{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T18:30:14Z","timestamp":1788201014640,"version":"build-2803163510"},"reference-count":66,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T00:00:00Z","timestamp":1787961600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T00:00:00Z","timestamp":1787961600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"abstract":"<jats:sec>\n                    <jats:title>Introduction:<\/jats:title>\n                    <jats:p>Randomized controlled trials are the gold standard for evaluating interventions but are resource-intensive and impose considerable burden on participants. Historical control designs, which incorporate data from previous trials into new analyses, could reduce sample size requirements, but their practical application is limited. This study explored the feasibility of constructing a historical control using the Bayesian meta-analytic predictive approach based on data from a systematic review of metformin in type 2 diabetes mellitus.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We extracted baseline and end point glycated hemoglobin values and participant characteristics from 25 randomized trials (36 comparisons). Using the RBesT package in the R software, meta-analytic predictive priors were constructed, and their contribution to new data was quantified using the effective sample size metric. Between-trial heterogeneity (\u03c4) was initially set to the default conservative value (0.5) and subsequently estimated and replaced in the analysis using the output from the metafor package based on the reported study-level variances. Additional stratified analyses based on follow-up duration and publication year were conducted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Initial models yielded low effective sample size values (1\u20134), indicating minimal information borrowing from historical data. The presence of a high level of heterogeneity (\u03c4\u2009=\u20090.55\u20130.85) appeared to limit the priors\u2019 influence. Further investigation into a stricter data set showed that four outlier studies reduced the estimated \u03c4 from the data to 0.0935, which increased effective sample size from 18 (conservative model) to 52 (data-derived model), while estimated treatment effects remained stable (\u22121.34% to \u22121.36% glycated hemoglobin).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion:<\/jats:title>\n                    <jats:p>Between-trial heterogeneity (\u03c4) estimation critically influences the informativeness of meta-analytic predictive\u2013based historical control analysis. Despite having 25 trials with the same condition, the effective sample size was very low. Data-driven \u03c4 estimation substantially increased effective sample size without altering the treatment effect estimates and could represent a valid alternative to historical controls in clinical trial design compared with default conservative choices.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17407745261467982","type":"journal-article","created":{"date-parts":[[2026,8,30]],"date-time":"2026-08-30T02:07:31Z","timestamp":1788055651000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["A practical application for the efficient use of historical data in randomized controlled design using systematic review data"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-9182-4575","authenticated-orcid":false,"given":"Tim J.","family":"Schouten","sequence":"first","affiliation":[{"name":"Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Gabrio","sequence":"additional","affiliation":[{"name":"Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jochen W. L.","family":"Cals","sequence":"additional","affiliation":[{"name":"Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Spigt","sequence":"additional","affiliation":[{"name":"Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,8,29]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2020.06.015"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-019-1476-5"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.44412"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.01.014"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1525\/jer.2009.4.3.89"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e8668"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780030405"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1983.10477953"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.2307\/2530304"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/0021-9681(76)90044-8"},{"key":"e_1_3_3_12_2","first-page":"1","volume-title":"Wiley encyclopedia of clinical trials","author":"Thomas N","year":"2007","unstructured":"Thomas N. Historical control. In: D\u2019Agostino RB, Sullivan LM, Massaro JM (eds) Wiley encyclopedia of clinical trials. Wiley, 2007, pp.1\u20133."