Skip to content

Study · Randomized controlled trial · n = 52 · 2016

4 results

Twelve week liraglutide or sitagliptin does not affect hepatic fat in type 2 diabetes: a randomised placebo-controlled trial.

Smits MM, Tonneijck L, Muskiet MH, Kramer MH, Pouwels PJ, Pieters-van den Bos IC, Hoekstra T, Diamant M, van Raalte DH, Cahen DL

Diabetologia15 Sept 2016Cited by 118 (Europe PMC)

PMID27627981 (opens in a new tab)PMCIDPMC6518065 (opens in a new tab)DOI10.1007/s00125-016-4100-7 (opens in a new tab)PepBankPUB-27627981
Download PDFPubMedAsk about this study
Jump to 4 results

Summary

Aims/hypothesisGlucagon-like peptide (GLP)-1-based therapies have been suggested to improve hepatic steatosis. We assessed the effects of the GLP-1 receptor agonist liraglutide and the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin on hepatic steatosis and fibrosis in patients with type 2 diabetes.MethodsIn this 12 week, parallel, randomised, placebo-controlled trial, performed at the VU University Medical Center between July 2013 and August 2015, 52 overweight patients with type 2 diabetes treated with metformin and/or sulphonylurea agent ([mean ± SD] age 62.7 ± 6.9 years, HbA1c 7.3 ± 0.7% or 56 ± 1 mmol/mol) were allocated to once daily liraglutide 1.8 mg (n = 17), sitagliptin 100 mg (n = 18) or matching placebos (n = 17) by computer generated numbers. Both participants and researchers were blinded to group assignment. Hepatic fat content was measured using proton magnetic resonance spectroscopy (1H-MRS). Hepatic fibrosis was estimated using three validated formulae.ResultsOne patient dropped out in the sitagliptin group owing to dizziness, but no serious adverse events occurred. At week 12, no between-group differences in hepatic steatosis were found. Liraglutide reduced steatosis by 10% (20.9 ± 3.4% to 18.8 ± 3.3%), sitagliptin reduced steatosis by 12.1% (23.9 ± 3.0% to 21.0 ± 2.7%) and placebo lessened it by 9.5% (18.7 ± 2.7% to 16.9 ± 2.7%). Neither drug affected hepatic fibrosis scores compared with placebo.Conclusions/interpretationTwelve-week liraglutide or sitagliptin treatment does not reduce hepatic steatosis or fibrosis in type 2 diabetes.Trial registrationClinicalTrials.gov NCT01744236 FUNDING : Funded by the European Community's Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 282521 - the SAFEGUARD project.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

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

  1. 01HumanRandomized controlled trialSafety outcome

    In this trial of overweight adults with type 2 diabetes, no serious adverse events occurred.

    In plain wordsIn this trial of overweight adults with type 2 diabetes, no serious side effects were reported.

    Peptide
    Liraglutide
    Outcome
    No significant changeSerious adverse events
    Study

    n = 52

    Outcome group
    Adverse events · Whole body
    Studied dose
    1.8 mg once daily · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    One patient dropped out in the sitagliptin group owing to dizziness, but no serious adverse events occurred.
    1 context sentence
    Summary · context
    52 overweight patients with type 2 diabetes treated with metformin and/or sulphonylurea agent ([mean ± SD] age 62.7 ± 6.9 years, HbA1c 7.3 ± 0.7% or 56 ± 1 mmol/mol) were allocated to once daily liraglutide 1.8 mg (n = 17), sitagliptin 100 mg (n = 18) or matching placebos (n = 17) by computer generated numbers
  2. 02HumanRandomized controlled trialEfficacy outcome

    In overweight adults with type 2 diabetes, liraglutide did not reduce hepatic steatosis more than placebo at week 12.

    In plain wordsIn overweight adults with type 2 diabetes, 12 weeks of liraglutide did not reduce liver fat more than placebo.

    Peptide
    Liraglutide
    Outcome
    No significant changeHepatic steatosis (between-group difference)
    Study

    n = 34

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.8 mg once daily · 12 weeksAs given in this study (human).

    Measurements

    Steatosis reduction
    10%
    liraglutide
    Steatosis reduction
    9.5%
    placebo

    Source sentences

    Summary
    At week 12, no between-group differences in hepatic steatosis were found.
    2 context sentences
    Summary · context
    Liraglutide reduced steatosis by 10% (20.9 ± 3.4% to 18.8 ± 3.3%), sitagliptin reduced steatosis by 12.1% (23.9 ± 3.0% to 21.0 ± 2.7%) and placebo lessened it by 9.5% (18.7 ± 2.7% to 16.9 ± 2.7%).
    Summary · context
    52 overweight patients with type 2 diabetes treated with metformin and/or sulphonylurea agent ([mean ± SD] age 62.7 ± 6.9 years, HbA1c 7.3 ± 0.7% or 56 ± 1 mmol/mol) were allocated to once daily liraglutide 1.8 mg (n = 17), sitagliptin 100 mg (n = 18) or matching placebos (n = 17) by computer generated numbers
  3. 03HumanRandomized controlled trialEfficacy outcome

    In overweight adults with type 2 diabetes, liraglutide did not change hepatic fibrosis scores versus placebo.

    In plain wordsIn overweight adults with type 2 diabetes, liraglutide did not change liver scarring scores compared with placebo.

    Peptide
    Liraglutide
    Outcome
    No significant changeHepatic fibrosis scores
    Study

    n = 34

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.8 mg once daily · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Neither drug affected hepatic fibrosis scores compared with placebo.
    1 context sentence
    Summary · context
    52 overweight patients with type 2 diabetes treated with metformin and/or sulphonylurea agent ([mean ± SD] age 62.7 ± 6.9 years, HbA1c 7.3 ± 0.7% or 56 ± 1 mmol/mol) were allocated to once daily liraglutide 1.8 mg (n = 17), sitagliptin 100 mg (n = 18) or matching placebos (n = 17) by computer generated numbers
  4. 04HumanRandomized controlled trialEfficacy outcome

    In overweight adults with type 2 diabetes, hepatic steatosis fell within the liraglutide group, but it also fell in the placebo group, so this is not a liraglutide effect.

    In plain wordsIn overweight adults with type 2 diabetes, liver fat fell with liraglutide, but it fell about as much with placebo.

    Peptide
    Liraglutide
    Outcome
    DecreaseHepatic steatosis change from baseline
    Study

    n = 17

    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.8 mg once daily · 12 weeksAs given in this study (human).

    Measurements

    Hepatic steatosis baseline
    20.9%
    liraglutide
    Hepatic steatosis week 12
    18.8%
    liraglutide

    Source sentences

    Summary
    Liraglutide reduced steatosis by 10% (20.9 ± 3.4% to 18.8 ± 3.3%), sitagliptin reduced steatosis by 12.1% (23.9 ± 3.0% to 21.0 ± 2.7%) and placebo lessened it by 9.5% (18.7 ± 2.7% to 16.9 ± 2.7%).
    1 context sentence
    Summary · context
    52 overweight patients with type 2 diabetes treated with metformin and/or sulphonylurea agent ([mean ± SD] age 62.7 ± 6.9 years, HbA1c 7.3 ± 0.7% or 56 ± 1 mmol/mol) were allocated to once daily liraglutide 1.8 mg (n = 17), sitagliptin 100 mg (n = 18) or matching placebos (n = 17) by computer generated numbers

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT01744236

SAFEGUARD: Pleiotropic Effects of Incretin Based Therapies

Amsterdam UMC, location VUmcn = 70Apr 2013 to Aug 2015

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 9 Dec 2015

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.

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