Table 1.
Characteristics by sex of GRADE participants at initial run-in and findings at the final run-in visit
| All | Female | Male | P value | |
|---|---|---|---|---|
| Characteristics at initial run-in visit | ||||
| N | 6,823 | 2,519 | 4,304 | |
| Age (years)* | 56.1 ± 10.1 | 54.5 ± 9.7 | 57.1 ± 10.2 | <0.001 |
| Duration of run-in (weeks) | 7.9 ± 2.4 | 8.1 ± 2.5 | 7.8 ± 2.3 | <0.001 |
| Race | <0.001 | |||
| Caucasian | 4,319 (63.3) | 1,350 (53.6) | 2,969 (69.0) | |
| Native American | 193 (2.8) | 112 (4.4) | 81 (1.9) | |
| Asian | 240 (3.5) | 61 (2.4) | 179 (4.2) | |
| Hawaiian/Pacific Islander | 47 (0.7) | 9 (0.4) | 38 (0.9) | |
| African American | 1,478 (21.7) | 747 (29.7) | 731 (17.0) | |
| Other/multiple | 450 (6.6) | 200 (7.9) | 250 (5.8) | |
| Unknown/not reported | 96 (1.4) | 40 (1.6) | 56 (1.3) | |
| Hispanic | 1,302 (19.2) | 601 (24.1) | 701 (16.4) | <0.001 |
| Weight (kg) | 100.3 ± 22.5 | 93.4 ± 21.7 | 104.4 ± 21.9 | <0.001 |
| Height (cm) | 170.3 ± 10.0 | 161.6 ± 7.1 | 175.5 ± 7.5 | <0.001 |
| BMI (kg/m2) | 34.5 ± 6.8 | 35.6 ± 7.4 | 33.9 ± 6.3 | <0.001 |
| Creatinine (mg/dL) | 0.82 ± 0.20 | 0.69 ± 0.16 | 0.90 ± 0.18 | <0.001 |
| Lipids (mg/dL)* | ||||
| Total cholesterol | 163.8 ± 37.8 | 172.7 ± 37.1 | 158.7 ± 37.2 | <0.001 |
| HDL | 43.3 ± 12.1 | 48.2 ± 13.0 | 40.5 ± 10.6 | <0.001 |
| LDL | 90.7 ± 31.5 | 96.4 ± 32.0 | 87.3 ± 30.7 | <0.001 |
| Triglycerides | 125.0 (88.0, 184.0) | 122.0 (86.0, 175.0) | 128.0 (89.0, 190.0) | <0.001 |
| HbA1c (%) at screening visit | 8.1 ± 1.2 | 8.1 ± 1.2 | 8.1 ± 1.2 | 0.509 |
| Metformin dose (mg/day) at screening visit | <0.001 | |||
| <1,000 | 516 (7.6) | 204 (8.1) | 312 (7.2) | |
| 1,000–1,499 | 2,115 (31.0) | 861 (34.2) | 1,254 (29.1) | |
| 1,500–1,999 | 672 (9.8) | 229 (9.1) | 443 (10.3) | |
| 2,000 | 3,424 (50.2) | 1,201 (47.7) | 2,223 (51.6) | |
| ≥2,000 | 96 (1.4) | 24 (1.0) | 72 (1.7) | |
| Findings at final run-in visit | ||||
| HbA1c (%) | ||||
| Final run-in visit | 7.6 ± 0.9 | 7.6 ± 0.9 | 7.6 ± 0.9 | 0.523 |
| Change | −0.52 ± 0.94 | −0.51 ± 0.91 | −0.52 ± 0.95 | 0.822 |
| Weight change (kg) during run-in | −0.74 ± 2.10 | −0.70 ± 1.95 | −0.77 ± 2.19 | 0.185 |
| Metformin dose (mg/day) | ||||
| Final run-in visit | <0.001 | |||
| <1,000 | 2 (0.0) | 0 (0.0%) | 2 (0.0) | |
| 1,000–1,499 | 284 (4.2) | 133 (5.3%) | 151 (3.5) | |
| 1,500–1,999 | 348 (5.1) | 188 (7.5%) | 160 (3.7) | |
| 2,000 | 6,189 (90.7) | 2,198 (87.3%) | 3,991 (92.7) | |
| Change | <0.001 | |||
| Reduced | 192 (2.8) | 70 (2.8) | 122 (2.8) | |
| Unchanged | 3,548 (52.0) | 1,250 (49.6) | 2,298 (53.4) | |
| <500 | 193 (2.8) | 53 (2.1) | 140 (3.3) | |
| 500–999 | 721 (10.6) | 321 (12.7) | 400 (9.3) | |
| ≥1,000 | 2,169 (31.8) | 825 (32.8) | 1,344 (31.2) | |
| Metformin type at final run-in | <0.001 | |||
| IR | 4,665 (68.4) | 1,596 (63.4) | 3,069 (71.3) | |
| XR | 2,158 (31.6) | 923 (36.6) | 1,235 (28.7) | |
| Percent of pills missed last week | <0.001 | |||
| 0 | 4,852 (71.1) | 1,725 (68.5) | 3,127 (72.7) | |
| 0–20 | 1,848 (27.1) | 749 (29.7) | 1,099 (25.5) | |
| >20 | 120 (1.8) | 44 (1.7) | 76 (1.8) |
Continuous variables are shown as the mean ± SD with a P value comparing males to females based on a two-sample t test with unequal variances. As an exception, triglycerides are shown as median (interquartile range) and analyzed by nonparametric rank test due to skew in the data. For categorical values, the table shows the number of participants and percentages for each category and a χ2 P value comparing males to females. HbA1c values in percentage units can be converted to millimoles per mole using the NGSP HbA1c converter at https://www.ngsp.org/convert1.asp.
Age is indicated as reported at screening. Lipid measurements were carried out only at randomization, so HDL, LDL, and triglyceride values exclude 1,784 of the 6,823 participants who completed run-in but were not randomized.