Table 1.
Patient demographics and baseline characteristics in the focus groups, cognitive debriefing interviews, and Phase IIa and IIb trials
| Patient characteristics | Focus groups (N=21) | Cognitive debriefing interviews (N=20) | Phase IIa (N=119)b | Phase IIb (N=392) |
|---|---|---|---|---|
|
| ||||
| Mean age, years (SD) | 52.8 (12.6) | 52.1 (11.3) | 54.5 (10.4) | 57.0 (11.3) |
| Median (min, max) | 56.0 (27, 67) | 53.5 (31, 69) | 54.0 (27, 75) | 58.2 (20, 76) |
| Female, n (%) | 17 (81.0) | 14 (70.0) | 83 (69.7) | 244 (62.2) |
| Race, n (%)a | ||||
| White | 17 (81.0) | 14 (70.0) | 92 (77.3) | 310 (79.1) |
| Black or African American | 3 (14.3) | 6 (30.0) | 24 (20.2) | 65 (16.6) |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 0 (0.0) | 0 (0.0) | 45 (37.8) | 188 (48.0) |
| Mean BMI, kg/m2 (SD) | 31.7 (7.6) | 31.1 (7.0) | 32.0 (6.8) | 32.4 (7.3) |
| Median (min, max) | 31.6 (19, 47) | 30.9 (20, 41) | 31.0 (21, 51) | 31.4 (18, 60) |
| Diabetes type, n (%) | ||||
| Type 1 | 9 (42.9) | 8 (40.0) | 13 (10.9) | 39 (9.9) |
| Type 2 | 12 (57.1) | 12 (60.0) | 106 (89.1) | 350 (89.3) |
| Types 1 and 2 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (0.8) |
Notes:
a
One focus group participant was mixed race;
b
the Phase IIa psychometric analysis population comprised participants with vomiting severity score >0 at baseline.
Abbreviations: BMI, body mass index.