Long-term efficacy and safety of combined insulin and glucagon-like peptide-1 therapy: Evidence from the LEADER trial.

Tack CJ, Jacob S, Desouza C, Bain SC, Buse JB, Nauck MA, Petrie JR, Poulter NR, Pratley RE, Stegmann HVBK, Bosch-Traberg H, Startseva E, Zinman B

Diabetes, obesity & metabolism7 Jul 2019Cited by 10 (Europe PMC)

PMID31282028PMCIDPMC6852575DOI10.1111/dom.13826PepBankPUB-31282028

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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, liraglutide reduced HbA1c versus placebo in all three baseline insulin subgroups.
In plain wordsIn adults with type 2 diabetes and high heart risk, liraglutide lowered HbA1c more than placebo whether or not they used insulin.
Peptide
Liraglutide
Outcome
DecreaseHbA1c versus placebo by baseline insulin use
Study
n = 9,340
Comparator
Placebo (plus standard of care)
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
Liraglutide reduced HbA1c and weight versus placebo in all three subgroups (P < .001)
1 context sentence(design, population, supporting numbers)
Summary · context
LEADER assessed cardiovascular (CV) safety and efficacy of liraglutide (1.8 mg) versus placebo (plus standard of care therapy) in 9340 patients with type 2 diabetes and high risk of CV disease, for up to 5 years.
Report a problemFND-3128202801
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, liraglutide reduced weight versus placebo in all three baseline insulin subgroups.
In plain wordsIn adults with type 2 diabetes and high heart risk, liraglutide reduced weight more than placebo whether or not they used insulin.
Peptide
Liraglutide
Outcome
DecreaseBody weight versus placebo by baseline insulin use
Study
n = 9,340
Comparator
Placebo (plus standard of care)
Outcome group
Body weight · Metabolic and weight
Studied dose
1.8 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
Liraglutide reduced HbA1c and weight versus placebo in all three subgroups (P < .001)
1 context sentence(design, population, supporting numbers)
Summary · context
LEADER assessed cardiovascular (CV) safety and efficacy of liraglutide (1.8 mg) versus placebo (plus standard of care therapy) in 9340 patients with type 2 diabetes and high risk of CV disease, for up to 5 years.
Report a problemFND-3128202802
03HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes using basal-only insulin, liraglutide reduced the severe hypoglycaemia rate versus placebo.
In plain wordsIn adults with type 2 diabetes using basal insulin only, liraglutide lowered the rate of severe low blood sugar compared with placebo.
Peptide
Liraglutide
Outcome
DecreaseSevere hypoglycaemia rate in the basal-only insulin subgroup
Study
n = 3,159
Comparator
Placebo (plus standard of care)
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.8 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
and severe hypoglycaemia rate in the basal-only insulin subgroup.
2 context sentences(design, population, supporting numbers)
Summary · context
At baseline, 5171 (55%) patients were not receiving insulin, 3159 (34%) were receiving basal-only insulin and 1010 (11%) other insulins.
Summary · context
LEADER assessed cardiovascular (CV) safety and efficacy of liraglutide (1.8 mg) versus placebo (plus standard of care therapy) in 9340 patients with type 2 diabetes and high risk of CV disease, for up to 5 years.
Report a problemFND-3128202803
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes at high cardiovascular risk, the need for insulin was less with liraglutide than with placebo.
In plain wordsIn adults with type 2 diabetes and high heart risk, liraglutide users needed less insulin than placebo users.
Peptide
Liraglutide
Outcome
DecreaseNeed for insulin
Study
n: not reported in source
Comparator
Placebo (plus standard of care)
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
The need for insulin was less with liraglutide.
1 context sentence(design, population, supporting numbers)
Summary · context
LEADER assessed cardiovascular (CV) safety and efficacy of liraglutide (1.8 mg) versus placebo (plus standard of care therapy) in 9340 patients with type 2 diabetes and high risk of CV disease, for up to 5 years.
Report a problemFND-3128202804
05HumanRandomized controlled trialEfficacy outcome
In the basal-only insulin and no-insulin subgroups, the cardiovascular risk reduction with liraglutide was similar to the main LEADER trial results.
In plain wordsIn people on basal insulin only or no insulin, liraglutide lowered heart risk about as much as in the main trial.
Peptide
Liraglutide
Outcome
DecreaseCardiovascular risk reduction in basal-only and no-insulin subgroups
Study
n: not reported in source
Comparator
Placebo (plus standard of care)
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
1.8 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
CV risk reduction with liraglutide was similar to the main trial results in the basal-only and no-insulin subgroups.
1 context sentence(design, population, supporting numbers)
Summary · context
LEADER assessed cardiovascular (CV) safety and efficacy of liraglutide (1.8 mg) versus placebo (plus standard of care therapy) in 9340 patients with type 2 diabetes and high risk of CV disease, for up to 5 years.
Report a problemFND-3128202805
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on insulin, liraglutide was not associated with an increased risk of severe hypoglycaemia versus placebo.
In plain wordsIn adults with type 2 diabetes on insulin, liraglutide did not raise the risk of severe low blood sugar compared with placebo.
Peptide
Liraglutide
Outcome
No significant changeSevere hypoglycaemia risk in patients on insulin
Study
n: not reported in source
Comparator
Placebo (plus standard of care)
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.8 mg · up to 5 yearsAs given in this study (human).
Source sentences
Summary
with no increased risk of severe hypoglycaemia
1 context sentence(design, population, supporting numbers)
Summary · context
LEADER assessed cardiovascular (CV) safety and efficacy of liraglutide (1.8 mg) versus placebo (plus standard of care therapy) in 9340 patients with type 2 diabetes and high risk of CV disease, for up to 5 years.
Report a problemFND-3128202806

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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