},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62297-7"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.2307\/2532862"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.2307\/2532254"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1177\/1740774520944855"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13023-020-1332-x"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb1609216"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1038\/s43856-022-00155-y"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12561-022-09342-w"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2024.105724"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1177\/1740774509356002"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1111\/biom.12242"},{"key":"e_1_3_3_24_2","first-page":"1634","volume-title":"Encyclopedia of environmetrics","author":"Gelman A","year":"2002","unstructured":"Gelman A. Prior distribution. In: El-Shaarawi AH, Piegorsch WW (eds) Encyclopedia of environmetrics. John Wiley & Sons, Ltd, 2002, pp.1634\u20131637."},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.18637\/jss.v100.i19"},{"key":"e_1_3_3_26_2","article-title":"Metformin monotherapy for adults with type 2 diabetes mellitus","volume":"6","author":"Gnesin F","year":"2020","unstructured":"Gnesin F, Thuesen ACB, K\u00e4hler LKA, et al. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev 2020; 6: CD012906.","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_3_3_27_2","unstructured":"Li Y. RBest for a normal endpoint https:\/\/opensource.nibr.com\/RBesT\/articles\/introduction_normal.html (2025 accessed 18 March)."},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1995.10476592"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.1111\/biom.13252"},{"key":"e_1_3_3_30_2","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2011-301668"},{"key":"e_1_3_3_31_2","doi-asserted-by":"crossref","unstructured":"Mudaliar S. The evolution of diabetes treatment through the ages: from starvation diets to insulin incretins SGLT2-inhibitors and beyond. J Indian Inst Sci. Epub ahead of print 21 February 2023. https:\/\/doi.org\/10.1007\/s41745-023-00357-w","DOI":"10.1007\/s41745-023-00357-w"},{"key":"e_1_3_3_32_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa2032271"},{"key":"e_1_3_3_33_2","doi-asserted-by":"publisher","DOI":"10.18637\/jss.v036.i03"},{"key":"e_1_3_3_34_2","unstructured":"Team RC. R: a language and environment for statistical computing https:\/\/www.R-project.org\/ (2024 accessed 15 August 2025)."},{"key":"e_1_3_3_35_2","unstructured":"Team P. RStudio: integrated development environment for R 2025 http:\/\/www.posit.co\/"},{"key":"e_1_3_3_36_2","doi-asserted-by":"publisher","DOI":"10.1214\/ss\/1177011136"},{"key":"e_1_3_3_37_2","unstructured":"Burkner P-C Vehtari A. Convergence and efficiency diagnostics for Markov Chains 2026 https:\/\/mc-stan.org\/rstan\/reference\/Rhat.html"},{"key":"e_1_3_3_38_2","doi-asserted-by":"crossref","unstructured":"Bilezikian JP Josse RG Eastell R et al. Rosiglitazone decreases bone mineral density and increases bone turnover in postmenopausal women with type 2 diabetes mellitus. J Clin Endocrinol Metab 2013; 98(4): 1519\u20131528. https:\/\/doi.org\/10.1210\/jc.2012-4018","DOI":"10.1210\/jc.2012-4018"},{"key":"e_1_3_3_39_2","doi-asserted-by":"crossref","unstructured":"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: 1304\u20131311. https:\/\/doi.org\/10.2337\/dc12-0719","DOI":"10.2337\/dc13-2003"},{"key":"e_1_3_3_40_2","doi-asserted-by":"crossref","unstructured":"Derosa G Mugellini A Ciccarelli L et al. Comparison of glycaemic control and cardiovascular risk profile in patients with type 2 diabetes during treatment with either repaglinide or metformin. Diabetes Res Clin Pract 2003; 60: 161\u2013169. https:\/\/doi.org\/10.1016\/s0168-8227(03)00057-3","DOI":"10.1016\/S0168-8227(03)00057-3"},{"key":"e_1_3_3_41_2","doi-asserted-by":"crossref","unstructured":"Derosa G Maffioli P Salvadeo SA et al. Direct comparison among oral hypoglycemic agents