Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial.

Nauck MA, Muus Ghorbani ML, Kreiner E, Saevereid HA, Buse JB

Diabetes care9 Aug 2019Cited by 51 (Europe PMC)

PMID31399438PMCIDPMC7364668DOI10.2337/dc19-0415PepBankPUB-31399438

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 study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes at high cardiovascular risk, liraglutide increased the risk of acute gallbladder or biliary disease versus placebo (HR 1.60).
In plain wordsIn adults with type 2 diabetes at high heart risk, liraglutide raised the risk of gallbladder or bile duct disease compared with placebo.
Peptide
Liraglutide
Outcome
IncreaseAcute gallbladder or biliary disease
Study
n = 9,340
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
up to 1.8 mg daily · 3.5-5 yearsAs given in this study (human).
Measurements
Hazard ratio
1.6 HR
liraglutide vs placebo
Patients with events
141 patients
liraglutide
Patients with events
88 patients
placebo
Source sentences
Summary
There was an increased risk of acute gallbladder or biliary disease with liraglutide versus placebo (n = 141 of 4,668 vs. n = 88 of 4,672 patients, respectively; hazard ratio [HR] 1.60; 95% CI 1.23, 2.09; P < 0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
Participants with type 2 diabetes at high risk for CV events (n = 9,340) were randomized 1:1 to receive either liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672), with both groups also receiving standard care (treatment period: 3.5-5 years).
Report a problemFND-3139943801
02HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes at high cardiovascular risk, similar trends of higher risk with liraglutide versus placebo were seen for uncomplicated stones, complicated stones, cholecystitis and biliary obstruction.
In plain wordsIn adults with type 2 diabetes at high heart risk, all four gallbladder or bile duct event types were more likely with liraglutide than placebo.
Peptide
Liraglutide
Outcome
IncreaseFour categories of gallbladder or biliary events
Study
n = 9,340
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
up to 1.8 mg daily · 3.5-5 yearsAs given in this study (human).
Source sentences
Summary
Similar trends were observed for each of the four categories of gallbladder- or biliary tract-related events.
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis categorized captured events of acute gallbladder or biliary disease into four groups: uncomplicated gallbladder stones, complicated gallbladder stones, cholecystitis, and biliary obstruction.
Summary · context
Participants with type 2 diabetes at high risk for CV events (n = 9,340) were randomized 1:1 to receive either liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672), with both groups also receiving standard care (treatment period: 3.5-5 years).
Report a problemFND-3139943802
03HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes at high cardiovascular risk, cholecystectomy was performed more often with liraglutide than with placebo (HR 1.56).
In plain wordsIn adults with type 2 diabetes at high heart risk, gallbladder removal surgery happened more often with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseCholecystectomy
Study
n = 9,340
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
up to 1.8 mg daily · 3.5-5 yearsAs given in this study (human).
Measurements
Hazard ratio
1.56 HR
liraglutide vs placebo
Source sentences
Summary
Cholecystectomy was performed more frequently in liraglutide-treated patients (HR 1.56; 95% CI 1.10, 2.20; P = 0.013)
1 context sentence(design, population, supporting numbers)
Summary · context
Participants with type 2 diabetes at high risk for CV events (n = 9,340) were randomized 1:1 to receive either liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672), with both groups also receiving standard care (treatment period: 3.5-5 years).
Report a problemFND-3139943803
04HumanRandomized controlled trialSafety outcome
Among people with gallbladder or biliary events, similar proportions had cholecystectomy with liraglutide (57%) and placebo (59%).
In plain wordsAmong people who had gallbladder or bile duct events, about the same share had surgery with liraglutide as with placebo.
Peptide
Liraglutide
Outcome
No significant changeCholecystectomy among patients with gallbladder or biliary events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
up to 1.8 mg daily · 3.5-5 yearsAs given in this study (human).
Measurements
Proportion with cholecystectomy
57%
liraglutide
Proportion with cholecystectomy
59%
placebo
Source sentences
Summary
but for similar proportions of the patients who experienced gallbladder- or biliary tract-related events (57% with liraglutide vs. 59% with placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
Participants with type 2 diabetes at high risk for CV events (n = 9,340) were randomized 1:1 to receive either liraglutide (≤1.8 mg daily; n = 4,668) or placebo (n = 4,672), with both groups also receiving standard care (treatment period: 3.5-5 years).
Report a problemFND-3139943804

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.

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