Neoplasms Reported With Liraglutide or Placebo in People With Type 2 Diabetes: Results From the LEADER Randomized Trial.

Nauck MA, Jensen TJ, Rosenkilde C, Calanna S, Buse JB

Diabetes care13 Jun 2018Cited by 77 (Europe PMC)

PMID29898902PMCIDPMC6463597DOI10.2337/dc17-1825PepBankPUB-29898902

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 study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and high cardiovascular risk, confirmed neoplasms were 10.1% with liraglutide versus 9.0% with placebo, a difference that was not significant.
In plain wordsIn adults with type 2 diabetes and high heart risk, tumours were not significantly more common with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
No significant changeConfirmed neoplasms
Study
n = 9,340
Comparator
Placebo
Analysis
Exploratory
Outcome group
Adverse events · Cancer
Studied dose
up to 1.8 mg daily · median follow-up 3.8 yearsAs given in this study (human).
Measurements
Proportion with neoplasm
10.1%
liraglutide
Proportion with neoplasm
9%
placebo
Hazard ratio
1.12 HR
95% CI 0.99-1.28
Source sentences
Summary
Neoplasm was confirmed in 10.1% of patients with liraglutide versus 9.0% with placebo (hazard ratio [HR] 1.12 [95% CI 0.99; 1.28]).
1 context sentence(design, population, supporting numbers)
Summary · context
Participants aged ≥50 years with type 2 diabetes and high cardiovascular risk were assigned 1:1 to receive liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672) in addition to standard care and monitored for 3.5-5 years (median follow-up 3.8 years).
Report a problemFND-2989890201
02HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and high cardiovascular risk, liraglutide did not significantly change the risk of malignant neoplasms versus placebo.
In plain wordsIn adults with type 2 diabetes and high heart risk, cancers were not significantly more common with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
No significant changeMalignant neoplasms
Study
n = 9,340
Comparator
Placebo
Analysis
Exploratory
Outcome group
Adverse events · Cancer
Studied dose
up to 1.8 mg daily · median follow-up 3.8 yearsAs given in this study (human).
Measurements
Hazard ratio
1.06 HR
malignant neoplasms, 95% CI 0.90-1.25
Source sentences
Summary
The HR (95% CI) for liraglutide versus placebo was 1.06 (0.90; 1.25) for malignant neoplasms and 1.16 (0.93; 1.44) for benign neoplasms.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants aged ≥50 years with type 2 diabetes and high cardiovascular risk were assigned 1:1 to receive liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672) in addition to standard care and monitored for 3.5-5 years (median follow-up 3.8 years).
Report a problemFND-2989890202
03HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and high cardiovascular risk, liraglutide did not significantly change the risk of benign neoplasms versus placebo.
In plain wordsIn adults with type 2 diabetes and high heart risk, non-cancerous growths were not significantly more common with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
No significant changeBenign neoplasms
Study
n = 9,340
Comparator
Placebo
Analysis
Exploratory
Outcome group
Adverse events · Cancer
Studied dose
up to 1.8 mg daily · median follow-up 3.8 yearsAs given in this study (human).
Measurements
Hazard ratio
1.16 HR
benign neoplasms, 95% CI 0.93-1.44
Source sentences
Summary
The HR (95% CI) for liraglutide versus placebo was 1.06 (0.90; 1.25) for malignant neoplasms and 1.16 (0.93; 1.44) for benign neoplasms
1 context sentence(design, population, supporting numbers)
Summary · context
Participants aged ≥50 years with type 2 diabetes and high cardiovascular risk were assigned 1:1 to receive liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672) in addition to standard care and monitored for 3.5-5 years (median follow-up 3.8 years).
Report a problemFND-2989890203
04HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and high cardiovascular risk, the hazard ratio confidence interval for pancreatic neoplasms with liraglutide versus placebo included one.
In plain wordsIn adults with type 2 diabetes and high heart risk, liraglutide did not clearly change pancreatic tumour risk compared with placebo.
Peptide
Liraglutide
Outcome
No significant changePancreatic neoplasms
Study
n = 9,340
Comparator
Placebo
Analysis
Exploratory
Outcome group
