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Study · Randomized controlled trial · 2015

5 results

Effect of Teduglutide, a Glucagon-like Peptide 2 Analog, on Citrulline Levels in Patients With Short Bowel Syndrome in Two Phase III Randomized Trials.

Seidner DL, Joly F, Youssef NN

Clinical and translational gastroenterology25 Jun 2015Cited by 30 (Europe PMC)

PMID26111125 (opens in a new tab)PMCIDPMC4816243 (opens in a new tab)DOI10.1038/ctg.2015.15 (opens in a new tab)PepBankPUB-26111125
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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-ND. 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 SBS patients in CL0600-004, citrulline increased by 10.9 μmol/L with teduglutide 0.05 mg/kg/day versus 2.0 μmol/L with placebo (P≤0.0001).

    In plain wordsIn SBS patients in CL0600-004, lower-dose teduglutide increased citrulline more than placebo at Week 24.

    Peptide
    Teduglutide
    Outcome
    IncreaseCitrulline change in CL0600-004 at lower dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Intestinal adaptation · Gastrointestinal
    Studied dose
    0.05 mg/kg/day · 24 weeksAs given in this study (human).

    Measurements

    Change in mean plasma citrulline, week 24 vs baseline
    10.9 μmol/L
    teduglutide 0.05 mg/kg/day, CL0600-004
    Change in mean plasma citrulline, week 24 vs baseline
    2 μmol/L
    placebo, CL0600-004
    P value
    ≤ 0.0001
    teduglutide vs placebo

    Source sentences

    Summary
    In both the CL0600-004 and CL0600-020 studies, change in mean plasma citrulline concentrations at Week 24 vs. baseline was significantly greater with teduglutide compared with placebo (10.9 (0.05-mg/kg/day dose) and 15.7 (0.10-mg/kg/day dose) vs. 2.0 μmol/L and 20.6 vs. 0.7 μmol/L, respectively, for…
    2 context sentences
    Summary · context
    This analysis assessed changes in plasma citrulline levels in patients with SBS in 2 phase III clinical studies of teduglutide.
    Summary · context
    Both teduglutide studies (0.05 or 0.10 mg/kg/day in CL0600-004 and 0.05 mg/kg/day in CL0600-020) were phase III, 24-week, double-blind, and placebo controlled.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In SBS patients in CL0600-004, citrulline increased by 15.7 μmol/L with teduglutide 0.10 mg/kg/day versus 2.0 μmol/L with placebo (P≤0.0001).

    In plain wordsIn SBS patients in CL0600-004, higher-dose teduglutide increased citrulline more than placebo at Week 24.

    Peptide
    Teduglutide
    Outcome
    IncreaseCitrulline change in CL0600-004 at higher dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Intestinal adaptation · Gastrointestinal
    Studied dose
    0.10 mg/kg/day · 24 weeksAs given in this study (human).

    Measurements

    Change in plasma citrulline at Week 24 vs baseline
    15.7 μmol/L
    teduglutide 0.10 mg/kg/day, CL0600-004
    Change in plasma citrulline at Week 24 vs baseline
    2 μmol/L
    placebo, CL0600-004

    Source sentences

    Summary
    In both the CL0600-004 and CL0600-020 studies, change in mean plasma citrulline concentrations at Week 24 vs. baseline was significantly greater with teduglutide compared with placebo (10.9 (0.05-mg/kg/day dose) and 15.7 (0.10-mg/kg/day dose) vs. 2.0 μmol/L and 20.6 vs. 0.7 μmol/L, respectively, for…
    2 context sentences
    Summary · context
    This analysis assessed changes in plasma citrulline levels in patients with SBS in 2 phase III clinical studies of teduglutide.
    Summary · context
    Both teduglutide studies (0.05 or 0.10 mg/kg/day in CL0600-004 and 0.05 mg/kg/day in CL0600-020) were phase III, 24-week, double-blind, and placebo controlled.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In SBS patients in CL0600-020, citrulline increased by 20.6 μmol/L with teduglutide versus 0.7 μmol/L with placebo at Week 24 (P≤0.0001).

