Table 2

Secondary end points at week 26

Treatment policy estimandTrial product estimand
Oral semaglutide 3 mg (n = 175)Oral semaglutide 7 mg (n = 175)Oral semaglutide 14 mg (n = 175)Placebo (n = 178)Oral semaglutide 3 mg (n = 175)Oral semaglutide 7 mg (n = 175)Oral semaglutide 14 mg (n = 175)Placebo (n = 178)
% achieving HbA1c <7% (53 mmol/mol)55.168.876.931.059.171.980.333.8
 OR (95% CI) vs. placebo3.09 (1.91–4.99)5.79 (3.50–9.59)8.36 (4.86–14.41)3.37 (2.05–5.55)8.65 (5.04–14.83)13.35 (7.49–23.83)
 P value<0.001<0.001<0.001<0.001<0.001<0.001
% achieving HbA1c ≤6.5% (48 mmol/mol)35.947.563.817.938.950.068.021.1
 OR (95% CI) vs. placebo2.83 (1.66–4.83)5.10 (2.97–8.76)9.06 (5.20–15.78)2.86 (1.65–4.96)6.30 (3.60–11.02)12.06 (6.75–21.55)
 P value<0.001<0.001<0.001<0.001<0.001<0.001
% achieving body weight loss ≥5%19.626.941.314.921.328.744.315.7
 OR (95% CI) vs. placebo1.30 (0.73–2.33)2.05 (1.16–3.63)3.74 (2.18–6.41)1.27 (0.70–2.31)1.92 (1.08–3.42)4.17 (2.38–7.29)
 P value0.370.01<0.0010.430.03<0.001
% achieving composite: HbA1c <7% (53 mmol/mol) without hypoglycemia* and no weight gain37.156.968.823.241.659.672.827.1
 OR (95% CI) vs. placebo1.98 (1.21–3.24)4.49 (2.74–7.36)7.13 (4.28–11.89)2.20 (1.33–3.64)5.29 (3.17–8.83)10.08 (5.87–17.32)
 P value0.007<0.001<0.0010.002<0.001<0.001
% achieving composite: HbA1c reduction ≥1% (11 mmol/mol) and body weight loss ≥3%18.036.950.610.720.139.054.411.3
 OR (95% CI) vs. placebo1.71 (0.90–3.26)4.51 (2.47–8.22)7.96 (4.40–14.42)2.11 (1.07–4.13)5.90 (3.12–11.17)11.66 (6.15–22.11)
 P value0.10<0.001<0.0010.03<0.001<0.001
Fasting plasma glucose, mg/dL
 Estimated mean143.4131.7126.7156.3147.0132.6122.8163.5
 Mean change from baseline−16.2−27.9−32.9−3.2−12.5−27.0−36.74.0
 Estimated treatment difference vs. placebo (95% CI)−12.9 (–21.4 to –4.5)−24.6 (–35.1 to –14.2)−29.6 (–38.3 to –21.0)−16.5 (–24.2 to –8.8)−30.9 (–38.7 to –23.2)−40.7 (–48.5 to –33.0)
 P value0.003<0.001<0.001<0.001<0.001<0.001
7-point SMBG mean, mg/dL
 Estimated mean153.2147.8143.2175.9148.8141.9138.4174.5
 Mean change from baseline−30.1−35.5−40.1−7.5−30.9−37.8−41.3−5.2
 Estimated treatment difference vs. placebo (95% CI)−22.7 (–31.0 to –14.4)−28.1 (–37.4 to –18.7)−32.6 (–41.8 to –23.5)−25.7 (–33.5 to –17.9)−32.6 (–40.4 to –24.8)−36.1 (–43.9 to –28.3)
 P value<0.001<0.001<0.001<0.001<0.001<0.001
  • SI conversion factor: to convert glucose from mg/dL to mmol/L, multiply by 0.055494. The mean ± SD for the 7-point SMBG at baseline was 183.3 ± 42.2 mg/dL. Treatment policy estimand: ANCOVA for continuous end points and logistic regression for binary end points, using data irrespective of discontinuation of trial product and initiation of rescue medication. Missing values were imputed by a pattern mixture model using multiple imputation. Patterns were defined by use of trial product and rescue medication. Trial product estimand: MMRM for continuous end points and logistic regression for binary end points. Data collected after discontinuation of trial product and initiation of rescue medication were excluded. For binary end points, missing values were imputed from subjects randomized to the same trial product using sequential multiple imputation. P values less than 0.001 are reported as P < 0.001. P values between 0.001 and 0.01 are reported to the nearest thousandth, and P values greater than or equal to 0.01 are reported to the nearest hundredth. % achieving, proportion of patients achieving; OR, odds ratio.

  • *Severe or blood glucose–confirmed (<56 mg/dL) symptomatic hypoglycemic episode.