Table 1.
Baseline characteristics and medications of clinical trial cohort
| Placebo | Ertugliflozin | P Value | |
|---|---|---|---|
| N | 69 | 162 | |
| Age | 66.0 (61.0–73.0) | 67.0 (62.0–73.0) | 0.7565 |
| Sex–male (%) | 30 (43.4) | 84 (51.9) | 0.2539 |
| BMI | 32.8 (29.8–37.1) | 31.5 (28.1–35.9) | 0.2633 |
| Body weight (kg) | 86.7 (75.7–106.9) | 88.9 (74.0–101.5) | 0.7905 |
| Duration type 2 diabetes (yr) | 12.5 (7.6–15.6) | 13.1 (7.0–18.8) | 0.4528 |
| Race | 0.5659 | ||
| Asian | 7 (10.1) | 16 (9.9) | |
| Black | 2 (2.9) | 7 (4.3) | |
| Multiple | 4 (5.8) | 13 (8.0) | |
| White | 55 (79.7) | 126 (77.8) | |
| Others | 1 (1.5) | 0 (0) | |
| History of CVD | 32 (46.4) | 81 (50.0) | 0.6141 |
| History of HF | 1 (1.4) | 3 (1.9) | |
| Baseline FPG | 150.0 (118.0–168.0) | 153.0 (121.0–183.0) | 0.3224 |
| Baseline eGFR | 45.0 (40.0–53.0) | 49.0 (44.0–53.0) | 0.0885 |
| Baseline HbA1c (%) | 8.0 (7.5–8.4) | 8.0 (7.5–8.5) | 0.9562 |
| Baseline blood albumin (g/dL) | 4.3 (4.0–4.5) | 4.3 (4.1–4.6) | 0.3850 |
| Baseline UACR (mg/g) | 32.0 (8.0–103.0) | 26.5 (9.0–191.0) | 0.4029 |
| Normoalbuminuria (UACR<30 mg/g) | 32 (48.5) | 81 (50.6) | |
| Microalbuminuria (UACR >30 mg/g ≤300 mg/g) | 26 (39.4) | 45 (28.1) | |
| Macroalbuminuria (UACR >300 mg/g) | 8 (12.1) | 34 (21.3) | |
| Baseline medications | |||
| Antihyperglycemic | 67 (97.1) | 153 (93.2) | 0.3538 |
| DPP4i | 8 (11.6) | 19 (11.7) | |
| Insulin | 43 (62.3) | 95 (58.6) | |
| Sulfonylureas | 29 (42.0) | 61 (37.7) | |
| Biguanides | 16 (23.2) | 35 (21.6) | |
| Antihypertensive | 65 (94.2) | 159 (98.2) | 0.2011 |
| Alpha/beta blockers | 42 (60.9) | 102 (63.0) | |
| Diuretics | 46 (66.7) | 90 (55.6) | |
| Calcium channel blockers | 22 (31.9) | 61 (37.7) | |
| Other antihypertensive | 3 (4.3) | 9 (5.6) | |
| RAS blockade | 57 (82.6) | 145 (89.5) | 0.1919 |
| ACEi | 35 (50.7) | 82 (50.6) | |
| ARBs | 25 (36.2) | 67 (41.4) | |
| MRAs | 3 (4.3) | 7 (4.3) | |
| Lipid lowering | 51 (73.9) | 136 (84.0) | 0.0986 |
| Statins | 47 (68.1) | 120 (74.1) | |
| Bile acid sequestrants | 1 (1.4) | 2 (1.2) | |
| Fibrates | 12 (17.4) | 32 (19.8) | |
| Nicotinic acid and derivatives | 1 (1.4) | 0 (0.0) | |
| Other lipid modifying agents | 12 (17.4) | 10 (6.2) | |
| Antithrombotic | 39 (56.5) | 104 (64.2) | 0.3015 |
ARBs, angiotensin II receptor blockers; ACEi, angiotensin-converting enzyme inhibitor; BMI, body mass index; CVD, cardiovascular disease; DPP4i, dipeptidyl peptidase 4 inhibitor; eGFR, glomerular filtration rate; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; HF, heart failure; MRAs, mineralocorticoid receptor antagonists; UACR, urine albumin to creatine ratio.
Continuous variables are presented as medians (interquartile range), and categoric variables are presented as n (%). Continuous variables: Kruskal-Wallis test (multilevel Wilcoxon rank sum test) across 2 categories; categoric variables: chi-square test. Antithrombotic medications include direct factor Xa inhibitors, direct thrombin inhibitors, salicylic acid and derivatives, and platelet aggregation inhibitors, excluding heparin. Diuretics include loop diuretics (42%) and thiazide diuretics (58%).