Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome.

Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ and 4 more

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Probstfield JL, Riddle MC, Solomon SD, Tardif JC

The New England journal of medicine1 Dec 2015Cited by 1,765 (Europe PMC)

PMID26630143DOI10.1056/nejmoa1509225PepBankPUB-26630143

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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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with diabetes and recent coronary events, lixisenatide had 13.4% versus 13.2% composite events, meeting noninferiority but not superiority versus placebo.
In plain wordsIn patients with diabetes and recent coronary events, lixisenatide met noninferiority criteria versus placebo but did not significantly reduce composite cardiovascular events.
Peptide
Lixisenatide
Outcome
No significant changeComposite cardiovascular endpoint
Study
n = 6,068
Comparator
Placebo
Analysis
Primary
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
Dose not stated
Measurements
Patients with endpoint
406 patients
lixisenatide
Incidence
13.4%
lixisenatide
Patients with endpoint
399 patients
placebo
Incidence
13.2%
placebo
Hazard ratio
1.02
lixisenatide versus placebo
95% CI lower
0.89
hazard ratio
95% CI upper
1.17
hazard ratio
Noninferiority P
< 0.001
lixisenatide versus placebo
1 more measurement in the study.
Source sentences
Summary
A primary end-point event occurred in 406 patients (13.4%) in the lixisenatide group and in 399 (13.2%) in the placebo group (hazard ratio, 1.02; 95% confidence interval [CI], 0.89 to 1.17), which showed the noninferiority of lixisenatide to placebo (P<0.001) but did not show superiority (P=0.81).
2 context sentences(design, population, supporting numbers)
Summary · context
for the primary composite end point of cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina.
Summary · context
We randomly assigned patients with type 2 diabetes who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days to receive lixisenatide or placebo in addition to locally determined standards of care.
Report a problemFND-2663014301
02HumanRandomized controlled trialEfficacy outcome
In patients with diabetes and recent coronary events, heart-failure hospitalization had a lixisenatide-versus-placebo hazard ratio of 0.96, without a significant difference.
In plain wordsIn patients with diabetes and recent coronary events, heart-failure hospitalization did not differ significantly between lixisenatide and placebo.
Peptide
Lixisenatide
Outcome
No significant changeHospitalization for heart failure
Study
n = 6,068
Comparator
Placebo
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
Dose not stated
Measurements
Hazard ratio
0.96
lixisenatide versus placebo
95% CI lower
0.75
hazard ratio
95% CI upper
1.23
hazard ratio
Source sentences
Summary
There were no significant between-group differences in the rate of hospitalization for heart failure (hazard ratio in the lixisenatide group, 0.96; 95% CI, 0.75 to 1.23) or the rate of death (hazard ratio, 0.94; 95% CI, 0.78 to 1.13).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients with type 2 diabetes who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days to receive lixisenatide or placebo in addition to locally determined standards of care.
Report a problemFND-2663014302
03HumanRandomized controlled trialSafety outcome
In patients with diabetes and recent coronary events, death had a lixisenatide-versus-placebo hazard ratio of 0.94, without a significant difference.
In plain wordsIn patients with diabetes and recent coronary events, death rates did not differ significantly between lixisenatide and placebo.
Peptide
Lixisenatide
Outcome
No significant changeDeath
Study
n = 6,068
Comparator
Placebo
Outcome group
Mortality · Whole body
Studied dose
Dose not stated
Measurements
Hazard ratio
0.94
lixisenatide versus placebo
95% CI lower
0.78
hazard ratio
95% CI upper
1.13
hazard ratio
Source sentences
Summary
There were no significant between-group differences in the rate of hospitalization for heart failure (hazard ratio in the lixisenatide group, 0.96; 95% CI, 0.75 to 1.23) or the rate of death (hazard ratio, 0.94; 95% CI, 0.78 to 1.13).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients with type 2 diabetes who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days to receive lixisenatide or placebo in addition to locally determined standards of care.
Report a problemFND-2663014303
04HumanRandomized controlled trialSafety outcome
In patients with diabetes and recent coronary events, lixisenatide was not associated with more serious adverse events than placebo.
