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Study · Randomized controlled trial · 2018

3 results

No Evidence of Increase in Calcitonin Concentrations or Development of C-Cell Malignancy in Response to Liraglutide for Up to 5 Years in the LEADER Trial.

Hegedüs L, Sherman SI, Tuttle RM, von Scholten BJ, Rasmussen S, Karsbøl JD, Daniels GH

Diabetes care26 Dec 2017Cited by 47 (Europe PMC)

PMID29279300 (opens in a new tab)DOI10.2337/dc17-1956 (opens in a new tab)PepBankPUB-29279300
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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 study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In men with type 2 diabetes at high cardiovascular risk, liraglutide did not increase calcitonin concentrations versus placebo at 36 months (estimated treatment ratio 1.03).

    In plain wordsIn men with type 2 diabetes at high heart risk, liraglutide did not raise calcitonin levels compared with placebo.

    Peptide
    Liraglutide
    Outcome
    No significant changeCalcitonin concentration at 36 months, men
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    Dose not stated · 3.5-5 yearsAs given in this study (human).

    Measurements

    Estimated treatment ratio
    1.03 ratio
    male subgroup

    Source sentences

    Summary
    At 36 months, patients randomized to liraglutide versus placebo showed no evidence of increase in calcitonin concentrations in male (estimated treatment ratio [ETR] 1.03 [95% CI 1.00, 1.06]; P = 0.068)
    1 context sentence
    Summary · context
    Patients (n = 9,340) with type 2 diabetes and high risk for cardiovascular events were randomized 1:1 to liraglutide or placebo.
  2. 02HumanRandomized controlled trialSafety outcome

    In women with type 2 diabetes at high cardiovascular risk, liraglutide did not increase calcitonin concentrations versus placebo at 36 months (estimated treatment ratio 1.00).

    In plain wordsIn women with type 2 diabetes at high heart risk, liraglutide did not raise calcitonin levels compared with placebo.

    Peptide
    Liraglutide
    Outcome
    No significant changeCalcitonin concentration at 36 months, women
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    Dose not stated · 3.5-5 yearsAs given in this study (human).

    Measurements

    Estimated treatment ratio
    1 ratio
    female subgroup

    Source sentences

    Summary
    At 36 months, patients randomized to liraglutide versus placebo showed no evidence of increase in calcitonin concentrations
    2 context sentences
    Summary · context
    female (ETR 1.00 [95% CI 0.97, 1.02]; P = 0.671)
    Summary · context
    Patients (n = 9,340) with type 2 diabetes and high risk for cardiovascular events were randomized 1:1 to liraglutide or placebo.
  3. 03HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes at high cardiovascular risk, no episodes of C-cell hyperplasia or medullary thyroid carcinoma occurred in liraglutide-treated patients.

    In plain wordsIn adults with type 2 diabetes at high heart risk, no one on liraglutide had C-cell overgrowth or medullary thyroid cancer.

    Peptide
    Liraglutide
    Outcome
    No significant changeC-cell hyperplasia or medullary thyroid carcinoma
    Study

    n: not reported in source

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    Dose not stated · 3.5-5 yearsAs given in this study (human).

    Source sentences

    Summary
    There were no episodes of C-cell hyperplasia or medullary thyroid carcinoma in liraglutide-treated patients.
    1 context sentence
    Summary · context
    Patients (n = 9,340) with type 2 diabetes and high risk for cardiovascular events were randomized 1:1 to liraglutide or placebo.

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 pageClinicalTrials.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.

  1. Version 2Current

    12 Oct 2026, 12:10 UTC

    Study results updated

  2. 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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