Adverse events · Cancer
Studied dose
up to 1.8 mg daily · median follow-up 3.8 yearsAs given in this study (human).
Source sentences
Summary
In our main analyses, the 95% CI for the HR included one for all malignant neoplasms evaluated (including pancreatic and thyroid neoplasms) except for prostate neoplasms, which occurred in fewer liraglutide-treated patients.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants aged ≥50 years with type 2 diabetes and high cardiovascular risk were assigned 1:1 to receive liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672) in addition to standard care and monitored for 3.5-5 years (median follow-up 3.8 years).
Report a problemFND-2989890204
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and high cardiovascular risk, the hazard ratio confidence interval for thyroid neoplasms with liraglutide versus placebo included one.
In plain wordsIn adults with type 2 diabetes and high heart risk, liraglutide did not clearly change thyroid tumour risk compared with placebo.
Peptide
Liraglutide
Outcome
No significant changeThyroid neoplasms
Study
n = 9,340
Comparator
Placebo
Analysis
Exploratory
Outcome group
Adverse events · Cancer
Studied dose
up to 1.8 mg daily · median follow-up 3.8 yearsAs given in this study (human).
Source sentences
Summary
In our main analyses, the 95% CI for the HR included one for all malignant neoplasms evaluated (including pancreatic and thyroid neoplasms) except for prostate neoplasms, which occurred in fewer liraglutide-treated patients.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants aged ≥50 years with type 2 diabetes and high cardiovascular risk were assigned 1:1 to receive liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672) in addition to standard care and monitored for 3.5-5 years (median follow-up 3.8 years).
Report a problemFND-2989890205
06HumanRandomized controlled trialSafety outcome
In men with type 2 diabetes and high cardiovascular risk, prostate neoplasms occurred in fewer liraglutide-treated patients than placebo-treated patients.
In plain wordsIn men with type 2 diabetes and high heart risk, fewer prostate tumours occurred with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
DecreaseProstate neoplasms
Study
n = 9,340
Comparator
Placebo
Analysis
Exploratory
Outcome group
Adverse events · Cancer
Studied dose
up to 1.8 mg daily · median follow-up 3.8 yearsAs given in this study (human).
Source sentences
Summary
except for prostate neoplasms, which occurred in fewer liraglutide-treated patients.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants aged ≥50 years with type 2 diabetes and high cardiovascular risk were assigned 1:1 to receive liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672) in addition to standard care and monitored for 3.5-5 years (median follow-up 3.8 years).
Report a problemFND-2989890206
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and high cardiovascular risk, sensitivity analyses excluding early neoplasms and analyses by sex gave results similar to the main neoplasm analysis.
In plain wordsIn adults with type 2 diabetes and high heart risk, extra checks of the tumour results gave similar answers.
Peptide
Liraglutide
Outcome
No significant changeNeoplasms in sensitivity analyses
Study
n = 9,340
Comparator
Placebo
Analysis
Exploratory
Outcome group
Adverse events · Cancer
Studied dose
up to 1.8 mg daily · median follow-up 3.8 yearsAs given in this study (human).
Source sentences
Summary
Sensitivity analyses excluding neoplasms occurring <1 year or <2 years after randomization and analyses by sex provided similar results.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants aged ≥50 years with type 2 diabetes and high cardiovascular risk were assigned 1:1 to receive liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672) in addition to standard care and monitored for 3.5-5 years (median follow-up 3.8 years).
Report a problemFND-2989890207

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 postedNCT01179048

Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results

Novo Nordisk A/Sn = 9,34131 Aug 2010 to 17 Dec 2015

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 17 Jul 2019

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
12 Oct 2026, 12:10 UTC
Study results updated
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.