Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

Holman RR, Bethel MA, Mentz RJ, Thompson VP, Lokhnygina Y, Buse JB, Chan JC, Choi J, Gustavson SM, Iqbal N, Maggioni AP, Marso SP and 6 more

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Öhman P, Pagidipati NJ, Poulter N, Ramachandran A, Zinman B, Hernandez AF

The New England journal of medicine14 Sept 2017Cited by 1,607 (Europe PMC)

PMID28910237PMCIDPMC9792409DOI10.1056/nejmoa1612917PepBankPUB-28910237

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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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide did not significantly reduce the primary composite cardiovascular outcome versus placebo.
In plain wordsIn type 2 diabetes, exenatide did not significantly reduce the combined cardiovascular outcome compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changePrimary composite cardiovascular outcome superiority
Study
n = 14,752
Comparator
Placebo
Analysis
Primary
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
2 mg once weekly · subcutaneousAs given in this study (human).
Measurements
Primary composite outcome incidence
11.4%
exenatide group
Primary composite outcome incidence
12.2%
placebo group
Hazard ratio
0.91 ratio
exenatide versus placebo (95% CI 0.83 to 1.00)
P value for superiority
0.06 P
exenatide versus placebo
Source sentences
Summary
A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00)
Summary
with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.
Summary · context
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly.
Report a problemFND-2891023701
02HumanRandomized controlled trialSafety outcome
In type 2 diabetes, exenatide was noninferior to placebo for cardiovascular safety.
In plain wordsIn type 2 diabetes, exenatide met the trial's cardiovascular safety noninferiority criterion compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changePrimary composite cardiovascular outcome noninferiority
Study
n = 14,752
Comparator
Placebo
Analysis
Primary
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
2 mg once weekly · subcutaneousAs given in this study (human).
Measurements
Hazard ratio
0.91 ratio
exenatide versus placebo (95% CI 0.83 to 1.00)
P value for noninferiority
< 0.001 P
exenatide versus placebo
Source sentences
Summary
A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00)
Summary
with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.
Summary · context
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly.
Report a problemFND-2891023702
03HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, cardiovascular death rates did not differ significantly between exenatide and placebo.
In plain wordsIn type 2 diabetes, cardiovascular death rates did not differ significantly between exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeCardiovascular death
Study
n = 14,752
Comparator
Placebo
Outcome group
Mortality · Cardiovascular
Studied dose
2 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome,
2 context sentences(design, population, supporting numbers)
Summary · context
did not differ significantly between the two groups.
Summary · context
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly.
Report a problemFND-2891023703
04HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, fatal or nonfatal myocardial infarction rates did not differ significantly between exenatide and placebo.
In plain wordsIn type 2 diabetes, heart attack rates did not differ significantly between exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeFatal or nonfatal myocardial infarction
Study
n = 14,752
Comparator
Placebo
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
2 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome,
2 context sentences(design, population, supporting numbers)
Summary · context
did not differ significantly between the two groups.
Summary · context
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly.
Report a problemFND-2891023704
05HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, fatal or nonfatal stroke rates did not differ significantly between exenatide and placebo.
In plain wordsIn type 2 diabetes, stroke rates did not differ significantly between exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeFatal or nonfatal stroke
Study
n = 14,752
Comparator
Placebo
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
2 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome,
2 context sentences(design, population, supporting numbers)
Summary · context
did not differ significantly between the two groups.
Summary · context
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly.
Report a problemFND-2891023705
06HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, heart failure hospitalization rates did not differ significantly between exenatide and placebo.
In plain wordsIn type 2 diabetes, heart failure hospitalization rates did not differ significantly between exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHospitalization for heart failure
Study
n = 14,752
Comparator
Placebo
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
2 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome,
2 context sentences(design, population, supporting numbers)
Summary · context
did not differ significantly between the two groups.
Summary · context
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly.
Report a problemFND-2891023706
07HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, acute coronary syndrome hospitalization rates did not differ significantly between exenatide and placebo.
In plain wordsIn type 2 diabetes, acute coronary syndrome hospitalization rates did not differ significantly between exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHospitalization for acute coronary syndrome
Study
n = 14,752
Comparator
Placebo
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
2 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome,
2 context sentences(design, population, supporting numbers)
Summary · context
did not differ significantly between the two groups.
Summary · context
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly.
Report a problemFND-2891023707
08HumanRandomized controlled trialSafety outcome
In type 2 diabetes, acute pancreatitis incidence did not differ significantly between exenatide and placebo.
In plain wordsIn type 2 diabetes, acute pancreatitis incidence did not differ significantly between exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeAcute pancreatitis
Study
n = 14,752
Comparator
Placebo
Outcome group
Adverse events · Gastrointestinal
Studied dose
2 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly.
Report a problemFND-2891023708
09HumanRandomized controlled trialSafety outcome
In type 2 diabetes, pancreatic cancer incidence did not differ significantly between exenatide and placebo.
In plain wordsIn type 2 diabetes, pancreatic cancer incidence did not differ significantly between exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changePancreatic cancer
Study
n = 14,752
Comparator
Placebo
Outcome group
Adverse events · Cancer
Studied dose
2 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly.
Report a problemFND-2891023709
10HumanRandomized controlled trialSafety outcome
In type 2 diabetes, medullary thyroid carcinoma incidence did not differ significantly between exenatide and placebo.
In plain wordsIn type 2 diabetes, medullary thyroid cancer incidence did not differ significantly between exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeMedullary thyroid carcinoma
Study
n = 14,752
Comparator
Placebo
Outcome group
Adverse events · Cancer
Studied dose
2 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly.
Report a problemFND-2891023710
11HumanRandomized controlled trialSafety outcome
In type 2 diabetes, serious adverse event incidence did not differ significantly between exenatide and placebo.
In plain wordsIn type 2 diabetes, serious adverse event incidence did not differ significantly between exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeSerious adverse events
Study
n = 14,752
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly.
Report a problemFND-2891023711

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 postedNCT01144338

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus

AstraZenecan = 14,75218 Jun 2010 to 24 Apr 2017

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 8 Aug 2018

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
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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