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Study · Randomized controlled trial · 2016

5 results

Biliary effects of liraglutide and sitagliptin, a 12-week randomized placebo-controlled trial in type 2 diabetes patients.

Smits MM, Tonneijck L, Muskiet MH, Hoekstra T, Kramer MH, Diamant M, Nieuwdorp M, Groen AK, Cahen DL, van Raalte DH

Diabetes, obesity & metabolism30 Aug 2016Cited by 50 (Europe PMC)

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 study5

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, liraglutide had no effect on gallbladder fasting volume versus placebo.

    In plain wordsIn adults with type 2 diabetes, liraglutide did not change gallbladder volume compared with placebo.

    Outcome
    No significant changeGallbladder fasting volume
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Neither liraglutide nor sitagliptin had an effect on gallbladder fasting volume and ejection fraction (p > .05).
    2 context sentences
    Summary · context
    A total of 57 type 2 diabetes patients (mean ± SD age, 62.8 ± 6.9 years; BMI, 31.8 ± 4.1 kg/m2 ; HbA1c, 7.3% ± 0.6%), treated with metformin and/or sulfonylureas, were included in this 12-week randomized, placebo-controlled, double-blind, single-centre trial between July 2013 and August 2…
    Summary · context
    Patients received the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebo for 12 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, liraglutide had no effect on gallbladder ejection fraction versus placebo.

    In plain wordsIn adults with type 2 diabetes, liraglutide did not change how well the gallbladder emptied compared with placebo.

    Outcome
    No significant changeGallbladder ejection fraction
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Neither liraglutide nor sitagliptin had an effect on gallbladder fasting volume and ejection fraction (p > .05).
    2 context sentences
    Summary · context
    A total of 57 type 2 diabetes patients (mean ± SD age, 62.8 ± 6.9 years; BMI, 31.8 ± 4.1 kg/m2 ; HbA1c, 7.3% ± 0.6%), treated with metformin and/or sulfonylureas, were included in this 12-week randomized, placebo-controlled, double-blind, single-centre trial between July 2013 and August 2…
    Summary · context
    Patients received the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebo for 12 weeks.
  3. 03HumanRandomized controlled trialMechanism

    In adults with type 2 diabetes, liraglutide increased fasting serum deoxycholic acid versus placebo.

    In plain wordsIn adults with type 2 diabetes, liraglutide raised fasting blood levels of the bile acid deoxycholic acid compared with placebo.

    Outcome
    IncreaseFasting serum deoxycholic acid
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Measurements

    Deoxycholic acid difference
    0.2 µmol/L
    fasting serum

    Source sentences

    Summary
    Liraglutide increased serum levels of deoxycholic acid in the fasting state [0.20 µmol/L (95% CI 0.027-0.376), p = 0.024] and postprandial state [AUC 40.71 (13.22-68.21), p = 0.005] and in faeces [ratio 1.5 (1.03-2.19); p = 0.035].
    2 context sentences
    Summary · context
    A total of 57 type 2 diabetes patients (mean ± SD age, 62.8 ± 6.9 years; BMI, 31.8 ± 4.1 kg/m2 ; HbA1c, 7.3% ± 0.6%), treated with metformin and/or sulfonylureas, were included in this 12-week randomized, placebo-controlled, double-blind, single-centre trial between July 2013 and August 2…
    Summary · context
    Patients received the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebo for 12 weeks.
  4. 04HumanRandomized controlled trialMechanism

    In adults with type 2 diabetes, liraglutide increased postprandial serum deoxycholic acid versus placebo.

    In plain wordsIn adults with type 2 diabetes, liraglutide raised blood levels of the bile acid deoxycholic acid after a meal compared with placebo.

    Outcome
    IncreasePostprandial serum deoxycholic acid
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Measurements

    Deoxycholic acid AUC difference
    40.71 AUC
    postprandial serum

    Source sentences

    Summary
    Liraglutide increased serum levels of deoxycholic acid in the fasting state [0.20 µmol/L (95% CI 0.027-0.376), p = 0.024] and postprandial state [AUC 40.71 (13.22-68.21), p = 0.005] and in faeces [ratio 1.5 (1.03-2.19); p = 0.035].
    2 context sentences
    Summary · context
    A total of 57 type 2 diabetes patients (mean ± SD age, 62.8 ± 6.9 years; BMI, 31.8 ± 4.1 kg/m2 ; HbA1c, 7.3% ± 0.6%), treated with metformin and/or sulfonylureas, were included in this 12-week randomized, placebo-controlled, double-blind, single-centre trial between July 2013 and August 2…
    Summary · context
    Patients received the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebo for 12 weeks.
  5. 05HumanRandomized controlled trialMechanism

    In adults with type 2 diabetes, liraglutide increased faecal deoxycholic acid versus placebo.

    In plain wordsIn adults with type 2 diabetes, liraglutide raised stool levels of the bile acid deoxycholic acid compared with placebo.

    Outcome
    IncreaseFaecal deoxycholic acid
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Measurements

    Faecal deoxycholic acid ratio
    1.5 ratio
    faeces

    Source sentences

    Summary
    Liraglutide increased serum levels of deoxycholic acid in the fasting state [0.20 µmol/L (95% CI 0.027-0.376), p = 0.024] and postprandial state [AUC 40.71 (13.22-68.21), p = 0.005] and in faeces [ratio 1.5 (1.03-2.19); p = 0.035].
    2 context sentences
    Summary · context
    A total of 57 type 2 diabetes patients (mean ± SD age, 62.8 ± 6.9 years; BMI, 31.8 ± 4.1 kg/m2 ; HbA1c, 7.3% ± 0.6%), treated with metformin and/or sulfonylureas, were included in this 12-week randomized, placebo-controlled, double-blind, single-centre trial between July 2013 and August 2…
    Summary · context
    Patients received the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebo for 12 weeks.

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

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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