Table 1 Baseline demographic and clinical characteristics
Characteristic | SAXA 2.5 mg q.A.M. (n = 74) | SAXA 5 mg q.A.M. (n = 74) | SAXA 2.5/5 mg q.A.M. (n = 71) | SAXA 5 mg q.P.M. (n = 72) | Placebo (n = 74) |
|---|---|---|---|---|---|
Age, years, mean (SD) | 55.2 (10.44) | 54.7 (9.71) | 54.3 (10.93) | 55.1 (10.35) | 55.6 (10.32) |
Age ≥65 years, n (%) | 16 (21.6) | 12 (16.2) | 12 (16.9) | 11 (15.3) | 13 (17.6) |
Gender, n (%) | |||||
Male | 25 (33.8) | 38 (51.4) | 37 (52.1) | 33 (45.8) | 35 (47.3) |
Female | 49 (66.2) | 36 (48.6) | 34 (47.9) | 39 (54.2) | 39 (52.7) |
Race, n (%) | |||||
White | 50 (67.6) | 49 (66.2) | 54 (76.1) | 48 (66.7) | 53 (71.6) |
Black/African American | 5 (6.8) | 5 (6.8) | 2 (2.8) | 8 (11.1) | 4 (5.4) |
Asian | 18 (24.3) | 20 (27) | 14 (19.7) | 16 (22.2) | 17 (23) |
Other | 1 (1.4) | 0 | 1 (1.4) | 0 | 0 |
Weight, kg, mean (SD) | 83.8 (16.70) | 86.5 (20.71) | 85.4 (17.25) | 83.3 (19.10) | 85.4 (14.40) |
BMI, kg/m2, mean (SD) | 30.4 (4.84) | 31.0 (5.23) | 30.6 (4.72) | 29.6 (5.37) | 31.1 (4.54) |
Duration of diabetes, years, mean (SD) | 1.2 (1.6) | 1.7 (2.4) | 2.0 (2.9) | 2.0 (5.2) | 1.7 (2.8) |
HbA1c, %, mean (SD) | 8.0 (0.8) | 8.0 (0.9) | 8.0 (1.1) | 7.9 (0.9) | 7.8 (1.0) |
<8.0%, n (%) | 40 (54.1) | 40 (54.1) | 37 (52.1) | 38 (52.8) | 47 (63.5) |
≥8.0% to < 9.0%, n (%) | 23 (31.1) | 27 (36.5) | 18 (25.4) | 24 (33.3) | 15 (20.3) |
≥9.0%, n (%) | 11 (14.9) | 7 (9.5) | 16 (22.5) | 10 (13.9) | 12 (16.2) |
FPG, mg/dL, mean (SD) | 158 (33.0) | 162 (35.6) | 171 (51.8) | 160 (44.6) | 160 (46.2) |
Hypertension, n (%) | 40 (54.1) | 36 (48.7) | 48 (67.6) | 41 (56.9) | 47 (63.5) |
Hypercholesterolemia, n (%) | 25 (33.8) | 22 (29.7) | 32 (45.1) | 23 (31.9) | 17 (23.0) |
Mixed dyslipidemia, n (%) | 13 (17.6) | 14 (18.9) | 15 (21.1) | 13 (18.1) | 9 (12.2) |
CHF, n (%) | 6 (8.1) | 8 (10.8) | 7 (9.9) | 4 (5.6) | 7 (9.5) |
Coronary artery disease, n (%) | 9 (12.2) | 8 (10.8) | 15 (21.1) | 8 (11.1) | 9 (12.2) |
Prior MI, n (%) | 4 (5.4) | 2 (2.7) | 5 (7.0) | 4 (5.6) | 4 (5.4) |