The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Complications in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events: Results From the LEADER Trial.

Dhatariya K, Bain SC, Buse JB, Simpson R, Tarnow L, Kaltoft MS, Stellfeld M, Tornøe K, Pratley RE

Diabetes care2 Aug 2018Cited by 107 (Europe PMC)

PMID30072400PMCIDPMC6150424DOI10.2337/dc18-1094PepBankPUB-30072400

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 study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, similar proportions had at least one foot ulcer with liraglutide and with placebo.
In plain wordsIn adults with type 2 diabetes at high heart risk, liraglutide and placebo gave similar rates of foot ulcers.
Peptide
Liraglutide
Outcome
No significant changeIncidence of diabetic foot ulcer
Study
n = 9,340
Comparator
Placebo
Outcome group
Diabetes complications · Skin and wound
Studied dose
1.8 mg/day · up to 5 yearsAs given in this study (human).
Measurements
DFU incidence
3.8%
liraglutide
DFU incidence
4.1%
placebo
Hazard ratio
0.92 HR
liraglutide vs placebo
Source sentences
Summary
During a median of 3.8 years' follow-up, similar proportions of patients reported at least one episode of DFU in the liraglutide and placebo groups (3.8% [176/4,668] versus 4.1% [191/4,672], respectively; hazard ratio [HR] 0.92 [95% CI 0.75, 1.13; P = 0.41]).
1 context sentence(design, population, supporting numbers)
Summary · context
The LEADER trial (NCT01179048) was a randomized, double-blind, multicenter, CV outcomes trial assessing liraglutide (1.8 mg/day) versus placebo, in addition to standard of care, for up to 5 years.
Report a problemFND-3007240001
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, liraglutide significantly reduced amputations related to foot ulcers versus placebo.
In plain wordsIn adults with type 2 diabetes at high heart risk, liraglutide was linked to fewer foot-ulcer amputations than placebo; this may be due to chance.
Peptide
Liraglutide
Outcome
DecreaseAmputations related to foot ulcers
Study
n: not reported in source
Comparator
Placebo
Outcome group
Diabetes complications · Skin and wound
Studied dose
1.8 mg/day · up to 5 yearsAs given in this study (human).
Measurements
Hazard ratio
0.65 HR
amputation, liraglutide vs placebo
Source sentences
Summary
Analysis of DFU-related complications demonstrated a significant reduction in amputations with liraglutide versus placebo (HR 0.65 [95% CI 0.45, 0.95; P = 0.03]).
1 context sentence(design, population, supporting numbers)
Summary · context
The LEADER trial (NCT01179048) was a randomized, double-blind, multicenter, CV outcomes trial assessing liraglutide (1.8 mg/day) versus placebo, in addition to standard of care, for up to 5 years.
Report a problemFND-3007240002
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, liraglutide did not differ from placebo for foot infections in the main analysis.
In plain wordsIn adults with type 2 diabetes at high heart risk, liraglutide and placebo did not differ in foot infections.
Peptide
Liraglutide
Outcome
No significant changeFoot infections
Study
n: not reported in source
Comparator
Placebo
Outcome group
Diabetes complications · Skin and wound
Studied dose
1.8 mg/day · up to 5 yearsAs given in this study (human).
Source sentences
Summary
However, no differences were found for foot infections, involvement of underlying structures, or peripheral revascularization in the main analysis.
1 context sentence(design, population, supporting numbers)
Summary · context
The LEADER trial (NCT01179048) was a randomized, double-blind, multicenter, CV outcomes trial assessing liraglutide (1.8 mg/day) versus placebo, in addition to standard of care, for up to 5 years.
Report a problemFND-3007240003
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, liraglutide did not differ from placebo for involvement of structures under foot ulcers in the main analysis.
In plain wordsIn adults with type 2 diabetes at high heart risk, liraglutide and placebo did not differ in how deep foot ulcers reached.
Peptide
Liraglutide
Outcome
No significant changeInvolvement of underlying structures
Study
n: not reported in source
Comparator
Placebo
Outcome group
Diabetes complications · Skin and wound
Studied dose
1.8 mg/day · up to 5 yearsAs given in this study (human).
Source sentences
Summary
However, no differences were found for foot infections, involvement of underlying structures, or peripheral revascularization in the main analysis.
1 context sentence(design, population, supporting numbers)
Summary · context
The LEADER trial (NCT01179048) was a randomized, double-blind, multicenter, CV outcomes trial assessing liraglutide (1.8 mg/day) versus placebo, in addition to standard of care, for up to 5 years.
Report a problemFND-3007240004
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, liraglutide did not differ from placebo for peripheral revascularization in the main analysis.
In plain wordsIn adults with type 2 diabetes at high heart risk, liraglutide and placebo did not differ in procedures to restore leg blood flow.
Peptide
Liraglutide
Outcome
No significant changePeripheral revascularization
Study
n: not reported in source
Comparator
Placebo
Outcome group
Diabetes complications · Skin and wound
Studied dose
1.8 mg/day · up to 5 yearsAs given in this study (human).
Source sentences
Summary
However, no differences were found for foot infections, involvement of underlying structures, or peripheral revascularization in the main analysis.
1 context sentence(design, population, supporting numbers)
Summary · context
The LEADER trial (NCT01179048) was a randomized, double-blind, multicenter, CV outcomes trial assessing liraglutide (1.8 mg/day) versus placebo, in addition to standard of care, for up to 5 years.
Report a problemFND-3007240005

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

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