Oral peptide GLP-1 receptor agonist
Semaglutide 3 mg oral once daily (original tablet)
SEMA_PO_3MG_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 7 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 -0.41 (-0.68 to -0.15) | 0.14 |
| Type 2 diabetes (adults) | HbA1c change | weeks 36 to 64 (target week 52) | Placebo | MD -0.25 (-0.64 to 0.20) | 0.07 |
| Type 2 diabetes (adults) | HbA1c change | weeks 36 to 64 (target week 52) | Placebo | MD -0.42 (-0.86 to 0.19) | 0.30 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -0.28 (-0.64 to 0.09) | 0.12 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -1.22 (-3.30 to 0.84) | 0.53 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -0.80 (-1.00 to -0.60) | 0.35 |
| Type 2 diabetes (adults) | HbA1c change | weeks 36 to 64 (target week 52) | Placebo | MD -0.98 (-1.76 to 0.26) | 0.45 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -1.05 (-1.92 to -0.22) | 0.38 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 36 to 64 (target week 52) | Placebo | MD -1.56 (-3.36 to 0.49) | 0.46 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 36 to 64 (target week 52) | Placebo | MD -1.27 (-4.79 to 2.60) | 0.37 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD 0.60 (-3.10 to 5.16) | 0.34 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -1.54 (-2.51 to -0.48) | 0.45 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 36 to 64 (target week 52) | Placebo | MD 1.03 (-2.92 to 5.44) | 0.41 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -0.09 (-1.13 to 0.87) | 0.43 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -0.10 (-2.20 to 2.24) | 0.25 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 20 to 36 (target week 26) | Placebo | OR 2.18 (0.61 to 5.36) | 0.20 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 36 to 64 (target week 52) | Placebo | OR 1.38 (0.24 to 4.69) | 0.17 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 36 to 64 (target week 52) | Placebo | OR 1.76 (0.51 to 3.94) | 0.16 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 20 to 36 (target week 26) | Placebo | OR 2.46 (0.90 to 5.65) | 0.23 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 20 to 36 (target week 26) | Placebo | OR 4.53 (1.41 to 12.75) | 0.31 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 36 to 64 (target week 52) | Placebo | OR 3.80 (0.71 to 13.36) | 0.46 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.23 (0.00 to 8.94) | 0.58 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.61 (0.19 to 1.93) | 0.76 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 1.17 (0.57 to 2.45) | 0.43 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD -0.61 (-2.27 to 1.08) | 0.29 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 36 to 64 (target week 52) | Placebo | MD 0.61 (-2.07 to 3.49) | 0.67 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 36 to 64 (target week 52) | Placebo | MD -2.14 (-8.51 to 4.79) | 0.40 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD 0.92 (-1.76 to 3.80) | 0.27 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 40 to 104 (target week 68) | Placebo | MD -1.97 (-4.56 to 1.07) | 0.48 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -1.91 (-3.95 to 0.42) | 0.49 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD 0.00 (-7.83 to 7.75) | 0.28 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD 0.04 (-6.26 to 7.05) | 0.25 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD 0.27 (-1.51 to 2.06) | 0.32 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 1.65 (0.43 to 4.48) | 0.26 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 0.86 (0.18 to 3.58) | 0.17 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 1.74 (0.52 to 4.40) | 0.42 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 1.88 (0.55 to 4.59) | 0.42 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 1.15 (0.41 to 2.59) | 0.42 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 0.96 (0.16 to 5.19) | 0.20 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 0.14 (0.00 to 2.31) | 0.12 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 1.14 (0.24 to 5.17) | 0.23 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 0.94 (0.22 to 3.30) | 0.25 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 1.31 (0.23 to 6.71) | 0.35 |
| Type 2 diabetes (adults) | SF-36 physical component summary change | weeks 20 to 130 (target week 52) | Placebo | MD -0.55 (-1.43 to 0.31) | 0.14 |
| Type 2 diabetes (adults) | SF-36 physical component summary change | weeks 20 to 130 (target week 52) | Placebo | MD 0.49 (-0.75 to 1.83) | 0.39 |
| Type 2 diabetes (adults) | Serious adverse events | longest follow-up | Placebo | HR 1.24 (0.95 to 1.62) | 0.35 |
| Type 2 diabetes (adults) | Discontinuation due to adverse events | longest follow-up | Placebo | HR 0.94 (0.56 to 1.58) | 0.68 |
| Type 2 diabetes (adults) | Nausea | longest follow-up | Placebo | HR 1.57 (1.13 to 2.17) | 0.69 |
| Type 2 diabetes (adults) | Vomiting | longest follow-up | Placebo | HR 1.64 (1.01 to 2.60) | 0.65 |
| Type 2 diabetes (adults) | Diarrhea | longest follow-up | Placebo | HR 1.27 (0.94 to 1.74) | 0.61 |
| Type 2 diabetes (adults) | Constipation | longest follow-up | Placebo | HR 1.32 (0.77 to 2.18) | 0.59 |
| Type 2 diabetes (adults) | Discontinuation due to gastrointestinal adverse events | longest follow-up | Placebo | HR 1.26 (0.17 to 7.04) | 0.58 |
| Type 2 diabetes (adults) | Gallbladder and biliary disease | longest follow-up | Placebo | HR 1.58 (0.10 to 27.92) | 0.41 |
| Type 2 diabetes (adults) | Acute pancreatitis | longest follow-up | Placebo | HR 0.62 (0.04 to 8.10) | 0.54 |
| Type 2 diabetes (adults) | Diabetic retinopathy complications | longest follow-up | Placebo | HR 1.77 (0.44 to 7.55) | 0.35 |
| Type 2 diabetes (adults) | Any cancer | longest follow-up | Placebo | HR 1.12 (0.06 to 16.52) | 0.52 |
| Type 2 diabetes (adults) | Acute kidney injury | longest follow-up | Placebo | HR 0.38 (0.03 to 4.21) | 0.61 |
Trials
- 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 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
- PIONEER 3Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes2016 · 1,864 randomized · 78 weeks