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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