Table 2.
Summary statistics of the demographics and laboratory variables of the patients with type 2 diabetes mellitus enrolled in clinical studies on ipragliflozin
| Demographics and laboratory variables | Studies B and C (clinical pharmacology) | Studies D, E, and F (phase II, III) | Study G (phase III) | Total |
|---|---|---|---|---|
| Number of subjects (active/placebo) | 53 (43/10) | 670 (534/136) | 164 (118/46) | 887 (695/192) |
| Gender | ||||
| Male | 37 (69.8%) | 441 (65.8%) | 128 (78.0%) | 606 (68.3%) |
| Female | 16 (30.2%) | 229 (34.2%) | 36 (22.0%) | 281 (31.7%) |
| Age category (years) | ||||
| < 65 | 34 (64.2%) | 482 (71.9%) | 81 (49.4%) | 597 (67.3%) |
| ≥ 65 | 19 (35.8%) | 188 (28.1%) | 83 (50.6%) | 290 (32.7%) |
| Renal function (mL/min/1.73 m2)a | ||||
| Normal (eGFR ≥ 90) | 22 (41.5%) | 296 (44.2%) | 0 (0.0%) | 318 (35.9%) |
| Mild (eGFR 60 to < 90) | 21 (39.6%) | 362 (54.0%) | 83 (50.6%) | 466 (52.5%) |
| Moderate (eGFR 30 to < 60) | 10 (18.9%) | 12 (1.8%) | 81 (49.4%) | 103 (11.6%) |
| Severe (eGFR < 30) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Age (years) | ||||
| Mean (SD) | 59.3 (10.4) | 57.3 (10.3) | 64.4 (6.7) | 58.7 (10.1) |
| Range (Min–Max) | (34–75) | (26–86) | (44–74) | (26–86) |
| Body weight (kg) | ||||
| Mean (SD) | 69.06 (11.89) | 68.06 (12.31) | 68.47 (11.42) | 68.19 (12.11) |
| Range (Min–Max) | (45.6–100.8) | (43.7–128.0) | (41.5–101.5) | (41.5–128.0) |
| BMI (kg/m2) | ||||
| Mean (SD) | 25.78 (3.14) | 25.61 (3.66) | 25.60 (3.44) | 25.62 (3.59) |
| Range (Min–Max) | (20.0–33.9) | (19.1–40.6) | (20.0–35.9) | (19.1–40.6) |
| BSA (m2) | ||||
| Mean (SD) | 1.744 (0.183) | 1.729 (0.181) | 1.738 (0.166) | 1.732 (0.178) |
| Range (Min–Max) | (1.35–2.14) | (1.29–2.47) | (1.28–2.13) | (1.28–2.47) |
| GFR (mL/min/1.73 m2)b | ||||
| Mean (SD) | 84.28 (29.29) | 90.18 (21.65) | 61.29 (14.83) | 84.46 (23.91) |
| Range (Min–Max) | (29.8–169.8) | (50.5–175.4) | (24.1–98.4) | (24.1–181.5) |
| Total protein (g/dL) | ||||
| Mean (SD) | 7.19 (0.47) | 7.26 (0.38) | 7.35 (0.43) | 7.27 (0.40) |
| Range (Min–Max) | (6.1–8.3) | (5.9–8.4) | (5.8–9.1) | (5.8–9.1) |
| Total bilirubin (mg/dL) | ||||
| Mean (SD) | 0.81 (0.33) | 0.82 (0.32) | 0.77 (0.28) | 0.81 (0.31) |
| Range (Min–Max) | (0.4–2.7) | (0.2–3.6) | (0.3–1.8) | (0.2–3.6) |
| Fasted plasma glucose (mg/dL) | ||||
| Mean (SD) | 156.0 (40.2) | 175.2 (38.0) | 144.2 (22.9) | 168.3 (37.9) |
| Range (Min–Max) | (84–255) | (96–342) | (73–207) | (73–342) |
| HbA1c (NGSP) (%) | ||||
| Mean (SD) | 8.05 (1.45) | 8.22 (0.82) | 7.52 (0.54) | 8.08 (0.87) |
| Range (Min–Max) | (5.8–14.0) | (6.7–11.4) | (6.3–9.0) | (5.8–14.0) |
Values in table are presented as the mean with the standard deviation (SD) and range (minimum [Min]–maximum [Max]) in parenthesis, or as a number with the percentage in parenthesis
BMI Body mass index, BSA body surface area, GFR glomerular filtration rate, NGSP National Glycohemoglobin Standardization Program
aIn Study G, the estimated GFR (eGFR) values during the placebo run-in period are presented as baseline values
beGFR values were corrected with individual BSA values