Oral peptide GLP-1 receptor agonist
Semaglutide 7 mg oral once daily (original tablet)
SEMA_PO_7MG_QD
A prespecified sensitivity analysis pools 3 mg with reformulated 1.5 mg; 7 mg with 4 mg; and 14 mg with 9 mg only.
Related
- All doses pooled: Semaglutide tablet
- Semaglutide 14 mg oral once daily (original tablet)
- Semaglutide 20 mg tablet once daily
- Semaglutide 40 mg tablet once daily
- Semaglutide 3 mg oral once daily (original tablet)
- Semaglutide oral once daily (original tablet), flexible dose: 3, 7 or 14 mg adjusted by HbA1c and tolerability
- Semaglutide 50 mg oral once daily (higher dose oral program)
Effects across outcomes
Bayesian random effects estimate against the comparator of each analysis (usually placebo), posterior median and 95% credible interval. Green: clearly better; red: clearly worse.
| Condition | Outcome | Window | Versus | Effect (95% CrI) | SUCRA |
|---|---|---|---|---|---|
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -0.98 (-1.24 to -0.69) | 0.53 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -0.78 (-1.27 to -0.27) | 0.42 |
| Type 2 diabetes (adults) | HbA1c change | weeks 36 to 64 (target week 52) | Placebo | MD -0.98 (-1.29 to -0.57) | 0.38 |
| Type 2 diabetes (adults) | HbA1c change | weeks 36 to 64 (target week 52) | Placebo | MD -0.85 (-1.30 to -0.23) | 0.70 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -0.80 (-1.16 to -0.43) | 0.55 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -3.04 (-4.96 to -1.17) | 0.93 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -1.27 (-1.47 to -1.08) | 0.78 |
| Type 2 diabetes (adults) | HbA1c change | weeks 36 to 64 (target week 52) | Placebo | MD -1.36 (-2.11 to -0.15) | 0.73 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -2.25 (-3.09 to -1.41) | 0.62 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 36 to 64 (target week 52) | Placebo | MD -2.46 (-4.27 to -0.39) | 0.72 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 36 to 64 (target week 52) | Placebo | MD -2.24 (-5.18 to 1.32) | 0.49 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -0.22 (-3.99 to 4.35) | 0.45 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -2.46 (-3.42 to -1.37) | 0.71 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 36 to 64 (target week 52) | Placebo | MD 0.23 (-3.92 to 4.60) | 0.55 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -1.14 (-2.21 to -0.14) | 0.80 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -1.19 (-4.03 to 2.14) | 0.62 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 20 to 36 (target week 26) | Placebo | OR 6.76 (1.75 to 16.49) | 0.52 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 36 to 64 (target week 52) | Placebo | OR 3.92 (0.67 to 12.83) | 0.61 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 36 to 64 (target week 52) | Placebo | OR 3.75 (1.08 to 8.46) | 0.55 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 20 to 36 (target week 26) | Placebo | OR 6.24 (2.32 to 14.35) | 0.65 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 20 to 36 (target week 26) | Placebo | OR 8.73 (2.76 to 24.91) | 0.59 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 36 to 64 (target week 52) | Placebo | OR 8.60 (1.55 to 30.22) | 0.81 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.23 (0.00 to 8.72) | 0.58 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 1.19 (0.39 to 3.52) | 0.56 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.88 (0.42 to 1.87) | 0.52 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD -3.11 (-5.08 to -1.11) | 0.64 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 36 to 64 (target week 52) | Placebo | MD -1.00 (-3.76 to 1.94) | 0.80 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 36 to 64 (target week 52) | Placebo | MD -1.44 (-4.82 to 2.14) | 0.37 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 36 to 64 (target week 52) | Placebo | MD -3.45 (-9.41 to 3.71) | 0.65 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD -0.13 (-2.92 to 2.59) | 0.56 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 40 to 104 (target week 68) | Semaglutide 14 mg oral