Table 1.
Baseline clinical characteristics of patients in both treatment groups
| Parameters | Tofogliflozin group (n = 80) | Conventional group (n = 74) | p value |
|---|---|---|---|
| Sex (males) (%) | 48 (60.0) | 48 (64.9) | 0.53 |
| Age (years) | 61.5 ± 9.2 | 62.5 ± 9.3 | 0.50 |
| Current smoking | 16 (20.0) | 14 (18.9) | 0.87 |
| Body mass index (kg/m2) | 26.4 ± 5.4 | 26.2 ± 4.2 | 0.83 |
| Waist circumference (cm) | 91.2 ± 12.3 (n = 75) | 91.7 ± 10.7 | 0.79 |
| Duration of diabetes (years) | 11.9 ± 8.2 | 14.1 ± 8.7 | 0.11 |
| HbA1c (%) | 7.5 ± 0.7 | 7.4 ± 0.8 | 0.32 |
| Fasting blood glucose (mmol/L) | 8.0 ± 1.8 | 7.9 ± 1.8 (n = 73) | 0.65 |
| C-peptide (ng/mL) | 1.91 ± 1.11 (n = 79) | 1.92 ± 0.89 (n = 73) | 0.96 |
| Hypertension | 38 (47.5) | 49 (66.2) | 0.019 |
| Systolic blood pressure (mmHg) | 130.9 ± 14.4 | 132.4 ± 18.8 | 0.58 |
| Diastolic blood pressure (mmHg) | 79.0 ± 10.0 | 79.6 ± 12.0 | 0.70 |
| Dyslipidemia | 48 (60.0) | 51 (68.9) | 0.31 |
| Total cholesterol (mmol/L) | 5.01 ± 0.77 (n = 79) | 5.07 ± 0.79 (n = 73) | 0.63 |
| LDL cholesterol (mmol/L) | 2.88 ± 0.69 | 3.01 ± 0.66 | 0.25 |
| HDL cholesterol (mmol/L) | 1.47 ± 0.39 | 1.37 ± 0.27 | 0.09 |
| Triglyceride (mmol/L) | 1.07 [0.84, 1.61] | 1.46 (1.02, 1.90) | 0.011 |
| Diabetic retinopathy | 14 (17.9) | 17 (23.3) | 0.43 |
| eGFR (mL/min/1.73 m2) | 79.1 ± 19.9 | 82.0 ± 26.6 | 0.45 |
| Urinary albumin excretion (mg/g/cre) | 9.6 (5.7, 36.8) (n = 75) | 18.7 (5.3, 65.9) (n = 69) | 0.38 |
| Diabetic nephropathy | 24 (30.0) | 27 (36.5) | 0.49 |
| Use of glucose-lowering agents | 69 (86.3) | 61 (82.4) | 0.66 |
| Metformin | 36 (45.0) | 38 (51.4) | 0.52 |
| Sulfonylurea | 16 (20.0) | 14 (18.9) | 1.00 |
| Glinides | 4 (5.0) | 4 (5.4) | 1.00 |
| Thiazolidinediones | 8 (10.0) | 10 (13.5) | 0.62 |
| α-Glucosidase inhibitor | 14 (17.5) | 15 (20.3) | 0.68 |
| DPP-4 inhibitors | 36 (45.0) | 34 (45.9) | 1.00 |
| GLP-1 R agonists | 9 (11.3) | 4 (5.4) | 0.25 |
| Insulin | 12 (15.0) | 16 (21.6) | 0.30 |
| Use of antihypertensive drugs | 36 (45.0) | 46 (62.2) | 0.037 |
| Angiotensin-converting enzyme inhibitors | 1 (1.3) | 4 (5.4) | 0.20 |
| Angiotensin II receptor blockers | 25 (31.3) | 41 (55.4) | 0.003 |
| Direct renin inhibitor | 1 (1.3) | 0 (0.0) | 1.00 |
| Calcium channel blocker | 24 (30.0) | 24 (32.4) | 0.86 |
| Diuretic drugs | 4 (5.0) | 6 (8.1) | 0.52 |
| α-Adrenergic receptor antagonist | 1 (1.3) | 0 (0.0) | 1.00 |
| β-Adrenergic receptor antagonist | 3 (3.8) | 2 (2.7) | 1.00 |
| Others | 0 (0.0) | 0 (0.0) | – |
| Use of lipid-lowering agents | 39 (48.8) | 39 (52.7) | 0.63 |
| Statins | 33 (41.3) | 32 (42.3) | 0.87 |
| Ezetimibe | 4 (5.0) | 5 (6.8) | 0.74 |
| Resins | 0 (0.0) | 0 (0.0) | – |
| Fibrates | 4 (5.0) | 2 (2.7) | 0.68 |
| Use of antithrombotic agents | 11 (13.8) | 11 (14.9) | 1.00 |
| Antiplatelet agents | 10 (12.5) | 9 (12.2) | 1.00 |
| Anticoagulants | 1 (1.3) | 2 (2.7) | 0.61 |
| Others | 0 (0.0) | 0 (0.0) | – |
| Right baPWV (cm/s) | 1690.1 ± 399.2 | 1680.4 ± 323.6 | 0.87 |
| Left baPWV (cm/s) | 1696.2 ± 432.7 | 1672.8 ± 338.0 | 0.71 |
| Mean baPWV (cm/s) | 1693.2 ± 410.3 | 1676.6 ± 324.6 | 0.78 |
Data are presented as the number (%) of patients, mean ± standard deviation (SD) values, or median (the 25th and 75th percentiles) values
HbA1C glycated hemoglobin, SD standard deviation, LDL low-density lipoprotein, HDL high-density lipoprotein, DPP-4 dipeptidyl peptidase, GLP glucagon-like peptide-1, baPWV brachial-ankle pulse wave velocity