and their association with insulin resistance evaluated by euglycemic hyperinsulinemic clamp: the 60\u2019s study. Metabolism 2009; 58(8): 1059\u20131066. https:\/\/doi.org\/10.1016\/j.metabol.2009.03.007","DOI":"10.1016\/j.metabol.2009.03.007"},{"key":"e_1_3_3_42_2","doi-asserted-by":"crossref","unstructured":"Erem C Ozbas HM Nuhoglu I et al. Comparison of effects of gliclazide metformin and pioglitazone monotherapies on glycemic control and cardiovascular risk factors in patients with newly diagnosed uncontrolled type 2 diabetes mellitus. Exp Clin Endocrinol Diabetes 2014; 122(5): 295\u2013302. https:\/\/doi.org\/10.1055\/s-0034-1370989","DOI":"10.1055\/s-0034-1370989"},{"key":"e_1_3_3_43_2","doi-asserted-by":"crossref","unstructured":"Kiyici S Ersoy C Kaderli A et al. Effect of rosiglitazone metformin and medical nutrition treatment on arterial stiffness serum MMP-9 and MCP-1 levels in drug naive type 2 diabetic patients. Diabetes Res Clin Pract 2009; 86(1): 44\u201350. https:\/\/doi.org\/10.1016\/j.diabres.2009.07.004","DOI":"10.1016\/j.diabres.2009.07.004"},{"key":"e_1_3_3_44_2","doi-asserted-by":"crossref","unstructured":"Rahman IU Malik SA Bashir M et al. Monotherapy with metformin or glimepiride and changes in serum sialic acid in type 2 diabetes mellitus. Br J Diabetes Vasc Dis 2011; 11: 137\u2013140. https:\/\/doi.org\/10.1177\/1474651411412863","DOI":"10.1177\/1474651411412863"},{"key":"e_1_3_3_45_2","doi-asserted-by":"crossref","unstructured":"Schernthaner G Matthews DR Charbonnel B et al. Efficacy and safety of pioglitazone versus metformin in patients with type 2 diabetes mellitus: a double-blind randomized trial. J Clin Endocrinol Metab 2004; 89(12): 6068\u20136076. https:\/\/doi.org\/10.1210\/jc.2003-030861","DOI":"10.1210\/jc.2003-030861"},{"key":"e_1_3_3_46_2","doi-asserted-by":"crossref","unstructured":"Schweizer A Couturier A Foley JE et al. Comparison between vildagliptin and metformin to sustain reductions in HbA(1c) over 1 year in drug-na\u00efve patients with type 2 diabetes. Diabet Med 2007; 24(9): 955\u2013961. https:\/\/doi.org\/10.1111\/j.1464-5491.2007.02191.x","DOI":"10.1111\/j.1464-5491.2007.02191.x"},{"issue":"1","key":"e_1_3_3_47_2","first-page":"213","article-title":"Prospective randomized two-years clinical study comparing additional metformin treatment with reducing diet in type 2 diabetes","volume":"17","author":"Teupe B","year":"1991","unstructured":"Teupe B, Bergis K. Prospective randomized two-years clinical study comparing additional metformin treatment with reducing diet in type 2 diabetes. Diabete Metab 1991; 17(1 Pt. 2): 213\u2013217.","journal-title":"Diabete Metab"},{"key":"e_1_3_3_48_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)07037-8"},{"key":"e_1_3_3_49_2","doi-asserted-by":"crossref","unstructured":"Umpierrez G Tof\u00e9 Povedano S P\u00e9rez Manghi F et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care 2014; 37(8): 2168\u20132176. https:\/\/doi.org\/10.2337\/dc13-2759","DOI":"10.2337\/dc13-2759"},{"key":"e_1_3_3_50_2","doi-asserted-by":"crossref","unstructured":"Goldstein BJ Feinglos MN Lunceford JK et al. Effect of initial combination therapy with sitagliptin a dipeptidyl peptidase-4 inhibitor and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care 2007; 30(8): 1979\u20131987. https:\/\/doi.org\/10.2337\/dc07-0627","DOI":"10.2337\/dc07-0627"},{"key":"e_1_3_3_51_2","doi-asserted-by":"crossref","unstructured":"Yamanouchi T Sakai T Igarashi K et al. Comparison of metabolic effects of pioglitazone metformin and glimepiride over 1 year in Japanese patients with newly diagnosed type 2 diabetes. Diabet Med 2005; 22(8): 980\u2013985. https:\/\/doi.org\/10.1111\/j.1464-5491.2005.01656.x","DOI":"10.1111\/j.1464-5491.2005.01656.x"},{"key":"e_1_3_3_52_2","doi-asserted-by":"crossref","unstructured":"Pf\u00fctzner A Paz-Pacheco E Allen E et al. Initial combination therapy with saxagliptin and metformin provides sustained glycaemic control and is well tolerated for up to 76 weeks. Diabetes Obes Metab 2011; 13(6): 567\u2013576. https:\/\/doi.org\/10.1111\/j.1463-1326.2011.01385.x","DOI":"10.1111\/j.1463-1326.2011.01385.x"},{"key":"e_1_3_3_53_2","doi-asserted-by":"crossref","unstructured":"Kahn SE Haffner SM Heise MA et al. Glycemic durability of rosiglitazone metformin or glyburide monotherapy. N Engl J Med 2006; 355: 2427\u20132443. https:\/\/doi.org\/10.1056\/NEJMoa066224","DOI":"10.1056\/NEJMoa066224"},{"key":"e_1_3_3_54_2","doi-asserted-by":"crossref","unstructured":"Amador-Licona