In plain wordsIn patients with diabetes and recent coronary events, lixisenatide was not linked to more serious side effects than placebo.
Peptide
Lixisenatide
Outcome
No significant changeSerious adverse events
Study
n = 6,068
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Source sentences
Summary
Lixisenatide was not associated with a higher rate of serious adverse events or severe hypoglycemia, pancreatitis, pancreatic neoplasms, or allergic reactions than was placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients with type 2 diabetes who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days to receive lixisenatide or placebo in addition to locally determined standards of care.
Report a problemFND-2663014304
05HumanRandomized controlled trialSafety outcome
In patients with diabetes and recent coronary events, lixisenatide was not associated with more severe hypoglycemia than placebo.
In plain wordsIn patients with diabetes and recent coronary events, lixisenatide was not linked to more severe low blood sugar events than placebo.
Peptide
Lixisenatide
Outcome
No significant changeSevere hypoglycemia
Study
n = 6,068
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Lixisenatide was not associated with a higher rate of serious adverse events or severe hypoglycemia, pancreatitis, pancreatic neoplasms, or allergic reactions than was placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients with type 2 diabetes who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days to receive lixisenatide or placebo in addition to locally determined standards of care.
Report a problemFND-2663014305
06HumanRandomized controlled trialSafety outcome
In patients with diabetes and recent coronary events, lixisenatide was not associated with more pancreatitis than placebo.
In plain wordsIn patients with diabetes and recent coronary events, lixisenatide was not linked to more pancreas inflammation than placebo.
Peptide
Lixisenatide
Outcome
No significant changePancreatitis
Study
n = 6,068
Comparator
Placebo
Outcome group
Adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Lixisenatide was not associated with a higher rate of serious adverse events or severe hypoglycemia, pancreatitis, pancreatic neoplasms, or allergic reactions than was placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients with type 2 diabetes who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days to receive lixisenatide or placebo in addition to locally determined standards of care.
Report a problemFND-2663014306
07HumanRandomized controlled trialSafety outcome
In patients with diabetes and recent coronary events, lixisenatide was not associated with more pancreatic neoplasms than placebo.
In plain wordsIn patients with diabetes and recent coronary events, lixisenatide was not linked to more pancreatic tumors than placebo.
Peptide
Lixisenatide
Outcome
No significant changePancreatic neoplasms
Study
n = 6,068
Comparator
Placebo
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated
Source sentences
Summary
Lixisenatide was not associated with a higher rate of serious adverse events or severe hypoglycemia, pancreatitis, pancreatic neoplasms, or allergic reactions than was placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients with type 2 diabetes who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days to receive lixisenatide or placebo in addition to locally determined standards of care.
Report a problemFND-2663014307
08HumanRandomized controlled trialSafety outcome
In patients with diabetes and recent coronary events, lixisenatide was not associated with more allergic reactions than placebo.
In plain wordsIn patients with diabetes and recent coronary events, lixisenatide was not linked to more allergic reactions than placebo.
Peptide
Lixisenatide
Outcome
No significant changeAllergic reactions
Study
n = 6,068
Comparator
Placebo
Outcome group
Adverse events · Immune and inflammation
Studied dose
Dose not stated
Source sentences
Summary
Lixisenatide was not associated with a higher rate of serious adverse events or severe hypoglycemia, pancreatitis, pancreatic neoplasms, or allergic reactions than was placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients with type 2 diabetes who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days to receive lixisenatide or placebo in addition to locally determined standards of care.
Report a problemFND-2663014308

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 postedNCT01147250

Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

Sanofin = 6,068Jun 2010 to Feb 2015

Acute Coronary Syndrome

Trial page ClinicalTrials.govUpdated 20 Dec 2016

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
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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