Table 1.
Participant disposition and baseline characteristics according to combined baseline age and body mass index subgroups in the SUSTAIN Japan monotherapy trial and the SUSTAIN Japan OAD Combination trial
| SUSTAIN Japan monotherapy trial | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OW semaglutide 0.5 mg | OW semaglutide 1.0 mg | Sitagliptin | ||||||||||
| Age (year) | <65 | ≥65 | <65 | ≥65 | <65 | ≥65 | ||||||
| BMI (kg/m2) | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 |
| Participant disposition, n (%) | ||||||||||||
| Randomized | 32 | 34 | 25 | 12 | 29 | 34 | 27 | 12 | 37 | 36 | 22 | 8 |
| Trial completers | 32 (100) | 34 (100) | 25 (100) | 12 (100) | 28 (96.6) | 33 (97.1) | 26 (96.3) | 12 (100) | 36 (97.3) | 36 (100) | 21 (95.5) | 8 (100) |
| Premature treatment discontinuation | 1 (3.1) | 0 | 1 (4.0) | 1 (8.3) | 5 (17.2) | 2 (5.9) | 6 (22.2) | 2 (16.7) | 2 (5.4) | 0 | 1 (4.5) | 0 |
| Participant characteristics | ||||||||||||
| Age (years) | 53.9 (7.9) | 51.9 (8.0) | 69.5 (3.6) | 68.9 (4.0) | 54.1 (7.3) | 48.1 (8.6) | 69.9 (3.9) | 69.7 (3.6) | 55.1 (6.2) | 50.9 (7.9) | 69.2 (4.1) | 71.5 (6.1) |
| Male, n (%) | 24 (75.0) | 25 (73.5) | 20 (80.0) | 10 (83.3) | 22 (75.9) | 24 (70.6) | 19 (70.4) | 10 (83.3) | 28 (75.7) | 28 (77.8) | 18 (81.8) | 7 (87.5) |
| HbA1c (%) | 8.3 (1.0) | 8.4 (1.2) | 7.8 (0.7) | 8.6 (0.8) | 8.3 (0.8) | 8.2 (1.0) | 7.7 (0.6) | 7.5 (0.4) | 8.2 (0.9) | 8.1 (0.9) | 8.3 (1.0) | 8.3 (0.7) |
| HbA1c (mmol/mol) | 67.3 (11.3) | 68.0 (12.8) | 61.5 (8.1) | 70.0 (8.9) | 67.1 (9.1) | 66.3 (11.0) | 60.5 (6.5) | 58.7 (4.8) | 66.4 (9.5) | 65.2 (9.5) | 66.7 (11.5) | 67.6 (8.1) |
| FPG (mg/dL) | 163.6 (36.6) | 176.2 (44.1) | 155.8 (29.1) | 165.3 (30.9) | 172.7 (37.3) | 171.7 (30.4) | 156.8 (30.1) | 145.5 (20.7) | 173.8 (31.1) | 165.2 (30.0) | 173.7 (49.6) | 183.8 (37.0) |
| FPG (mmol/L) | 9.1 (2.0) | 9.8 (2.5) | 8.6 (1.6) | 9.2 (1.7) | 9.6 (2.1) | 9.5 (1.7) | 8.7 (1.7) | 8.1 (1.1) | 9.6 (1.7) | 9.2 (1.7) | 9.6 (2.8) | 10.2 (2.1) |
| Diabetes duration (years) | 9.0 (5.4) | 5.2 (4.1) | 10.6 (4.4) | 7.9 (6.1) | 8.0 (4.8) | 4.6 (3.8) | 12.1 (9.4) | 7.0 (6.6) | 7.0 (4.4) | 4.8 (3.6) | 14.3 (8.7) | 11.0 (8.0) |
| Bodyweight (kg) | 62.3 (8.1) | 78.2 (10.9) | 60.0 (7.6) | 69.2 (7.0) | 63.2 (9.7) | 85.1 (17.0) | 58.8 (7.7) | 75.8 (7.0) | 65.3 (8.9) | 80.8 (10.1) | 57.2 (7.7) | 70.8 (8.9) |
| BMI (kg/m2) | 22.6 (1.9) | 28.7 (3.4) | 22.6 (1.9) | 26.7 (2.2) | 22.7 (2.2) | 31.2 (5.0) | 22.2 (1.9) | 28.2 (1.6) | 23.3 (1.4) | 28.9 (2.7) | 21.8 (1.9) | 26.1 (1.2) |
| eGFR (mL/min/1.73 m2) | 99.2 (19.4) | 96.6 (19.6) | 97.7 (22.0) | 88.3 (14.9) | 109.0 (20.8) | 109.8 (23.6) | 92.1 (17.6) | 95.3 (18.6) | 104.1 (17.4) | 99.7 (20.2) | 86.0 (12.6) | 94.4 (17.2) |
| SUSTAIN Japan OAD Combination trial | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OW semaglutide 0.5 mg | OW semaglutide 1.0 mg | Additional OAD | ||||||||||
