Baseline demographic and clinical characteristics of participants
| Variables | Overall (n=1278) |
| Age (years), mean (SD) | 57.4 (11.1) |
| Sex, n (%)* | |
| Women | 585 (45.8) |
| Men | 692 (54.2) |
| Race, n (%)* | |
| White | 1004 (78.6) |
| Black or African-American | 189 (14.8) |
| Native Hawaiian or other Pacific Islander | 5 (0.4) |
| American Indian or Alaska Native, Asian | 43 (3.4) |
| Other | 36 (2.8) |
| Hispanic or Latino, n (%)* | 114 (8.9) |
| Weight (pounds), mean (SD)† | 228.2 (56.6) |
| Body mass index (kg/m2), mean (SD)† | 35.7 (8.0) |
| Systolic blood pressure (mm Hg), mean (SD)‡ | 131.0 (14.5) |
| Diastolic blood pressure (mm Hg), mean±SD‡ | 79.2 (9.1) |
| Comorbid conditions, n (%)*§ | |
| Hypertension | 986 (77.2) |
| Dyslipidemia | 911 (71.3) |
| Hypothyroidism | 204 (16.0) |
| Diabetic neuropathy | 179 (14.0) |
| Ischemic heart disease | 84 (6.6) |
| Myocardial infarction | 30 (2.3) |
| Diabetic nephropathy | 50 (3.9) |
| Peripheral vascular disease | 30 (2.3) |
| Diabetic retinopathy | 25 (2.0) |
| Heart failure | 24 (1.9) |
| Stroke | 19 (1.5) |
| Concomitant cardiovascular medication use, n (%)¶ | |
| Yes | 1081 (84.9) |
| No | 192 (15.1) |
| Concomitant cardiovascular medication type, (reported in >10% of participants), n (%)¶ | |
| Statins | 706 (55.5) |
| ACE inhibitor | 423 (33.2) |
| Angiotensin receptor blockers | 288 (22.6) |
| Beta-blockers | 260 (20.4) |
| Aspirin | 239 (18.8) |
| Calcium channel blockers | 209 (16.4) |
| Thiazide diuretic | 168 (13.2) |
| Diabetes duration (years), mean (SD)* | 7.4 (6.0) |
| Baseline HbA1c (%), mean (SD) | 8.5 (1.6) |
| Baseline HbA1c category n (%) | |
| <8.0 | 582 (45.5) |
| ≥8.0 | 696 (54.5) |
| Individualized HbA1c target (%), mean (SD) | 6.7 (0.5) |
| Difference between baseline HbA1c and individualized HbA1c target (%), mean (SD) | −1.8 (1.5) |
| Participants receiving 1/2/3+ oral antidiabetes medications, n (%)** | |
| 1 | 805 (63.0) |
| 2 | 426 (33.3) |
| 3+ | 18 (1.4) |
| Concomitant oral antidiabetes medications type, n (%)†† | |
| Metformin | 1134 (88.7) |
| Sulfonylureas | 266 (20.8) |
| SGLT-2 inhibitors | 194 (15.2) |
| DPP-4 inhibitors | 139 (10.9) |
| Thiazolidinediones | 34 (2.7) |
| Other | 0 (0.0) |
*Missing data for one participant.
†Missing data for two participants.
‡Missing data for three participants.
§Based on relevant comorbid conditions prespecified in study protocol, participants can contribute to multiple comorbid conditions therefore percentages may exceed 100%.
¶Missing data for five participants.
**Individuals receiving 3+ oral antidiabetes medications are protocol deviations but will be kept in the statistical analysis. 29 participants not included due to reported oral antidiabetic data not meeting definition of baseline (within 4 weeks of randomization) or detailed data missing.
††Defined as any antidiabetes medication being taken within 4 weeks prior to randomization.
DPP-4, dipeptidyl peptidase-4; HbA1c, glycated hemoglobin; SGLT-2, sodium-glucose co-transporter 2.