Semaglutide, oral in type 2 diabetes mellitus — evidence extract
The Institute's graded assessment of Semaglutide, oral for type 2 diabetes mellitus, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Type 2 diabetes mellitus
§1.1Question and anchor outcome
- Population
- A disorder of glucose regulation characterised by insulin resistance with relative insulin deficiency, diagnosed by glycated haemoglobin, fasting plasma glucose or oral glucose tolerance criteria.
- Intervention
- Semaglutide, oral, oral once daily, fasted, with no more than 120 ml of water and at least 30 minutes before other intake
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Change in HbA1c (%, mmol/mol)
Additional outcomes the Institute extracts for this indication: Proportion achieving HbA1c <7.0 % and ≤6.5 %; Change in fasting serum glucose; Change in body weight; Documented symptomatic hypoglycaemia.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Semaglutide, oral in type 2 diabetes mellitus.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| PIONEER-1 | 3 | Randomised, double-blind, placebo-controlled | 703 | 26 weeks | 2019 |
| PIONEER-6 | 3 | Event-driven cardiovascular outcome trial | 3,183 | Median 15.9 months | 2019 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: High certainty. The Institute is confident that the true effect lies close to the estimate. Further research is very unlikely to change confidence in the estimate. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Husain M, Birkenfeld AL, Donsmark M, Dungan K, Eliaschewitz FG, Franco DR, Jeppesen OK, Lingvay I, Mosenzon O, Pedersen SD, Tack CJ, Thomsen M, Vilsbøll T, Warren ML, Bain SC. Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes. New England Journal of Medicine 2019;381(9):841–851. doi:10.1056/NEJMoa1901118 · PMID 31185157
- Aroda VR, Rosenstock J, Terauchi Y, Altuntas Y, Lalic NM, Morales Villegas EC, Jeppesen OK, Christiansen E, Hertz CL, Haluzík M. PIONEER 1: randomized clinical trial of the efficacy and safety of oral semaglutide monotherapy in comparison with placebo in patients with type 2 diabetes. Diabetes Care 2019;42(9):1724–1732. doi:10.2337/dc19-0749 · PMID 31186300
- Knop FK, Aroda VR, do Vale RD, Holst-Hansen T, Laursen PN, Rosenstock J, Rubino DM, Garvey WT. Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet 2023;402(10403):705–719. doi:10.1016/S0140-6736(23)01185-6 · PMID 37364590
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.