Table 1.
Patient characteristics (full analysis set)
| Ipragliflozin | Placebo | |
|---|---|---|
| No. of patients | 118* | 46 |
| Sex, n (%) | ||
| Males | 92 (78.0) | 36 (78.3) |
| Females | 26 (22.0) | 10 (21.7) |
| Age† , years, mean ± s.d. | 63.9 ± 6.59 | 65.7 ± 6.93 |
| <65 years | 63 (53.4) | 18 (39.1) |
| ≥65 years | 55 (46.6) | 28 (60.9) |
| Body weight‡, kg, mean ± s.d. | 69.16 ± 11.571 | 66.70 ± 10.940 |
| BMI‡, kg/m2, mean ± s.d. | 25.84 ± 3.450 | 24.96 ± 3.362 |
| <25 kg/m2 | 54 (45.8) | 29 (63.0) |
| ≥25 kg/m2 | 64 (54.2) | 17 (37.0) |
| Duration of diabetes‡, months, mean ± s.d. | 114.3 ± 92.26 | 113.0 ± 99.77 |
| Duration of diabetes, n (%) | ||
| <60 months | 34 (29.8) | 14 (33.3) |
| ≥60 months | 80 (70.2) | 28 (66.7) |
| Concurrent hypertension†, n (%) | ||
| Absent | 27 (22.9) | 15 (32.6) |
| Present | 91 (77.1) | 31 (67.4) |
| Systolic blood pressure§, mmHg, mean ± s.d. | 133.0 ± 12.48 | 134.1 ± 12.41 |
| Diastolic blood pressure§, mmHg, mean ± s.d. | 78.2 ± 8.61 | 74.8 ± 10.12 |
| Smoking history†, n (%) | ||
| No history of smoking | 43 (36.4) | 14 (30.4) |
| Ex‐smoker | 55 (46.6) | 24 (52.2) |
| Current smoker | 20 (16.9) | 8 (17.4) |
| Concomitant oral hypoglycaemic agents‡, n (%) | ||
| Absent | 36 (30.5) | 10 (21.7) |
| Present | 82 (69.5) | 36 (78.3) |
| Type of concomitant oral hypoglycaemic agents‡, n (%) | ||
| α‐glucosidase inhibitor | 15 (12.7) | 9 (19.6) |
| Sulfonylurea | 52 (44.1) | 20 (43.5) |
| Pioglitazone | 15 (12.7) | 7 (15.2) |
| Severity of renal impairment¶, **, n (%) | ||
| Mild | 60 (50.8) | 23 (50.0) |
| Moderate | 58 (49.2) | 23 (50.0) |
| HbA1c¶, %, NGSP, mean ± s.d. | 7.53 ± 0.538 | 7.55 ± 0.526 |
| FPG¶, [mmol/l (mg/dl)], mean ± s.d. | 8.11 ± 1.335 (144.3 ± 22.63) | 8.23 ± 1.373 (143.8 ± 23.89) |
| eGFR¶, ml/min/1.73 m2, mean ± s.d. | 60.2 ± 13.08 | 62.7 ± 13.13 |
| eGFR, n (%) | ||
| <60 ml/min/1.73 m2 | 57 (48.3) | 22 (47.8) |
| ≥60 ml/min/1.73 m2 | 61 (51.7) | 24 (52.2) |
eGFR, estimated glomerular filtration rate; FPG, fasting plasma glucose; HbA1c, glycated haemoglobin; NGSP, National Glycohemoglobin Standardization Program; RI, renal impairment; s.d., standard deviation.
*
One patient with mild RI in the ipragliflozin group lacked efficacy data in treatment period 1 and was excluded from the full analysis set.
†
At the time of informed consent.
‡
At screening.
§
At the start of treatment period 1.
¶
During the placebo run‐in period.
**
The severity of RI was rated as mild (eGFR 60 to <90 ml/min/1.73 m2) or moderate (eGFR 30 to <60 ml/min/1.73 m2) based on eGFR measured at visit 2.