    In plain wordsIn SBS patients in CL0600-020, teduglutide increased citrulline more than placebo at Week 24.

    Peptide
    Teduglutide
    Outcome
    IncreaseCitrulline change in CL0600-020
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Intestinal adaptation · Gastrointestinal
    Studied dose
    0.05 mg/kg/day · 24 weeksAs given in this study (human).

    Measurements

    Change in plasma citrulline at Week 24 vs baseline
    20.6 μmol/L
    teduglutide 0.05 mg/kg/day, CL0600-020
    Change in plasma citrulline at Week 24 vs baseline
    0.7 μmol/L
    placebo, CL0600-020

    Source sentences

    Summary
    In both the CL0600-004 and CL0600-020 studies, change in mean plasma citrulline concentrations at Week 24 vs. baseline was significantly greater with teduglutide compared with placebo (10.9 (0.05-mg/kg/day dose) and 15.7 (0.10-mg/kg/day dose) vs. 2.0 μmol/L and 20.6 vs. 0.7 μmol/L, respectively, for…
    2 context sentences
    Summary · context
    This analysis assessed changes in plasma citrulline levels in patients with SBS in 2 phase III clinical studies of teduglutide.
    Summary · context
    Both teduglutide studies (0.05 or 0.10 mg/kg/day in CL0600-004 and 0.05 mg/kg/day in CL0600-020) were phase III, 24-week, double-blind, and placebo controlled.
  4. 04HumanNon-randomized trialEfficacy outcome

    In patients with short bowel syndrome, teduglutide treatment was associated with reduced parenteral support volume requirements from baseline.

    In plain wordsIn patients with short bowel syndrome, teduglutide treatment was linked to reduced parenteral support volume from baseline.

    Peptide
    Teduglutide
    Outcome
    DecreaseParenteral support volume
    Study

    n: not reported in source

    Outcome group
    Parenteral support · Gastrointestinal
    Studied dose
    0.05 or 0.10 mg/kg/day · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Teduglutide treatment was associated with reductions from baseline in PS (parenteral support) volume requirements; however, a significant correlation between PS reduction and increase in plasma citrulline at Week 24 was observed in only one out of the three teduglutide treatment groups.
    2 context sentences
    Summary · context
    This analysis assessed changes in plasma citrulline levels in patients with SBS in 2 phase III clinical studies of teduglutide.
    Summary · context
    Both teduglutide studies (0.05 or 0.10 mg/kg/day in CL0600-004 and 0.05 mg/kg/day in CL0600-020) were phase III, 24-week, double-blind, and placebo controlled.
  5. 05HumanObservational studyOther

    In SBS patients, PS reduction correlated significantly with citrulline increase at Week 24 in only one of three teduglutide groups.

    In plain wordsIn SBS patients, support reduction and citrulline increase were significantly linked in only one of three teduglutide groups.

    Peptide
    Teduglutide
    Outcome
    MixedCorrelation between PS reduction and citrulline increase
    Study

    n: not reported in source

    Outcome group
    Intestinal adaptation · Gastrointestinal
    Studied dose
    0.05 or 0.10 mg/kg/day · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Teduglutide treatment was associated with reductions from baseline in PS (parenteral support) volume requirements; however, a significant correlation between PS reduction and increase in plasma citrulline at Week 24 was observed in only one out of the three teduglutide treatment groups.
    2 context sentences
    Summary · context
    This analysis assessed changes in plasma citrulline levels in patients with SBS in 2 phase III clinical studies of teduglutide.
    Summary · context
    Both teduglutide studies (0.05 or 0.10 mg/kg/day in CL0600-004 and 0.05 mg/kg/day in CL0600-020) were phase III, 24-week, double-blind, and placebo controlled.

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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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

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Terms as the source lists them.

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