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Table 3 Baseline characteristics by prevalent kidney disease at baseline

From: Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA®): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk

  Prevalent CKDa (n = 5148) No prevalent CKD (n = 1832)
Age, years 66.8 ± 9.0 62.9 ± 8.8
Male, n (%) 3114 (60.5) 1276 (69.7)
Race, n (%)
 White 4042 (78.5) 1553 (84.8)
 Asian 508 (9.9) 133 (7.3)
 Black/African American 349 (6.8) 62 (3.4)
 Otherb 249 (4.8) 84 (4.6)
Region, n (%)
 Europe 1997 (38.8) 836 (45.6)
 South America 1658 (32.2) 652 (35.6)
 North America 984 (19.1) 196 (10.7)
 Asia 509 (9.9) 148 (8.1)
Smoking status, n (%)
 Never smoker 2821 (54.8) 932 (50.9)
 Ex-smoker 1861 (36.1) 646 (35.3)
 Current smoker 461 (9.0) 252 (13.8)
 Missing 5 (0.1) 2 (0.1)
eGFR (MDRD), mL/min/1.73 m2 44.6 ± 19.2 82.6 ± 16.9
eGFR (MDRD), n (%)
 ≥ 90 mL/min/1.73 m2 179 (3.5) 549 (30.0)
 ≥ 60 to < 90 mL/min/1.73 m2 620 (12.0) 1283 (70.0)
 ≥ 45 to < 60 mL/min/1.73 m2 1349 (26.2) 0
 ≥ 30 to < 45 mL/min/1.73 m2 1937 (37.6) 0
 < 30 mL/min/1.73 m2 1063 (20.6) 0
UACR, mg/g, median (25th–75th percentile) 336 (60–1126)d 70 (27–138)j
UACR, n (%) [mg/g]
 < 30 907 (17.6) 483 (26.4)
 30–300 1548 (30.1) 1348 (73.6)
 > 300 2691 (52.3) 0
BMI, kg/m2 31.4 ± 5.4e 31.0 ± 5.1
HbA1c, % 7.9 ± 1.0 8.0 ± 1.0
Fasting plasma glucose, mmol/Lc (mg/dL) 8.3 ± 2.6 (150.1 ± 47.5)f 8.7 ± 5.0 (156.5 ± 90.3)k
Diabetes duration, years 15.9 ± 9.6 11.6 ± 8.4
Systolic blood pressure, mmHg 141.7 ± 18.5 137.2 ± 15.3
Diastolic blood pressure, mmHg 77.5 ± 10.8 78.8 ± 9.5
Total cholesterol, mmol/L (mg/dL) 4.5 ± 1.3 (173 ± 50)g 4.4 ± 1.2 (168 ± 44)l
LDL cholesterol, mmol/L (mg/dL) 2.4 ± 1.1 (92 ± 40)h 2.3 ± 1.0 (90 ± 37)m
HDL cholesterol, mmol/L (mg/dL) 1.2 ± 0.3 (45 ± 13)i 1.1 ± 0.3 (44 ± 12)l
Triglycerides, mmol/L (mg/dL) 2.2 ± 1.5 (191 ± 136)g 2.0 ± 1.4 (181 ± 125)l
Glucose-lowering therapy, n (%) 5013 (97.4) 1789 (97.7)
 Metformin 2350 (45.6) 1473 (80.4)
 Sulfonylurea 1653 (32.1) 781 (42.6)
 Insulin 3294 (64.0) 745 (40.7)
Antihypertensives, n (%) 4946 (96.1) 1691 (92.3)
 ACE inhibitors or ARBs 4183 (81.3) 1472 (80.3)
 β-blockers 3043 (59.1) 1101 (60.1)
 Diuretics 3032 (58.9) 679 (37.1)
 Calcium antagonists 2313 (44.9) 557 (30.4)
Platelet aggregation inhibitors (excluding heparin), n (%) 3365 (65.4) 1399 (76.4)
Statins, n (%) 3708 (72.0) 1302 (71.1)
  1. Data are mean ± SD unless otherwise specified, and may change slightly when the trial is completed
  2. ACE angiotensin-converting enzyme, ARB angiotensin-receptor blocker, BMI body-mass index, CKD chronic kidney disease, eGFR estimated glomerular filtration rate, HbA1c glycated hemoglobin A1c, HDL high-density lipoprotein, LDL low-density lipoprotein, MDRD Modification of Diet in Renal Disease study equation, UACR urinary albumin-to-creatinine ratio
  3. aDefined as eGFR < 60 mL/min/1.73 m2 or macroalbuminuria (UACR > 300 mg/g), b American Indian/Alaska Native or Native Hawaiian/other Pacific Islander, c calculated by multiplying mg/dL values by 0.0555 [34], d n = 5146, e n = 5143, f n = 5097, g n = 4971, h n = 4967, i n = 4970, j n = 1831, k n = 1818, l n = 1778, m n = 1777