| Age (years) | <65 | ≥65 | <65 | ≥65 | <65 | ≥65 | ||||||
| BMI (kg/m2) | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 |
| Participant disposition, n | ||||||||||||
| Randomized | 57 | 105 | 48 | 29 | 59 | 109 | 43 | 30 | 29 | 48 | 20 | 23 |
| Trial completers | 57 (100) | 100 (95.2) | 47 (97.9) | 29 (100) | 54 (91.5) | 105 (96.3) | 42 (97.7) | 30 (100) | 29 (100) | 45 (93.8) | 20 (100) | 21 (91.3) |
| Premature treatment discontinuation | 1 (1.8) | 6 (5.7) | 6 (12.5) | 2 (6.9) | 11 (18.6) | 8 (7.3) | 14 (32.6) | 1 (3.3) | 0 | 4 (8.3) | 1 (5.0) | 2 (8.7) |
| Participant characteristics | ||||||||||||
| Age (years) | 56.5 (5.4) | 50.2 (8.2) | 70.2 (4.3) | 69.1 (3.5) | 56.3 (6.6) | 52.6 (8.5) | 70.2 (3.8) | 69.4 (3.7) | 57.7 (5.2) | 51.2 (8.4) | 70.0 (4.1) | 68.4 (3.2) |
| Male, n (%) | 41 (71.9) | 75 (71.4) | 31 (64.6) | 19 (65.5) | 47 (79.7) | 83 (76.1) | 28 (65.1) | 16 (53.3) | 24 (82.8) | 34 (70.8) | 14 (70.0) | 17 (73.9) |
| HbA1c (%) | 7.9 (0.8) | 8.3 (1.0) | 7.9 (0.8) | 7.8 (0.7) | 7.9 (0.7) | 8.4 (1.1) | 7.9 (0.7) | 8.1 (1.1) | 7.8 (0.7) | 8.3 (0.9) | 8.1 (0.8) | 8.2 (1.1) |
| HbA1c (mmol/mol) | 62.6 (9.2) | 66.8 (10.4) | 62.9 (9.0) | 61.8 (8.0) | 63.1 (7.9) | 68.1 (11.9) | 62.7 (7.4) | 64.8 (11.6) | 61.6 (8.0) | 66.9 (9.7) | 64.9 (9.0) | 65.7 (11.9) |
| FPG (mg/dL) | 158.9 (32.6) | 170.4 (36.4) | 142.4 (29.4) | 151.7 (25.1) | 155.1 (31.3) | 167.9 (40.8) | 151.8 (38.6) | 155.9 (35.4) | 160.6 (34.6) | 168.8 (36.7) | 150.8 (25.8) | 157.6 (36.5) |
| FPG (mmol/L) | 8.8 (1.8) | 9.5 (2.0) | 7.9 (1.6) | 8.4 (1.4) | 8.6 (1.7) | 9.3 (2.3) | 8.4 (2.1) | 8.7 (2.0) | 8.9 (1.9) | 9.4 (2.0) | 8.4 (1.4) | 8.7 (2.0) |
| Diabetes duration (years) | 9.0 (6.9) | 5.7 (3.7) | 10.9 (6.8) | 10.5 (6.4) | 9.9 (7.0) | 7.8 (6.0) | 11.3 (7.1) | 11.3 (4.7) | 9.2 (6.7) | 6.7 (5.4) | 14.6 (8.8) | 10.0 (6.1) |
| Bodyweight (kg) | 62.2 (7.7) | 82.0 (14.6) | 57.4 (7.5) | 70.9 (9.2) | 62.1 (7.5) | 82.4 (15.7) | 58.3 (7.8) | 71.0 (9.3) | 62.5 (7.3) | 83.3 (12.9) | 57.2 (8.1) | 74.1 (10.8) |
| BMI (kg/m2) | 22.7 (1.6) | 29.6 (4.4) | 22.0 (2.1) | 28.1 (2.3) | 22.7 (1.5) | 29.5 (4.3) | 22.2 (2.0) | 28.5 (2.9) | 22.6 (1.8) | 30.4 (3.5) | 22.1 (1.7) | 28.3 (2.3) |
| eGFR (mL/min/1.73 m2) | 104.6 (20.5) | 108.2 (20.3) | 89.1 (19.4) | 90.4 (20.1) | 100.0 (18.7) | 108.5 (27.3) | 92.9 (19.4) | 91.9 (19.2) | 100.3 (17.7) | 110.0 (25.0) | 92.5 (19.4) | 95.7 (20.6) |
All data are the mean (standard deviation) unless otherwise stated, in the full analysis set. The estimated glomerular filtration rate (eGFR) was estimated from serum creatinine using the Modification of Diet in Renal Disease formula. BMI, body mass index; FPG, fasting plasma glucose; HbA1c, glycosylated hemoglobin; n, number of participants; OAD, oral antidiabetes drug; OW, once weekly.