Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

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

The New England journal of medicine11 Jun 2019Cited by 1,463 (Europe PMC)

PMID31185157DOI10.1056/nejmoa1901118PepBankPUB-31185157

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, oral semaglutide was noninferior to placebo for major adverse cardiovascular events, with no significant difference.
In plain wordsIn adults with type 2 diabetes at high heart risk, oral semaglutide was not worse than placebo for major heart events; no significant difference.
Peptide
Semaglutide
Outcome
No significant changeFirst major adverse cardiovascular event
Study
n = 3,183
Comparator
Placebo
Analysis
Primary
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
Dose not stated · oral · median 15.9 monthsAs given in this study (human).
Measurements
Hazard ratio
0.79 ratio
MACE, oral semaglutide vs placebo
Source sentences
Summary
Major adverse cardiovascular events occurred in 61 of 1591 patients (3.8%) in the oral semaglutide group and 76 of 1592 (4.8%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.57 to 1.11; P<0.001 for noninferiority).
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed cardiovascular outcomes of once-daily oral semaglutide in an event-driven, randomized, double-blind, placebo-controlled trial involving patients at high cardiovascular risk (age of ≥50 years with established cardiovascular or chronic kidney disease, or age of ≥60 years with cardiovascula…
Summary · context
A total of 3183 patients were randomly assigned to receive oral semaglutide or placebo.
Report a problemFND-3118515701
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, oral semaglutide lowered the risk of death from cardiovascular causes versus placebo.
In plain wordsIn adults with type 2 diabetes at high heart risk, fewer people died from heart-related causes with oral semaglutide than with placebo.
Peptide
Semaglutide
Outcome
DecreaseDeath from cardiovascular causes
Study
n = 3,183
Comparator
Placebo
Outcome group
Mortality · Cardiovascular
Studied dose
Dose not stated · oral · median 15.9 monthsAs given in this study (human).
Measurements
Hazard ratio
0.49 ratio
CV death, oral semaglutide vs placebo
Source sentences
Summary
death from cardiovascular causes, 15 of 1591 patients (0.9%) in the oral semaglutide group and 30 of 1592 (1.9%) in the placebo group (hazard ratio, 0.49; 95% CI, 0.27 to 0.92)
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed cardiovascular outcomes of once-daily oral semaglutide in an event-driven, randomized, double-blind, placebo-controlled trial involving patients at high cardiovascular risk (age of ≥50 years with established cardiovascular or chronic kidney disease, or age of ≥60 years with cardiovascula…
Summary · context
A total of 3183 patients were randomly assigned to receive oral semaglutide or placebo.
Report a problemFND-3118515702
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, oral semaglutide had no significant effect on nonfatal myocardial infarction versus placebo.
In plain wordsIn adults with type 2 diabetes at high heart risk, oral semaglutide did not significantly change non-deadly heart attacks compared with placebo.
Peptide
Semaglutide
Outcome
No significant changeNonfatal myocardial infarction
Study
n = 3,183
Comparator
Placebo
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
Dose not stated · oral · median 15.9 monthsAs given in this study (human).
Measurements
Hazard ratio
1.18 ratio
nonfatal MI, oral semaglutide vs placebo
Source sentences
Summary
nonfatal myocardial infarction, 37 of 1591 patients (2.3%) and 31 of 1592 (1.9%), respectively (hazard ratio, 1.18; 95% CI, 0.73 to 1.90)
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed cardiovascular outcomes of once-daily oral semaglutide in an event-driven, randomized, double-blind, placebo-controlled trial involving patients at high cardiovascular risk (age of ≥50 years with established cardiovascular or chronic kidney disease, or age of ≥60 years with cardiovascula…
Summary · context
A total of 3183 patients were randomly assigned to receive oral semaglutide or placebo.
Report a problemFND-3118515703
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, oral semaglutide had no significant effect on nonfatal stroke versus placebo.
In plain wordsIn adults with type 2 diabetes at high heart risk, oral semaglutide did not significantly change non-deadly strokes compared with placebo.
Peptide
Semaglutide
Outcome
No significant changeNonfatal stroke
Study
n = 3,183
Comparator
Placebo
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
Dose not stated · oral · median 15.9 monthsAs given in this study (human).
Measurements
Hazard ratio
0.74 ratio
nonfatal stroke, oral semaglutide vs placebo
Source sentences
Summary
nonfatal stroke, 12 of 1591 patients (0.8%) and 16 of 1592 (1.0%), respectively (hazard ratio, 0.74; 95% CI, 0.35 to 1.57)
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed cardiovascular outcomes of once-daily oral semaglutide in an event-driven, randomized, double-blind, placebo-controlled trial involving patients at high cardiovascular risk (age of ≥50 years with established cardiovascular or chronic kidney disease, or age of ≥60 years with cardiovascula…
Summary · context
A total of 3183 patients were randomly assigned to receive oral semaglutide or placebo.
Report a problemFND-3118515704
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, oral semaglutide lowered the risk of death from any cause versus placebo.
In plain wordsIn adults with type 2 diabetes at high heart risk, fewer people died from any cause with oral semaglutide than with placebo.
Peptide
Semaglutide
Outcome
DecreaseDeath from any cause
Study
n = 3,183
Comparator
Placebo
Outcome group
Mortality · Whole body
Studied dose
Dose not stated · oral · median 15.9 monthsAs given in this study (human).
Measurements
Hazard ratio
0.51 ratio
all-cause death, oral semaglutide vs placebo
Source sentences
Summary
Death from any cause occurred in 23 of 1591 patients (1.4%) in the oral semaglutide group and 45 of 1592 (2.8%) in the placebo group (hazard ratio, 0.51; 95% CI, 0.31 to 0.84).
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed cardiovascular outcomes of once-daily oral semaglutide in an event-driven, randomized, double-blind, placebo-controlled trial involving patients at high cardiovascular risk (age of ≥50 years with established cardiovascular or chronic kidney disease, or age of ≥60 years with cardiovascula…
Summary · context
A total of 3183 patients were randomly assigned to receive oral semaglutide or placebo.
Report a problemFND-3118515705
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes at high cardiovascular risk, gastrointestinal adverse events leading to discontinuation were more common with oral semaglutide than with placebo.
In plain wordsIn adults with type 2 diabetes at high heart risk, more people stopped oral semaglutide than placebo because of gut side effects.
Peptide
Semaglutide
Outcome
IncreaseGastrointestinal adverse events leading to discontinuation
Study
n = 3,183
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · oral · median 15.9 monthsAs given in this study (human).
Source sentences
Summary
Gastrointestinal adverse events leading to discontinuation of oral semaglutide or placebo were more common with oral semaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed cardiovascular outcomes of once-daily oral semaglutide in an event-driven, randomized, double-blind, placebo-controlled trial involving patients at high cardiovascular risk (age of ≥50 years with established cardiovascular or chronic kidney disease, or age of ≥60 years with cardiovascula…
Summary · context
A total of 3183 patients were randomly assigned to receive oral semaglutide or placebo.
Report a problemFND-3118515706

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT02692716

A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 3,18317 Jan 2017 to 25 Sept 2018

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 20 Jul 2022

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
9 Oct 2026, 18:17 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

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