Table 3

Supportive endpoints at week 104 for the switch part*

Treatment policy estimandTrial product estimand
Oral semaglutide (n=100)Sitagliptin (n=98)Oral semaglutide (n=100)Sitagliptin (n=98)
HbA1c <7.0% (<53 mmol/mol)
n92967670
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 value0.00480.0011
HbA1c ≤6.5% (≤48 mmol/mol)
n92967670
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 value0.00440.0015
Fasting plasma glucose
n1009810098
Estimated mean change, mmol/L−0.280.08−0.630.15
 ETD (95% CI)−0.36 (−0.97 to 0.25)−0.79 (−1.36 to −0.21)
 P value0.25200.0077
Body weight loss ≥5%
n93977972
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 value0.00240.0020
HbA1c <7.0% (<53 mmol/mol) without hypoglycemia† and without weight gain
n92967670
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 value0.00650.0006
HbA1c <7.0% (<53 mmol/mol) and without need for rescue medication‡
n9296N/AN/A
Observed proportion achieving outcome, n (%)41 (44.6)‡23 (24.0)‡N/AN/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.