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The goal of this article is to describe the baseline characteristics of this hypothesis driven study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and methods<\/jats:title><jats:p>A total of 16\u2009496 diabetic patients from North America (31.9%), Western Europe (26.0%), Eastern Europe (17.3%), Latin America (16.4%) and Asia (8.3%), with either established cardiovascular disease (78.3%) or with \u2265two additional cardiovascular risk factors (21.7%) were randomised to saxagliptin or placebo. Biomarkers of inflammation and insulin resistance were taken at baseline and 2\u2009years later in order to correlate saxagliptin effect on cardiovascular outcome to its effect on inflammation and insulin resistance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Mean [+\/\u2212standard deviation (SD)] age was 65.0 (+\/\u22128.6)\u2009years, 66.9% were male, body mass index was 31.2\u2009kg\/m<jats:sup>2<\/jats:sup> (+\/\u22125.6), mean diabetes duration was 11.9\u2009years (+\/\u22128.9) and the mean HbA<jats:sub>1c<\/jats:sub> 8.0% (+\/\u22121.4%). HbA<jats:sub>1c<\/jats:sub>\u2009&lt;\u20097% was most prevalent among North Americans (30.8%) and least among Asians (15.1%), whereas HbA<jats:sub>1c<\/jats:sub>\u2009&gt;\u20099% was 30.7% in Latin America 27.0% in Asia and 15.1% in North America. Diabetic retinopathy was reported in 12.3% of patients, nephropathy in 17.7% and amputation in 2.5%. Diabetic treatments categories were as follows: no medication (5.4%), 1 oral anti\u2010diabetic drug (OAD) (25.0%), \u22652 OAD (27.7%) and\/or insulin (40.9%). The prevalence of micro\u2010albuminuria was twice as high among insulin users compared with users of \u22652 OAD. Baseline statin use (78.3% overall) varied by region.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The SAVOR\u2010TIMI 53 patient population, with differing background diabetes control and anti\u2010diabetic treatment, provides global representation of diabetic patients with established cardiovascular disease or at high risk for cardiovascular disease and is well\u2010positioned to determine the effect of saxagliptin on cardiovascular events. Copyright \u00a9 2013 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/dmrr.2413","type":"journal-article","created":{"date-parts":[[2013,4,6]],"date-time":"2013-04-06T18:02:40Z","timestamp":1365271360000},"page":"417-426","source":"Crossref","is-referenced-by-count":41,"title":["Baseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)\u2010TIMI 53 trial"],"prefix":"10.1002","volume":"29","author":[{"given":"O.","family":"Mosenzon","sequence":"first","affiliation":[{"name":"Diabetes Unit, Department of Medicine Hadassah University Hospital  Jerusalem Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I.","family":"Raz","sequence":"additional","affiliation":[{"name":"Diabetes Unit, Department of Medicine Hadassah University Hospital  Jerusalem Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B. 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G.","family":"Steg","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Paris\u2010Diderot, Sorbonne Paris\u2010Cit\u00e9, INSERM U\u2010698, CHU Bichat, AP\u2010HP  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Davidson","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Department of Internal Medicine University of Texas Southwestern Medical School  Dallas TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"Ohman","sequence":"additional","affiliation":[{"name":"AstraZeneca Research and Development  Wilmington DE USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D. 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