Table 1.
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.