Table 1.
Characteristics of the safety population at baseline
| Monotherapy (n = 83) | SU concomitant therapy (n = 86) | Total (n = 169) | |
|---|---|---|---|
| Male/female | 51/32 | 48/38 | 99/70 |
| Age (years) | 58.0 ± 9.2 | 61.3 ± 9.7 | 59.7 ± 9.6 |
| <40 | 1(1.2) | 2(2.3) | 3(1.8) |
| ≥40 to <50 | 16(19.3) | 7(8.1) | 23(13.6) |
| ≥50 to <60 | 26(31.3) | 25(29.1) | 51(30.2) |
| ≥60 to <70 | 34(41.0) | 36(41.9) | 70(41.4) |
| ≥70 | 6(7.2) | 16(18.6) | 22(13.0) |
| <65 | 61(73.5) | 48(55.8) | 109(64.5) |
| ≥65 | 22(26.5) | 38(44.2) | 60(35.5) |
| Diabetes duration (years) | 5.4 ± 6.8 | 8.9 ± 7.2 | 7.2 ± 7.2 |
| BMI (kg/m2) | 25.56 ± 4.11 | 25.07 ± 3.83 | 25.31 ± 3.96 |
| <25 | 42(50.6) | 46(53.5) | 88(52.1) |
| ≥25 | 41(49.4) | 40(46.5) | 81(47.9) |
| HbA1c (NGSP) (%) | 7.72 ± 0.85 | 7.96 ± 0.91 | 7.84 ± 0.88 |
| <7.4 | 34(41.0) | 25(29.1) | 59(34.9) |
| ≥7.4 to <8.4 | 31(37.3) | 36(41.9) | 67(39.6) |
| ≥8.4 <9.4 | 15(18.1) | 19(22.1) | 34(20.1) |
| ≥9.4 to <10.5 | 3(3.6) | 5(5.8) | 8(4.7) |
| ≥10.5 to <11.5 | 0(0.0) | 0(0.0) | 0(0.0) |
| ≥11.5 | 0(0.0) | 1(1.2) | 1(0.6) |
| GA (%) | 21.73 ± 3.65 | 23.29 ± 3.96 | 22.52 ± 3.88 |
| FPG (mg/dl) | 148.8 ± 33.6 | 161.1 ± 48.7 | 155.1 ± 42.3 |
| IRI (μU/ml) | 7.23 ± 4.40 | 7.87 ± 5.93 | 7.56 ± 5.23 |
Data are mean ± standard deviation or n (%)
BMI body mass index, HbA1c hemoglobin A1c, NGSP National Glycohemoglobin Standardization Program, GA glycoalbumin, FPG fasting plasma glucose, IRI immunoreactive insulin, SU sulfonylurea