat content and beta-cell function in men with and without type 2 diabetes. Diabetes Care . 2007;30(11):2916–2921. doi:10.2337/dc07-0326 17666465
   PubMed Web of Science ®Google Scholar