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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.