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Table 4 Baseline characteristics (treated set: n=1545)

From: Rationale, design and baseline characteristics of a 4-year (208-week) phase III trial of empagliflozin, an SGLT2 inhibitor, versus glimepiride as add-on to metformin in patients with type 2 diabetes mellitus with insufficient glycemic control

Gender, n (%)  
 Male 854 (55.3)
Race, n (%)  
 Caucasian 1017 (65.8)
 Asian 507 (32.8)
 Black/African-American 20 (1.3)
 Hawaiian/Pacific Islander 1 (0.1)
Ethnicity, n (%)  
 Non-Hispanic/Latino 1233 (79.8)
 Hispanic/Latino 312 (20.2)
Region, n (%)  
 Europe/South Africa 639 (41.4)
 Asia 434 (28.1)
 Latin America 276 (17.9)
 North America 196 (12.7)
Age (years), mean (SD) 55.9 (10.4)
Time (years) since diagnosis of T2DM, n (%)  
 ≤1 172 (11.1)
 >1 to 5 677 (43.8)
 >5 to 10 425 (27.5)
 >10 271 (17.5)
Body weight (kg), mean (SD) 82.8 (19.2)
Body mass index (kg/m2), mean (SD) 30.1 (5.3)
Body mass index (kg/m2), n (%)  
 <25 243 (15.7)
 25 to <30 587 (38.0)
 30 to <35 434 (28.1)
 ≥35 281 (18.2)
Waist circumference (cm), mean (SD)  
 Male 104.1 (13.0)
 Female 98.8 (12.8)
HbA1c (%), mean (SD) 7.9 (0.8)
HbA1c (%), n (%)  
 <8.5 1173 (75.9)
 ≥8.5 372 (24.1)
Fasting plasma glucose (mg/dL), mean (SD) 149.9 (33.9)a
HOMA-IR (mU/L x mmol/L), mean (SD) 6.03 (5.31)b
HOMA-B (mU/mmol), mean (SD) 77.0 (79.0)c
Cardiovascular medications, n (%) 1174 (76.0)
 Antihypertensive agents 933 (60.4)
 Lipid lowering agents 805 (52.1)
 Acetylsalicylic acid 498 (32.2)
Systolic blood pressure (mmHg), mean (SD) 133.5 (15.9)
Diastolic blood pressure (mmHg), mean (SD) 79.5 (9.4)
Blood pressure controlled (<130/80 mmHg), n (%)  
 Yes 486 (31.5)
 No 1059 (68.5)
Serum lipids (mmol/L), mean (SD)  
 Total cholesterold 4.49 (1.01)
 HDL-cholesterole 1.25 (0.31)
 LDL-cholesterolf 2.42 (0.86)
 Triglyceridese 1.86 (1.29)
Markers of renal function and damage  
 eGFR (mL/min/1.73 m2) according to MDRD, mean (SD) 88.0 (17.3)
 eGFR (mL/min/1.73 m2) according to MDRD, n (%)  
  ≥90 (normal renal function) 633 (41.0)
  60 to <90 (mild renal impairment) 877 (56.8)
  30 to <60 (moderate renal impairment) 35 (2.3)
 Urine albumin/creatinine ratio (mg/g), mean (SD) 40.22 (135.59)
 Urine albumin/creatinine ratio (mg/g), n (%)  
  <30 (normal) 1221 (79.0)
  30 to <300 (microalbuminuria) 289 (18.7)
  ≥300 (macroalbuminuria) 35 (2.3)
  1. Legend: T2DM type 2 diabetes mellitus, HbA 1c glycosylated hemoglobin, HOMA-IR homeostasis model assessment of insulin resistance, HOMA-B homeostasis model assessment of beta-cell function, eGFR estimated glomerular filtration rate, MDRD Modified Diet Renal Disease formula. an=1543; bn=1441; cn=1440; dn=1518; en=1517; fn=1516.