Table 1

Baseline demographics and disease characteristics

Durability
(baseline: week 0)*
Switch
(baseline: week 52)†
Oral semaglutide
(n=253)
Oral semaglutide
(n=100)
Sitagliptin
(n=98)
Age, years57 (10)58 (10)‡58 (10)‡
Female, n (%)108 (42.7)43 (43.0)‡43 (43.9)‡
Race, n (%)
White195 (77.1)77 (77.0)‡71 (72.4)‡
Black or African American22 (8.7)6 (6.0)‡10 (10.2)‡
Asian34 (13.4)17 (17.0)‡17 (17.3)‡
Other§2 (0.8)0‡0‡
Ethnicity, n (%)
Hispanic or Latino48 (19.0)16 (16.0)‡19 (19.4)‡
Not Hispanic or Latino205 (81.0)84 (84.0)‡79 (80.6)‡
HbA1c
Mean, %8.3 (0.6)7.4 (1.0)7.5 (0.9)
≤7.5, n (%)19 (7.5)64 (64.0)59 (60.2)
>7.5–≤8.5, n (%)157 (62.1)31 (31.0)25 (25.5)
>8.5, n (%)77 (30.4)5 (5.0)14 (14.3)
HbA1c, mmol/mol67.0 (6.3)57.1 (10.9)58.4 (10.0)
Duration of diabetes, years8.6 (6.3)8.1 (5.4)‡9.6 (6.4)‡
Fasting plasma glucose, mmol/L9.8 (2.4)8.1 (1.9)8.3 (2.1)
Body weight, kg88.9 (19.6)85.8 (15.4)86.9 (20.4)
Body mass index, kg/m231.5 (6.5)31.0 (5.4)30.6 (5.9)
eGFR,¶ geometric mean (CV), mL/min/1.73 m295.9 (15.8)91.9 (17.4)92.9 (19.1)
Background medication at baseline, n (%)**
Patients receiving one type of concomitant glucose-lowering medication106 (41.9)30 (30.0)41 (41.8)
Metformin102 (40.3)29 (29.0)36 (36.7)
Sulfonylurea3 (1.2)03 (3.1)
SGLT-2 inhibitor1 (0.4)1 (1.0)2 (2.0)
Thiazolidinedione000
Patients receiving two types of concomitant glucose-lowering medication146 (57.7)63 (63.0)52 (53.1)
Metformin+sulfonylurea119 (47.0)45 (45.0)40 (40.8)
Metformin+SGLT-2 inhibitor16 (6.3)15 (15.0)9 (9.2)
Metformin+thiazolidinedione9 (3.6)1 (1.0)1 (1.0)
Metformin+insulin002 (2.0)
Metformin+other1 (0.4)00
Sulfonylurea+SGLT-2 inhibitor1 (0.4)00
Sulfonylurea+thiazolidinedione01 (1.0)0
Sulfonylurea+insulin01 (1.0)0
Patients receiving three types of concomitant glucose-lowering medication1 (0.4)7 (7.0)5 (5.1)
Metformin+SGLT-2 inhibitor+sulfonylurea1 (0.4)5 (5.0)4 (4.1)
Metformin+SGLT-2 inhibitor+insulin001 (1.0)
Metformin+sulfonylurea+insulin01 (1.0)0
Metformin+sulfonylurea+thiazolidinedione01 (1.0)0
  • Data are mean (SD) unless otherwise indicated.

  • *Patients randomized to oral semaglutide at baseline (week 0). Baseline data were obtained at week 0.

  • †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). Baseline data were obtained at the latest assessment at, or prior to, week 52, unless otherwise indicated.

  • ‡Measured at the start of the main phase (week 0).

  • §Includes American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, and other.

  • ¶Estimated using the Chronic Kidney Disease Epidemiology Collaboration formula.

  • **Prescribed rescue medication in the main phase was treated as background medication in the extension phase.

  • CV, coefficient of variation; eGFR, estimated glomerular filtration rate; HbA1c, glycated hemoglobin; SGLT-2, sodium glucose co-transporter 2.