Table 1.
Baseline characteristics and demographics and change from baseline (modified intention-to-treat population*)
| Parameter | Overall | Europe† | Brazil | ||||||
| DMR N=56 | Sham N=52 | P value | DMR N=39 | Sham N=36 |
P value | DMR N=17 | Sham N=16 | P value | |
| Age, years | 58.0 (13.5) | 58.5 (14.0) | 0.747 | 59.0 (13.0) | 56.5 (14.0) | 0.627 | 56.0 (13.0) | 59.5 (11.5) | 0.164 |
| Sex, n (%) | 0.963 | 0.93 | 0.866 | ||||||
| Female | 17 (30.4) | 16 (30.8) | 9 (23.1) | 8 (22.2) | 8 (41.7) | 8 (50.0) | |||
| Male | 39 (69.6) | 36 (69.2) | 30 (76.9) | 28 (77.8) | 9 (52.7) | 8 (50.0) | |||
| Race, n (%) | 0.974 | 0.658 | 0.562 | ||||||
| White | 37 (66.1) | 34 (65.4) | 25 (64.1) | 21 (58.3) | 12 (70.6) | 13 (81.3) | |||
| Black | 4 (7.1) | 3 (5.8) | 0 | 0 | 4 (23.5) | 3 (18.8) | |||
| Asian | 1 (1.8) | 1 (1.9) | 0 | 1 (2.8) | 1 (5.9) | 0 | |||
| Other | 1 (1.8) | 2 (3.8) | 1 (2.6) | 2 (5.6) | 0 | 0 | |||
| Undisclosed | 13 (23.2) | 12 (23.1) | 13 (33.3) | 12 (33.3) | 0 | 0 | |||
| Weight, kg | |||||||||
| Baseline | 93.0 (15.9) | 92.6 (26.4) | 0.438 | 93.1 (16.5) | 94.5 (24.6) | 0.644 | 89.0 (15.6) | 87.8 (19.8) | 0.627 |
| Week 24 | 90.0 (17.5) | 87.4 (26.0) | 0.707 | 91.0 (17.5) | 92.6 (27.0) | 0.937 | 86.8 (19.7) | 83.2 (22.6) | 0.678 |
| Change from baseline (week 24) | |||||||||
| Absolute | −2.5 (4.5) | −1.5 (3.3) | 0.021 | −2.4 (2.8) | −1.4 (2.4) | 0.012 | −4.1 (5.6) | −2.1 (5.7) | 0.285 |
| Relative (%) | −2.8 (4.5) | −1.8 (3.5) | 0.037 | −2.6 (3.4) | −1.5 (2.9) | 0.013 | −4.5 (5.7) | −2.8 (5.6) | 0.403 |
| BMI, kg/m2 | |||||||||
| Baseline | 31.5 (4.7) | 30.7 (5.7) | 0.206 | 31.4 (4.5) | 30.4 (6.1) | 0.16 | 32.3 (4.7) | 31.6 (6.2) | 0.928 |
| Week 24 | 30.6 (5.2) | 29.9 (5.5) | 0.563 | 30.6 (5.0) | 29.7 (6.3) | 0.376 | 30.6 (5.6) | 30.8 (5.9) | 0.828 |
| Change from baseline (week 24) | |||||||||
| Absolute | −0.9 (1.5) | −0.5 (1.1) | 0.025 | −0.8 (1.2) | −0.5 (0.9) | 0.011 | −1.4 (1.9) | −0.8 (1.9) | 0.28 |
| Relative (%) | −2.8 (4.5) | −1.8 (3.5) | 0.042 | −2.6 (3.4) | −1.5 (2.9) | 0.013 | −4.5 (5.7) | −2.8 (5.6) | 0.365 |
| HbA1c levels, mmol/mol | |||||||||
| Baseline | 65.6 (8.7) | 66.1 (10.4) | 0.839 | 65.0 (7.6) | 66.1 (9.3) | 0.45 | 70.5 (9.8) | 65.6 (14.2) | 0.213 |
| Week 24 | 55.2 (16.4) | 61.2 (18.0) | 0.436 | 59.6 (16.4) | 63.9 (14.2) | 0.132 | 51.9 (5.5) | 48.6 (8.7) | 0.104 |
| Change from baseline (week 24) | |||||||||
| Absolute | −10.4 (18.6) | −7.1 (16.4) | 0.147 | −6.6 (17.5) | −3.3 (10.9) | 0.033 | −20.2 (14.2) | −17.5 (9.8) | 0.104 |
| Relative (%) | −16.7 (28.6) | −10.6 (23.3) | 0.184 | −9.6 (27.1) | −3.8 (18.3) | 0.034 | −27.6 (14.9) | −25.6 (12.9) | 0.105 |
DMR, duodenal mucosal resurfacing; HbA1c, haemoglobin A1c.