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Table 2 Baseline characteristics

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

 

Total (n = 6980)

Age, years

65.8 ± 9.1

Male, n (%)

4390 (62.9)

Race, n (%)

 White

5595 (80.2)

 Asian

641 (9.2)

 Black/African American

411 (5.9)

 Othera

333 (4.8)

Region, n (%)

 Europe

2833 (40.6)

 South America

2310 (33.1)

 North America

1180 (16.9)

 Asia

657 (9.4)

Smoking status, n (%)

 Never smoker

3753 (53.8)

 Ex-smoker

2507 (35.9)

 Current smoker

713 (10.2)

 Missing

7 (0.1)

eGFR (MDRD), mL/min/1.73 m2

54.6 ± 25.0

eGFR (MDRD), n (%)

 ≥ 90 mL/min/1.73 m2

728 (10.4)

 ≥ 60 to < 90 mL/min/1.73 m2

1903 (27.3)

 ≥ 45 to < 60 mL/min/1.73 m2

1349 (19.3)

 ≥ 30 to < 45 mL/min/1.73 m2

1937 (27.8)

 < 30 mL/min/1.73 m2

1063 (15.2)

UACR, mg/g, median (25th–75th percentile)

162 (44–727)c

UACR, n (%) [mg/g]

 < 30

1390 (19.9)

 30–300

2896 (41.5)

 > 300

2691 (38.6)

 Missing

3 (0.0)

BMI, kg/m2

31.3 ± 5.3d

HbA1c, %

7.9 ± 1.0

Fasting plasma glucose, mmol/Lb (mg/dL)

8.4 ± 3.4 (151.8 ± 61.7)e

Diabetes duration, years

14.7 ± 9.5

Systolic blood pressure, mmHg

140.5 ± 17.9

Diastolic blood pressure, mmHg

77.8 ± 10.5

Total cholesterol, mmol/L (mg/dL)

4.5 ± 1.3 (172 ± 48)f

LDL cholesterol, mmol/L (mg/dL)

2.4 ± 1.0 (91 ± 40)g

HDL cholesterol, mmol/L (mg/dL)

1.2 ± 0.3 (45 ± 13)h

Triglycerides, mmol/L (mg/dL)

2.1 ± 1.5 (188 ± 133)f

Glucose-lowering therapy, n (%)

6802 (97.4)

 Metformin

3823 (54.8)

 Sulfonylurea

2434 (34.9)

 Insulin

4039 (57.9)

Antihypertensives, n (%)

6637 (95.1)

 ACE inhibitors or ARBs

5655 (81.0)

 β-blockers

4144 (59.4)

 Diuretics

3711 (53.2)

 Calcium antagonists

2870 (41.1)

Platelet aggregation inhibitors (excluding heparin), n (%)

4764 (68.3)

Statins, n (%)

5010 (71.8)

  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, 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. aAmerican Indian/Alaska Native or Native Hawaiian/other Pacific Islander, b calculated by multiplying mg/dL values by 0.0555 [34], c n = 6977, d n = 6975, e n = 6915; f n = 6749, g n = 6744, h n = 6748