Table 1. Baseline Characteristics of Patients With Type 2 Diabetes and Insufficient Glycemic Controla.
| Placebo Group (n = 71) |
Oral Semaglutide Trial Maintenance Dosage Groupsb | 1-mg SC Semaglutide Group (n = 69) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 2.5 mg (n = 70) |
Standard Dose Escalationc | Slow Escalationc | Fast Escalationc | ||||||
| 5 mg (n = 70) |
10 mg (n = 69) |
20 mg (n = 70) |
40 mg (n = 71) |
40 mg (n = 70) |
40 mg (n = 70) |
||||
| Men, No. (%) | 40 (56.3) | 45 (64.3) | 47 (67.1) | 43 (62.3) | 44 (62.9) | 43 (60.6) | 41 (58.6) | 44 (62.9) | 48 (69.6) |
| Age, mean (SD), y | 58.9 (10.3) | 56.7 (9.9) | 55.7 (11.0) | 56.5 (10.1) | 58.3 (10.4) | 56.5 (10.2) | 57.1 (10.5) | 57.7 (10.8) | 56.8 (11.8) |
| Race, No. (%) | |||||||||
| White | 57 (80.3) | 57 (81.4) | 63 (90.0) | 57 (82.6) | 59 (84.3) | 63 (88.7) | 54 (77.1) | 59 (84.3) | 54 (78.3) |
| Black or African American | 6 (8.5) | 6 (8.6) | 2 (2.9) | 7 (10.1) | 4 (5.7) | 4 (5.6) | 7 (10.0) | 7 (10.0) | 4 (5.8) |
| Asian | 7 (9.9) | 7 (10.0) | 4 (5.7) | 4 (5.8) | 4 (5.7) | 3 (4.2) | 7 (10.0) | 4 (5.7) | 10 (14.5) |
| American Indian or Alaska Native | 1 (1.4) | 0 | 0 | 0 | 2 (2.9) | 0 | 0 | 0 | 0 |
| Other | 0 | 0 | 1 (1.4) | 1 (1.4) | 1 (1.4) | 1 (1.4) | 2 (2.9) | 0 | 1 (1.4) |
| Ethnicity, No. (%) | |||||||||
| Hispanic or Latino | 9 (12.7) | 6 (8.6) | 7 (10.0) | 7 (10.1) | 7 (10.0) | 7 (9.9) | 9 (12.9) | 12 (17.1) | 7 (10.1) |
| Not Hispanic or Latino | 62 (87.3) | 64 (91.4) | 63 (90.0) | 62 (89.9) | 63 (90.0) | 64 (90.1) | 61 (87.1) | 58 (82.9) | 62 (89.9) |
| Body weight, mean (SD), kg | 93.8 (18.1) | 93.6 (15.6) | 93.1 (19.0) | 91.8 (14.0) | 93.8 (17.9) | 90.8 (16.5) | 93.3 (18.8) | 92.0 (15.4) | 88.8 (15.4) |
| BMI, mean (SD) | 32.6 (4.5) | 31.7 (4.1) | 31.6 (4.9) | 31.9 (4.4) | 32.0 (4.5) | 31.1 (4.1) | 32.3 (4.5) | 31.7 (3.8) | 30.7 (4.0) |
| HbA1c level, mean (SD), % | 8.0 (0.8) | 8.0 (0.7) | 7.8 (0.6) | 7.8 (0.7) | 7.9 (0.7) | 8.0 (0.7) | 8.0 (0.7) | 7.8 (0.8) | 7.8 (0.7) |
| FPG level, mean (SD), mg/dL | 171.7 (48.4) | 172.0 (40.2) | 172.6 (47.7) | 166.1 (36.9) | 165.1 (37.8) | 178.4 (49.1) | 172.8 (43.4) | 160.2 (30.7) | 172.8 (44.4) |
| Diabetes duration, mean (SD), y | 6.7 (5.1) | 6.1 (6.0) | 5.3 (4.7) | 5.8 (4.8) | 7.0 (5.3) | 7.7 (5.9) | 6.6 (4.9) | 5.6 (4.7) | 5.6 (5.0) |
| Metformin use, No. (%) | 58 (81.7) | 61 (87.1) | 60 (85.7) | 58 (84.1) | 59 (84.3) | 61 (85.9) | 60 (85.7) | 60 (85.7) | 58 (84.1) |
| SBP, mean (SD), mm Hg | 135.4 (15.5) | 132.3 (13.3) | 132.9 (13.8) | 134.1 (14.1) | 136.5 (15.8) | 134.0 (15.3) | 131.3 (14.6) | 135.0 (16.9) | 134.2 (14.5) |
| DBP, mean (SD), mm Hg | 80.6 (8.4) | 80.5 (8.0) | 81.5 (10.2) | 81.6 (10.0) | 80.7 (8.2) | 82.4 (8.4) | 82.4 (7.8) | 79.2 (9.1) | 80.9 (8.9) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); DBP, diastolic blood pressure; FPG, fasting plasma glucose; HbA1c, hemoglobin A1c; SBP, systolic blood pressure; SC, subcutaneous.
SI conversion factor: To convert glucose to mmol/L, multiply by 0.0555.
a
Full analysis set.
b
See Figure 1 for dosage regimen.
c
Standard escalation indicates 4-week intervals; slow escalation, 8-week intervals; fast escalation, 2-week intervals.