Table 1:
Baseline Characteristics by Randomization Status.
| Bexagliflozin, 20 mg (N=157) |
Placebo (N=155) |
Total (N=312) |
|
|---|---|---|---|
|
| |||
| Gender, n (%) | |||
| Woman | 65 (41.4) | 51 (32.9) | 116 (37.2) |
| Man | 92 (58.6) | 104 (67.1) | 196 (62.8) |
|
| |||
| Age (years) Mean (SD) | 69.3 (8.36) | 69.9 (8.29) | 69.6 (8.32) |
|
| |||
| Race, n (%) | |||
| White | 83 (52.9) | 88 (56.8) | 171 (54.8) |
| Black or African-American | 9 (5.7) | 6 (3.9) | 15 (4.8) |
| Asian | 61 (38.9) | 59 (38.1) | 120 (38.5) |
| Other | 4 (2.5) | 2 (1.3) | 6 (1.9) |
|
| |||
| Country of Investigational Site | |||
| France | 12 (7.6) | 16 (10.3) | 28 (9.0) |
| Spain | 34 (21.7) | 31 (20.0) | 65 (20.8) |
| USA | 53 (33.8) | 50 (32.3) | 103 (33.0) |
| Japan | 58 (36.9) | 58 (37.4) | 116 (37.2) |
|
| |||
| BMI, Mean (SD) | 30.29 (5.988) | 30.10 (5.774) | 30.20 (5.874) |
|
| |||
| Body Weight (kg), Mean (SD) | 82.90 (20.509) | 82.59 (21.196) | 82.75 (20.820) |
|
| |||
| SBP (mm Hg), Mean (SD) | 135.9 (14.25) | 137.6 (14.75) | 136.8 (14.50) |
|
| |||
| Hemoglobin A1c (%), Mean (SD) | 8.01 (0.786) | 7.95 (0.812) | 7.98 (0.798) |
|
| |||
| Hemoglobin A1c Group, n (%) | |||
| 7.0 to 8.5% | 124 (79.0) | 123 (79.4) | 247 (79.2) |
| 8.6 to 10.5% | 33 (21.0) | 32 (20.6) | 65 (20.8) |
|
| |||
| Fasting Plasma Glucose (mmol L−1), Mean (SD) | 8.61 (2.525) | 8.63 (2.246) | 8.62 (2.387) |
|
| |||
| Subjects in eGFR Sub-group at Baseline, n (%)1 | |||
| Stage 3a CKD: eGFR 45 to <60 | 86 (54.8) | 80 (51.6) | 166 (53.2) |
| Stage 3b CKD: eGFR 30 to <45 | 71 (45.2) | 75 (48.4) | 146 (46.8) |
|
| |||
| eGFR (mL min−1 per 1.73 m2), Mean (SD) | 45.44 (8.565) | 44.78 (8.085) | 45.11(8.323) |
|
| |||
| eGFR (mL min−1 per 1.73 m2), Mean (SD) Sub-group | |||
| eGFR 45 to <60: Stage 3a CKD | 51.76 (5.307) | 51.27 (4.404) | 51.52 (4.884) |
| eGFR 30 to <45: Stage 3b CKD | 37.79 (4.572) | 37.87 (4.629) | 37.83 (4.586) |
|
| |||
| UACR Group, n (%) | |||
| Normoalbuminuria (UACR<30 mg g−1) | 61 (38.9) | 55 (35.5) | 116 (37.2) |
| Microalbuminuria (≥ 30 and <300 mg g−1) | 65 (41.4) | 53 (34.2) | 118 (37.8) |
| Macroalbuminuria (≥ 300 mg g−1) | 31 (19.7) | 47 (30.3) | 78 (25.0) |
|
| |||
| Duration of Diabetes, Mean (SD) (years) | 15.54 (9.198) | 16.28 (8.977) | 15.91 (9.082) |
|
| |||
| Anti-diabetic Treatment, n (%) | |||
| Insulin | 86 (54.8) | 88 (56.8) | 174 (55.8) |
| Alpha Glucosidase Inhibitors | 8 (5.1) | 2 (1.3) | 10 (3.2) |
| Biguanides | 57 (36.3) | 73 (47.1) | 130 (41.7) |
| Dipeptidyl Peptidase 4 Inhibitors | 71 (45.2) | 59 (38.1) | 130 (41.7) |
| Glucagon-like Peptide-1 Receptor Agonists | 16 (10.2) | 11 (7.1) | 27 (8.7) |
| Meglitinides | 11 (7.0) | 12 (7.7) | 23 (7.4) |
| Sulfonylureas | 35 (22.3) | 34 (21.9) | 69 (22.1) |
| Thiazolidinediones | 13 (8.3) | 10 (6.5) | 23 (7.4) |
| Combination Oral Agents | 6 (3.8) | 6 (3.9) | 12 (3.8) |
Abbreviations: BMI = body mass index; CKD = chronic kidney disease; SBP = systolic blood pressure; SD = standard deviation; UACR = Urine Albumin-to-Creatinine Ratio. eGFR = estimated glomerular filtration rate.