N Gu\u00edzar-Mendoza J Vargas E et al. The short-term effect of a switch from glibenclamide to metformin on blood pressure and microalbuminuria in patients with type 2 diabetes mellitus. Arch Med Res 2000; 31(6): 571\u2013575. https:\/\/doi.org\/10.1016\/s0188-4409(00)00241-1","DOI":"10.1016\/S0188-4409(00)00241-1"},{"key":"e_1_3_3_55_2","doi-asserted-by":"crossref","unstructured":"Charpentier G Fleury F Kabir M et al. Improved glycaemic control by addition of glimepiride to metformin monotherapy in type 2 diabetic patients. Diabet Med 2001; 18(10): 828\u2013834. https:\/\/doi.org\/10.1046\/j.1464-5491.2001.00582.x","DOI":"10.1046\/j.1464-5491.2001.00582.x"},{"key":"e_1_3_3_56_2","doi-asserted-by":"crossref","unstructured":"Chiasson JL and Naditch L; Miglitol Canadian University Investigator Group. The synergistic effect of miglitol plus metformin combination therapy in the treatment of type 2 diabetes. Diabetes Care 2001; 24(6): 989\u2013994. https:\/\/doi.org\/10.2337\/diacare.24.6.989","DOI":"10.2337\/diacare.24.6.989"},{"key":"e_1_3_3_57_2","doi-asserted-by":"crossref","unstructured":"DeFronzo RA Goodman AM. Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. The Multicenter Metformin Study Group. N Engl J Med 1995; 333: 541\u2013549. https:\/\/doi.org\/10.1056\/nejm199508313330902","DOI":"10.1056\/NEJM199508313330902"},{"key":"e_1_3_3_58_2","doi-asserted-by":"crossref","unstructured":"Del Prato S Erkelens DW Leutenegger M. Six-month efficacy of benfluorex vs. placebo or metformin in diet-failed type 2 diabetic patients. Acta Diabetol 2003; 40(1): 20\u201327. https:\/\/doi.org\/10.1007\/s005920300004","DOI":"10.1007\/s005920300004"},{"key":"e_1_3_3_59_2","doi-asserted-by":"crossref","unstructured":"Goldstein BJ Pans M Rubin CJ. Multicenter randomized double-masked parallel-group assessment of simultaneous glipizide\/metformin as second-line pharmacologic treatment for patients with type 2 diabetes mellitus that is inadequately controlled by a sulfonylurea. Clin Ther 2003; 25(3): 890\u2013903. https:\/\/doi.org\/10.1016\/s0149-2918(03)80112-1","DOI":"10.1016\/S0149-2918(03)80112-1"},{"key":"e_1_3_3_60_2","doi-asserted-by":"crossref","unstructured":"Horton ES Clinkingbeard C Gatlin M et al. Nateglinide alone and in combination with metformin improves glycemic control by reducing mealtime glucose levels in type 2 diabetes. Diabetes Care 2000; 23(11): 1660\u20131665. https:\/\/doi.org\/10.2337\/diacare.23.11.1660","DOI":"10.2337\/diacare.23.11.1660"},{"key":"e_1_3_3_61_2","doi-asserted-by":"crossref","unstructured":"Mather KJ Verma S Anderson TJ. Improved endothelial function with metformin in type 2 diabetes mellitus. J Am Coll Cardiol 2001; 37: 1344\u20131350. https:\/\/doi.org\/10.1016\/s0735-1097(01)01129-9","DOI":"10.1016\/S0735-1097(01)01129-9"},{"key":"e_1_3_3_62_2","doi-asserted-by":"crossref","unstructured":"Uehara MH Kohlmann NE Zanella MT et al. Metabolic and haemodynamic effects of metformin in patients with type 2 diabetes mellitus and hypertension. Diabetes Obes Metab 2001; 3(5): 319\u2013325. https:\/\/doi.org\/https:\/\/doi.org\/10.1046\/j.1463-1326.2001.00136.x","DOI":"10.1046\/j.1463-1326.2001.00136.x"},{"key":"e_1_3_3_63_2","doi-asserted-by":"publisher","DOI":"10.1002\/0470092602.ch6"},{"key":"e_1_3_3_64_2","doi-asserted-by":"publisher","DOI":"10.3102\/10769986030003261"},{"key":"e_1_3_3_65_2","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-11-22"},{"key":"e_1_3_3_66_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2015.09.005"},{"key":"e_1_3_3_67_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2025.112054"}],"container-title":["Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17407745261467982","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17407745261467982","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17407745261467982","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T17:49:58Z","timestamp":1788198598000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/17407745261467982"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,29]]},"references-count":66,"alternative-id":["10.1177\/17407745261467982"],"URL":"https:\/\/doi.org\/10.1177\/17407745261467982","relation":{},"ISSN":["1740-7745","1740-7753"],"issn-type":[{"value":"1740-7745","type":"print"},{"value":"1740-7753","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,29]]},"article-number":"17407745261467982"}}