once daily (original tablet) | MD 1.61 (-5.19 to 8.69) | 0.24 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 40 to 104 (target week 68) | Placebo | MD -3.14 (-5.79 to -0.02) | 0.75 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -2.97 (-5.04 to -0.53) | 0.76 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -1.99 (-9.86 to 6.14) | 0.50 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -1.94 (-8.26 to 5.26) | 0.56 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -0.81 (-2.58 to 1.10) | 0.69 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 4.85 (1.45 to 13.31) | 0.56 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 3.70 (0.89 to 12.65) | 0.76 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 3.95 (1.30 to 10.19) | 0.74 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 3.46 (1.14 to 8.75) | 0.74 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 2.02 (0.79 to 4.68) | 0.72 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 6.35 (1.30 to 30.38) | 0.64 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 7.15 (1.28 to 39.47) | 0.91 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 6.77 (1.65 to 28.80) | 0.79 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 4.93 (1.41 to 16.45) | 0.90 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 4.78 (1.13 to 20.59) | 0.72 |
| Type 2 diabetes (adults) | SF-36 physical component summary change | weeks 20 to 130 (target week 52) | Placebo | MD -0.20 (-0.92 to 0.56) | 0.34 |
| Type 2 diabetes (adults) | SF-36 physical component summary change | weeks 20 to 130 (target week 52) | Placebo | MD 0.49 (-0.75 to 1.78) | 0.38 |
| Type 2 diabetes (adults) | SF-36 physical component summary change | weeks 20 to 130 (target week 52) | Semaglutide 3 mg oral once daily (original tablet) | MD 0.05 (-7.75 to 7.55) | 0.50 |
| Type 2 diabetes (adults) | Serious adverse events | longest follow-up | Placebo | HR 0.90 (0.69 to 1.19) | 0.54 |
| Type 2 diabetes (adults) | Discontinuation due to adverse events | longest follow-up | Placebo | HR 1.02 (0.62 to 1.67) | 0.66 |
| Type 2 diabetes (adults) | Nausea | longest follow-up | Placebo | HR 2.08 (1.55 to 2.75) | 0.60 |
| Type 2 diabetes (adults) | Vomiting | longest follow-up | Placebo | HR 2.43 (1.63 to 3.53) | 0.54 |
| Type 2 diabetes (adults) | Diarrhea | longest follow-up | Placebo | HR 1.40 (1.07 to 1.84) | 0.57 |
| Type 2 diabetes (adults) | Constipation | longest follow-up | Placebo | HR 2.18 (1.48 to 3.26) | 0.38 |
| Type 2 diabetes (adults) | Discontinuation due to gastrointestinal adverse events | longest follow-up | Placebo | HR 2.74 (0.50 to 12.91) | 0.41 |
| Type 2 diabetes (adults) | Gallbladder and biliary disease | longest follow-up | Placebo | HR 0.71 (0.04 to 14.75) | 0.57 |
| Type 2 diabetes (adults) | Acute pancreatitis | longest follow-up | Placebo | HR 0.62 (0.04 to 8.51) | 0.54 |
| Type 2 diabetes (adults) | Diabetic retinopathy complications | longest follow-up | Placebo | HR 1.73 (0.42 to 7.33) | 0.36 |
| Type 2 diabetes (adults) | Any cancer | longest follow-up | Placebo | HR 1.09 (0.06 to 16.91) | 0.52 |
| Type 2 diabetes (adults) | Acute kidney injury | longest follow-up | Placebo | HR 0.39 (0.02 to 4.14) | 0.61 |
Trials
- ACHIEVE-3A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-3)2023 · 1,698 randomized · 52 weeks
- S0030362022 · 58 randomized · 24 weeks
- PIONEER 11China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only2019 · 521 randomized · 26 weeks
- PIONEER 12China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin2019 · 1,441 randomized · 26 weeks
- PIONEER 10Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese Subjects With Type 2 Diabetes2017 · 458 randomized · 52 weeks
- PIONEER 9Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes2017 · 243 randomized · 52 weeks
- PIONEER 8Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)2017 · 731 randomized · 52 weeks
- PIONEER 3Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes2016 · 1,864 randomized · 78 weeks
- PIONEER 1Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only.2016 · 703 randomized · 26 weeks