Table 1. Demographic and Baseline Characteristicsa.
| Characteristic | Placebo (n = 66) | Danuglipron | Total (N = 411) | ||||
|---|---|---|---|---|---|---|---|
| 2.5 mg twice daily (n = 68) | 10 mg twice daily (n = 68) | 40 mg twice daily (n = 71) | 80 mg twice daily (n = 67) | 120 mg twice daily (n = 71) | |||
| Age, mean (SD), y | 57.9 (10.27) | 58.9 (9.30) | 58.1 (9.43) | 59.6 (8.58) | 58.4 (9.18) | 58.8 (9.43) | 58.6 (9.33) |
| Sex | |||||||
| Male | 33 (50) | 38 (56) | 35 (51) | 34 (48) | 35 (52) | 34 (48) | 209 (51) |
| Female | 33 (50) | 30 (44) | 33 (49) | 37 (52) | 32 (48) | 37 (52) | 202 (49) |
| Race | |||||||
| Asian | 5 (8) | 7 (10) | 4 (6) | 6 (8) | 6 (9) | 7 (10) | 35 (9) |
| Black or African American | 2 (3) | 4 (6) | 10 (15) | 6 (8) | 1 (1) | 4 (6) | 27 (7) |
| Pacific Islander | 1 (2) | 0 | 0 | 0 | 0 | 1 (1) | 2 (<1) |
| White | 57 (86) | 57 (84) | 53 (78) | 58 (82) | 59 (88) | 59 (83) | 343 (83) |
| Not reported | 1 (2) | 0 | 1 (1) | 1 (1) | 1 (1) | 0 | 4 (1) |
| Ethnicity | |||||||
| Hispanic or Latino | 24 (36) | 22 (32) | 17 (25) | 24 (34) | 23 (34) | 18 (25) | 128 (31) |
| Otherb | 42 (64) | 46 (68) | 50 (74) | 47 (66) | 44 (66) | 52 (73) | 281 (68) |
| Not reported | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) | 2 (<1) |
| T2D duration, mean (SD), y | 8.8 (6.90) | 8.8 (6.31) | 8.5 (6.85) | 8.0 (5.82) | 9.7 (6.20) | 8.7 (7.89) | 8.8 (6.68) |
| HbA1c, mean (SD), % | 8.24 (0.90) | 8.10 (1.03) | 8.01 (0.91) | 8.00 (0.89) | 8.07 (0.95) | 8.05 (0.86) | 8.07 (0.92) |
| FPG, mean (SD), mg/dL | 173.0 (43.74) | 169.3 (42.40) | 165.4 (39.08) | 166.0 (39.33) | 172.8 (45.47) | 169.5 (40.65) | 169.3 (41.65) |
| Body weight, mean (SD), kgc | 90.1 (17.54) | 90.9 (20.13) | 92.3 (16.44) | 90.2 (18.74) | 91.3 (16.64) | 93.1 (17.95) | 91.3 (17.89) |
| BMI, mean (SD)c | 32.5 (5.08) | 32.5 (5.17) | 33.0 (5.34) | 32.3 (5.25) | 32.9 (5.06) | 33.3 (5.70) | 32.8 (5.25) |
| Metformin use | 62 (94) | 63 (93) | 63 (93) | 63 (89) | 62 (93) | 63 (89) | 376 (91) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; T2D, type 2 diabetes.
SI conversion factors: To convert HbA1c percentage to mmol/mol, multiply by 10.93 and subtract 23.50; to convert FPG to millimoles per liter, multiply by 0.0555.
a
Safety analysis set. Data are presented as number (percentage) of participants unless otherwise indicated.
b
Other includes all ethnicities not identifying as Hispanic or Latino.
c
Values from screening. One participant in the 80-mg twice daily group had missing data.