Table 1.
Demographic characteristics of data from matched and unmatched subjects from SUSTAIN and PIONEER phase 3a trials
| Category | PIONEER |
SUSTAIN (N = 1,551) | |
|---|---|---|---|
| Unmatched (N = 3,003) | Matched (N = 1,551) | ||
| Age, y | 59.4 ± 10.9 | 57.3 ± 10∙5 | 56.0 ± 10.6 |
| Female | 1,345 (44.8) | 653 (42.1) | 658 (42.4) |
| HbA1c, % | 8.1 ± 0.8 | 8.1 ± 0.9 | 8.1 ± 0.9 |
| Body weight, kg | 88.2 ± 21.9 | 87.2 ± 22.4 | 86.3 ± 22.7 |
| Diabetes duration, y | 9.5 ± 7.9 | 7.3 ± 6.3 | 7.2 ± 6.0 |
| Race | |||
| White, other | 2,034 (67.7) | 971 (62.6) | 834 (53.8) |
| Asian | 779 (25.9) | 487 (31.4) | 647 (41.7) |
| Black or African American | 190 (6.3) | 93 (6.0) | 70 (4.5) |
| Renal function | |||
| Normal | 1,809 (60.2) | 1,099 (70.9) | 1,024 (66.0) |
| Mild impairment | 865 (28.8) | 415 (26.8) | 502 (32.4) |
| Moderate impairment | 329 (11.0) | 37 (2.4) | 25 (1.6) |
| Background therapy | |||
| 1–2 OADs | 1,335 (44.5) | 994 (64.1) | 1,077 (69.4) |
| Monotherapy | 703 (23.4) | 431 (27.8) | 345 (22.2) |
| Insulin | 845 (28.1) | 12 (0.8) | – |
| Diet and exercise | 120 (4.0) | 114 (7.4) | 129 (8.3) |
| Maintenance dose | |||
| Placebo | 572 (19.0) | 191 (12.3) | 129 (8.3) |
| 0.5 mg s.c. | – | – | 556 (35.8) |
| 1.0 mg s.c. | – | – | 866 (55.8) |
| 3 mg oral | 629 (20.9) | 345 (22.2) | – |
| 7 mg oral | 620 (20.6) | 331 (21.3) | – |
| 14 mg oral | 1,182 (39.4) | 684 (44.1) | – |
Data are n (%) or means ± SDs. OAD, oral antidiabetic drug; s.c., subcutaneous; SD, standard deviation.