Table 1. Subject demographics.
| Placebo (N = 96) |
600 mg Met DR (N = 94) |
900 mg Met DR (N = 95) |
1200 mg Met DR (N = 96) |
1500 mg Met DR (N = 96) |
2000 mg Met IR (N = 94) |
All Subjects (N = 571) |
|
|---|---|---|---|---|---|---|---|
| Age (y) | |||||||
| Mean (SD) | 57 (11) | 56 (10) | 55 (10) | 55 (11) | 55 (9) | 57 (11) | 56 (11) |
| Sex, (%) | |||||||
| Female / Male | 55 / 45 | 49 / 51 | 40 / 60 | 47 / 53 | 44 / 56 | 48 / 52 | 47 / 53 |
| Race [1], n (%) | |||||||
| American Indian or Alaska Native | 0 | 2 (2) | 0 | 0 | 0 | 2 (2) | 4 (1) |
| Asian | 5 (5) | 4 (4) | 6 (6) | 3 (3) | 3 (3) | 2 (2) | 23 (4) |
| Black or African American | 17 (18) | 14 (15) | 7 (7) | 23 (24) | 19 (20) | 8 (9) | 88 (15) |
| Native Hawaiian or Other Pacific Islander | 1 (1) | 0 | 0 | 0 | 1 (1) | 0 | 2 (<1) |
| White | 72 (75) | 76 (81) | 82 (86) | 70 (73) | 73 (76) | 83 (88) | 456 (80) |
| Other | 1 (1) | 0 | 0 | 0 | 0 | 0 | 1 (<1) |
| Ethnicity, n (%) | |||||||
| Hispanic or Latino | 37 (39) | 36 (38) | 44 (46) | 41 (43) | 42 (44) | 45 (48) | 245 (43) |
| Body Weight (kg) | |||||||
| Mean (SD) | 86 (17) | 94 (20) | 89 (18) | 93 (21) | 95 (22) | 89 (21) | 91 (20) |
| BMI (kg/m2) | |||||||
| Mean (SD) | 31 (5) | 33 (5) | 32 (6) | 32 (6) | 33 (6) | 32 (5) | 32 (5) |
| HbA1c (%) | |||||||
| Mean (SD) | 8.6 (0.9) | 8.6 (0.9) | 8.7 (0.8) | 8.7 (0.9) | 8.6 (0.9) | 8.6 (0.9) | 8.6 (0.9) |
| HbA1c Stratum, n (%) | |||||||
| <8.5% | 45 (47) | 45 (48) | 45 (47) | 46 (48) | 46 (48) | 45 (48) | 272 (48) |
| ≥8.5% | 51 (53) | 49 (52) | 50 (53) | 50 (52) | 50 (52) | 49 (52) | 299 (52) |
| FPG Concentration (mg/dL) | |||||||
| Mean (SD) | 204 (57) | 204 (58) | 202 (45) | 205 (59) | 212 (54) | 200 (50) | 205 (54) |
| Duration of T2DM at Screening (y) | |||||||
| Mean (SD) | 8.3 (7.0) | 6.6 (5.2) | 8.8 (8.0) | 7.3 (6.3) | 7.6 (6.0) | 8.6 (7.1) | 7.9 (6.7) |
| eGFR (mL/min/1.73m2) | |||||||
| Mean (SD) | 96.4 (27.4) | 94.4 (19.1) | 94.5 (22.8) | 96.2 (24.5) | 95.9 (22.8) | 96.2 (22.4) | 95.6 (23.2) |
| eGFR Subgroup, n (%) | |||||||
| <90 mL/min/1.73m2 | 42 (44) | 42 (45) | 46 (48) | 36 (38) | 42 (44) | 43 (46) | 251 (44) |
| ≥90 mL/min/1.73m2 | 54 (56) | 52 (55) | 49 (52) | 60 (63) | 54 (56) | 51 (54) | 320 (56) |
| Metformin Dose Prior to Washout (mg/d) | |||||||
| Mean (SD) | 1689 (515) | 1693 (475) | 1698 (523) | 1493 (550) | 1485 (535) | 1660 (472) | 1622 (516) |
Abbreviations: DR = Delayed-release; eGFR = Estimated glomerular filtration rate; FPG = Fasting plasma glucose; HbA1c = Hemoglobin-specific A1c fraction; IR = Immediate-release; Met = Metformin; T2DM = Type 2 diabetes mellitus.
[1] A subject may contribute more than one race to the summary.