Table 2. Hemoglobin A1c (HbA1c), Fasting Plasma Glucose, and Body Weight From Baseline to Week 26 Among Patients With Type 2 Diabetes and Insufficient Glycemic Controla.
| Placebo Group (n = 71) |
Oral Semaglutide Groups | 1-mg SC Semaglutide Group (n = 69) |
|||||
|---|---|---|---|---|---|---|---|
| 2.5 mg (n = 70) |
Standard Dose Escalationb | ||||||
| 5 mg (n = 70) |
10 mg (n = 69) |
20 mg (n = 70) |
40 mg (n = 71) |
||||
| Primary Analysis | |||||||
| HbA1c level at week 26, mean (95% CI), % | 7.6 (7.4 to 7.8) |
7.2 (7.0 to 7.4) |
6.7 (6.5 to 6.9) |
6.4 (6.2 to 6.6) |
6.2 (6.0 to 6.4) |
6.0 (5.8 to 6.2) |
6.0 (5.8 to 6.2) |
| Change from baseline in HbA1c level to week 26, mean (95% CI), % | –0.3 (–0.5 to –0.1) |
–0.7 (–0.9 to –0.5) |
–1.2 (–1.4 to –1.0) |
–1.5 (–1.7 to –1.3) |
–1.7 (–1.9 to –1.5) |
–1.9 (–2.1 to –1.7) |
–1.9 (–2.1 to –1.7) |
| ETD for comparator vs placebo for HbA1c level (95% CI), % | NA | –0.4 (–0.7 to –0.1) |
–0.9 (–1.2 to –0.6) |
–1.2 (–1.5 to –0.9) |
–1.4 (–1.7 to –1.0) |
–1.6 (–1.9 to –1.3) |
–1.6 (–1.8 to –1.3) |
| P value | NA | <.01 | <.001 | <.001 | <.001 | <.001 | <.001 |
| Secondary Analyses | |||||||
| ETD for comparator vs SC semaglutide for HbA1c level (95% CI), % | NA | 1.2 (0.9 to 1.4) |
0.7 (0.4 to 1.0) |
0.4 (0.1 to 0.7) |
0.2 (–0.1 to 0.5) |
<–0.0 (–0.3 to 0.3) |
NA |
| P value | NA | <.001 | <.001 | .01 | .24 | .80 | NA |
| Change from baseline in fasting plasma glucose to week 26, mean (95% CI), mg/dL | –1.1 (–9.6 to –7.5) |
–17.3 (–25.6 to –9.1) |
–27.8 (–36.1 to –19.4) |
–42.1 (–50.4 to –33.9) |
–41.9 (–50.6 to –33.1) |
–51.2 (–60.0 to –42.4) |
–56.3 (–65.3 to –47.4) |
| ETD for comparator vs placebo for fasting plasma glucose (95% CI), mg/dL | NA | –16.3 (–28.2 to –4.3) |
–26.7 (–38.7 to –14.6) |
–41.0 (–52.8 to –29.2) |
–40.8 (–52.9 to –28.6) |
–50.1 (–62.4 to –37.8) |
–55.3 (–67.6 to –42.9) |
| P value | NA | <.01 | <.001 | <.001 | <.001 | <.001 | <.001 |
| Change from baseline in body weight to week 26, mean (95% CI), kg | –1.2 (–2.3 to –0.1) |
–2.1 (–3.1 to –1.0) |
–2.7 (–3.7 to –1.6) |
–4.8 (–5.8 to –3.7) |
–6.1 (–7.3 to –5.0) |
–6.9 (–8.0 to –5.8) |
–6.4 (–7.5 to –5.3) |
| ETD for comparator vs placebo for body weight (95% CI), kg | NA | –0.9 (–2.4 to 0.6) |
–1.5 (–3.0 to 0.0) |
–3.6 (–5.1 to –2.1) |
–5.0 (–6.5 to –3.4) |
–5.7 (–7.3 to –4.2) |
–5.2 (–6.8 to –3.7) |
| P value | NA | .25 | .06 | <.001 | <.001 | <.001 | <.001 |
Abbreviations: ETD, estimated treatment difference; NA, not applicable; SC, subcutaneous.
SI conversion factor: To convert glucose to mmol/L, multiply by 0.0555.
a
Data are estimated means from repeated measures model analysis with treatment, stratum, and country as fixed factors and baseline value as covariate, all nested within visit.
b
Standard escalation indicates 4-week intervals.