2019
DOI: 10.1016/s2213-8587(19)30194-9
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Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial

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Cited by 194 publications
(330 citation statements)
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“…The characteristics of trials included in the meta‐analysis and participants' baseline characteristics are summarized in Table . Oral semaglutide, either as monotherapy or as add‐on treatment, was compared with placebo in six trials, and with other glucose‐lowering agents (liraglutide, semaglutide weekly, sitagliptin and empagliflozin) in five trials . Notably, from a phase 2 dose‐finding trial, we extracted data for safety outcomes from the 2.5, 5 and 10 mg arms, while for two trials initially identified as conference abstracts, we used additional data from subsequently published full text reports .…”
Section: Resultsmentioning
confidence: 99%
See 1 more Smart Citation
“…The characteristics of trials included in the meta‐analysis and participants' baseline characteristics are summarized in Table . Oral semaglutide, either as monotherapy or as add‐on treatment, was compared with placebo in six trials, and with other glucose‐lowering agents (liraglutide, semaglutide weekly, sitagliptin and empagliflozin) in five trials . Notably, from a phase 2 dose‐finding trial, we extracted data for safety outcomes from the 2.5, 5 and 10 mg arms, while for two trials initially identified as conference abstracts, we used additional data from subsequently published full text reports .…”
Section: Resultsmentioning
confidence: 99%
“…Oral semaglutide, either as monotherapy or as add-on treatment, was compared with placebo in six trials, [24][25][26][27][28][29] and with other glucose-lowering agents (liraglutide, semaglutide weekly, sitagliptin and empagliflozin) in five trials. 27,[29][30][31][32] Notably, from a phase 2 dose-finding trial, we extracted data for safety outcomes from the 2.5, 5 and 10 mg arms, 29 while for two trials initially identified as conference abstracts, we used additional data from subsequently published full text reports. 28,30 All of the studies had a parallel group design and seven of them were doubleblind.…”
Section: Search Results and Study Characteristicsmentioning
confidence: 99%
“…The trial demonstrated no excess in the risk of 3‐point MACE (2.9% vs. 3.7%; HR 0.79; 95% CI 0.57–1.11) and no increase in HF hospitalisation (1.3% vs. 1.5%; HR 0.86; 95% CI 0.48–1.55) with oral semaglutide compared with placebo . Furthermore, the results of PIONEER 7 (Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes) suggest that flexible dose‐adjusted oral semaglutide can provide superior glycaemic control and weight loss compared with sitagliptin, with safety characteristics similar to subcutaneous GLP‐1 RAs . These results open a possibility to further explore oral GLP‐1 RA as an alternative to the injectable form of these medications.…”
Section: Glucagon Like Peptide‐1 Receptor Agonistsmentioning
confidence: 97%
“…Waiting less than the full 30 min reduces the effect of oral semaglutide. The dosing conditions of oral semaglutide have been described in more detail in previous publications and the prescribing information [4][5][6][7][8][9][10][11][12] .…”
Section: Introductionmentioning
confidence: 99%
“…The efficacy and safety of oral semaglutide was assessed in the PIONEER clinical trial program, which was comprised of a series of global phase 3 studies, comparing oral semaglutide (3, 7, or 14 mg) with placebo, empagliflozin 25 mg, sitagliptin 100 mg, and liraglutide 1.8 mg, with a further study to establish cardiovascular safety [4][5][6][7][8][9][10][11]13 . An additional two phase 3 studies comparing oral semaglutide with liraglutide 0.9 mg and dulaglutide 0.75 mg were conducted in Japan 14,15 .…”
Section: Introductionmentioning
confidence: 99%