Table 1.
Demographic and baseline characteristics (SAS)
| Parameter | Alogliptin 25 mg QD (n = 75) | Placebo (n = 76) | Total (N = 151) |
|---|---|---|---|
| Age (years), median | 14.0 | 14.0 | 14.0 |
| Age (years), n (%) | |||
| 10–13 | 23 (30.7) | 28 (36.8) | 51 (33.8) |
| 14–17 | 52 (69.3) | 48 (63.2) | 100 (66.2) |
| Sex, n (%) | |||
| Male | 22 (29.3) | 25 (32.9) | 47 (31.1) |
| Female | 53 (70.7) | 51 (67.1) | 104 (68.9) |
| Race, n (%) | |||
| American Indian or Alaska Native | 11 (14.7) | 14 (18.4) | 25 (16.6) |
| Asian | 0 | 1 (1.3) | 1 (0.7) |
| Black or African American | 16 (21.3) | 16 (21.1) | 32 (21.2) |
| White | 44 (58.7) | 44 (57.9) | 88 (58.3) |
| Multiraciala | 4 (5.3) | 1 (1.3) | 5 (3.3) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 9 (12.0) | 6 (7.9) | 15 (9.9) |
| Not Hispanic or Latino | 26 (34.7) | 31 (40.8) | 57 (37.7) |
| Missing | 40 (53.3) | 39 (51.3) | 79 (52.3) |
| BMI (kg/m2), mean (SD) | 33.7 (8.7) | 33.6 (7.9) | 33.7 (8.2) |
| BMI categories (kg/m2), n (%) | |||
| < 25 | 6 (8.0) | 7 (9.2) | 13 (8.6) |
| 25– < 30 | 25 (33.3) | 22 (28.9) | 47 (31.1) |
| ≥ 30 | 44 (58.7) | 47 (61.8) | 91 (60.3) |
| Baseline HbA1c (%), mean (SD) | 8.16 (1.513) | 8.11 (1.330) | 8.13 (1.420) |
| Baseline blood glucose (mmol/l), mean (SD) | 8.8 (3.49) | 8.1 (3.11) | 8.4 (3.31) |
| Glomerular filtration rate (ml/min/1.73 m2), mean (SD) | 147.3 (36.9) | 139.9 (40.5) | 143.6 (38.8) |
| Albumin/creatinine (mg/mmol creatinine), mean (SD) | 4.4 (7.5) | 5.3 (6.5) | 4.8 (7.1) |
| Cholesterol (mmol/l), mean (SD) | 4.1 (0.9) | 4.2 (0.9) | 4.1 (0.9) |
| HDL cholesterol (mmol/l), mean (SD) | 1.0 (0.3) | 0.9 (0.2) | 1.0 (0.2) |
| LDL cholesterol (mmol/l), mean (SD) | 2.6 (0.7) | 2.6 (0.7) | 2.6 (0.7) |
| Triglycerides (mmol/l), mean (SD) | 1.8 (1.0) | 1.9 (1.1) | 1.8 (1.1) |
| Diastolic blood pressure (mmHg), mean (SD) | 74.6 (10.14) | 72.5 (9.89) | 73.5 (10.03) |
| Systolic blood pressure (mmHg), mean (SD) | 118.6 (11.83) | 117.3 (11.94) | 117.9 (11.86) |
| Prior antihypertensive medications, n (%) | 6 (8.0) | 9 (11.8) | 15 (9.9) |
| Prior antihyperglycemic therapy, n (%) | |||
| Schedule A (naïve to antihyperglycemic therapy) | 13 (17.3) | 14 (18.4) | 27 (17.9) |
| Schedule B (entered study on antihyperglycemic therapy) | 62 (82.7) | 62 (81.6) | 124 (82.1) |
BMI body mass index, HbA1c glycosylated hemoglobin, HDL high-density lipoprotein, LDL low-density lipoprotein, QD once daily, SAS safety analysis set, SD standard deviation
aEach participant marked with more than one race was coded as multiracial