Supportive endpoints at week 104 for the switch part*
| Treatment policy estimand | Trial product estimand | |||
| Oral semaglutide (n=100) | Sitagliptin (n=98) | Oral semaglutide (n=100) | Sitagliptin (n=98) | |
| HbA1c <7.0% (<53 mmol/mol) | ||||
| n | 92 | 96 | 76 | 70 |
| Observed proportion achieving outcome, n (%) | 44 (47.8) | 26 (27.1) | 40 (52.6) | 20 (28.6) |
| EOR (95% CI) | 2.65 (1.35 to 5.22) | 3.97 (1.73 to 9.07) | ||
| P value | 0.0048 | 0.0011 | ||
| HbA1c ≤6.5% (≤48 mmol/mol) | ||||
| n | 92 | 96 | 76 | 70 |
| Observed proportion achieving outcome, n (%) | 28 (30.4) | 11 (11.5) | 28 (36.8) | 10 (14.3) |
| EOR (95% CI) | 3.41 (1.47 to 7.92) | 4.19 (1.73 to 10.15) | ||
| P value | 0.0044 | 0.0015 | ||
| Fasting plasma glucose | ||||
| n | 100 | 98 | 100 | 98 |
| Estimated mean change, mmol/L | −0.28 | 0.08 | −0.63 | 0.15 |
| ETD (95% CI) | −0.36 (−0.97 to 0.25) | −0.79 (−1.36 to −0.21) | ||
| P value | 0.2520 | 0.0077 | ||
| Body weight loss ≥5% | ||||
| n | 93 | 97 | 79 | 72 |
| Observed proportion achieving outcome, n (%) | 31 (33.3) | 12 (12.4) | 30 (38.0) | 7 (9.7) |
| EOR (95% CI) | 3.20 (1.51 to 6.78) | 3.65 (1.60 to 8.33) | ||
| P value | 0.0024 | 0.0020 | ||
| HbA1c <7.0% (<53 mmol/mol) without hypoglycemia† and without weight gain | ||||
| n | 92 | 96 | 76 | 70 |
| Observed proportion achieving outcome, n (%) | 36 (39.1) | 18 (18.8) | 33 (43.4) | 13 (18.6) |
| EOR (95% CI) | 2.66 (1.32 to 5.39) | 4.14 (1.84 to 9.29) | ||
| P value | 0.0065 | 0.0006 | ||
| HbA1c <7.0% (<53 mmol/mol) and without need for rescue medication‡ | ||||
| n | 92 | 96 | N/A | N/A |
| Observed proportion achieving outcome, n (%) | 41 (44.6)‡ | 23 (24.0)‡ | N/A | N/A |
Proportions are observed proportions of patients with non-missing information.
*Patients previously randomized to sitagliptin at baseline (week 0) and rerandomized to either oral semaglutide or sitagliptin at the start of the extension phase (week 52). Covers the period between week 52 and week 104.
†Treatment-emergent severe or confirmed by blood glucose concentration <3.1 mmol/L (<56 mg/dL) symptomatic hypoglycemia.
‡Measured during the in-trial period (the period during which patients were considered in the trial). As it was not analyzed statistically, the use of an estimand did not apply.
EOR, estimated OR; ETD, estimated treatment difference; HbA1c, glycated hemoglobin; n, number of patients contributing to the analyses; N/A, not applicable.