Table 2. Demographic and Baseline Patient Characteristics.
| Insulin (n = 15) | Insulin + tofogliflozin (n = 19) | Glargine + tofogliflozin (n = 19) | |
|---|---|---|---|
| Mean age (SD), years | 62.0 (10.1) | 54.1 (11.5) | 56.6 (12.5) |
| Male, n (%) | 10 (66.6) | 10 (52.6) | 8 (42.1) |
| Mean weight (SD), kg | 69.8 (15.6) | 83.6 (20.5) | 79.2 (22.1) |
| Mean BMI (SD), kg/m2 | 26.2 (3.9) | 30.2 (5.1) | 29.2 (7.0) |
| Mean duration of type 2 diabetes (SD), years | 17.2 (8.3) | 12.7 (4.2) | 15.3 (5.9) |
| Mean duration of insulin treatment (SD), years | 7.1 (3.3) | 6.8 (2.8) | 6.9 (4.8) |
| Insulin regimen, n (%) | |||
| Basal | 1 (6.6) | 2 (10.5) | 0 (0.0) |
| Mix | 13 (86.6) | 11 (57.9) | 12 (63.1) |
| Bolus + basal | 1 (6.6) | 6 (31.6) | 7 (36.8) |
| Mean total insulin dose (SD), U | 35.9 (16.0) | 42.2 (23.1) | 39.9 (12.1) |
| Background OAD, n (%) | |||
| Sulphonylurea | 2 (13.3) | 5 (26.3) | 4 (21.0) |
| DPP4 inhibitor | 7 (46.6) | 8 (42.1) | 10 (52.6) |
| Metformin | 10 (66.6) | 11 (57.9) | 15 (78.9) |
| Others | 1 (6.7) | 0 (0.0) | 0 (0.0) |
| Mean HbA1c (SD), % | 8.1 (0.3) | 9.0 (1.2) | 8.8 (0.9) |
| Mean fasting plasma glucose (SD), mg/dL | 165.0 (16.6) | 185.5 (24.6) | 171.9 (24.1) |
| Concomitant medications, n (%) | |||
| Antihypertensive agents | 11 (73.3) | 10 (52.6) | 15 (78.9) |
| Lipid-lowering agents | 9 (60.0) | 13 (68.4) | 13 (68.4) |
| Acetylsalicylic acid | 1 (6.6) | 1 (5.2) | 0 (0.0) |
| Mean eGFR (SD), mL/min/1.73 m2 | 85.3 (23.1) | 89.4 (34.6) | 91.7 (29.3) |
| Mean SBP (SD), mm Hg | 126.4 (9.5) | 127.5 (13.7) | 130.5 (5.9) |
| Mean DBP (SD), mm Hg | 74.3 (12.9) | 76.4 (13.3) | 74.6 (10.3) |
| Mean total cholesterol (SD), mg/dL | 173.3 (20.0) | 179.1 (25.3) | 180.6 (26.8) |
| Mean triglycerides (SD), mg/dL | 147.8 (72.2) | 166.6 (114.4) | 152.9 (55.8) |
| Mean LDL cholesterol (SD), mg/dL | 102.2 (19.2) | 103.2 (17.3) | 108.6 (24.2) |
| Mean HDL cholesterol (SD), mg/dL | 54.5 (12.5) | 54.0 (12.5) | 54.5 (10.1) |
n: number of patients in the full analysis set. BMI: body mass index; OAD: oral antidiabetic drug; SD: standard deviation; SBP: systolic blood pressure; DBP: diastolic blood pressure. All characteristics were balanced across the randomized groups at baseline.