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Study · Non-randomized trial · n = 86 · 2012

5 results

Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure.

Jeppesen PB, Pertkiewicz M, Messing B, Iyer K, Seidner DL, O'keefe SJ, Forbes A, Heinze H, Joelsson B

Gastroenterology11 Sept 2012Cited by 348 (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: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

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

  1. 01HumanNon-randomized trialEfficacy outcome

    In SBS-IF patients, responders were more frequent with teduglutide (27/43, 63%) than placebo (13/43, 30%; P = .002).

    In plain wordsIn SBS-IF patients, teduglutide produced more parenteral support volume responders than placebo.

    Outcome
    IncreaseParenteral support volume responders
    Study

    n = 86

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Parenteral support · Gastrointestinal
    Studied dose
    0.05 mg/kg/d once daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Responders (>20% reduction in parenteral support volume at weeks 20 and 24)
    63%
    teduglutide 0.05 mg/kg/d, 27/43
    Responders (>20% reduction in parenteral support volume at weeks 20 and 24)
    30%
    placebo, 13/43

    Source sentences

    Summary
    There were significantly more responders in the teduglutide group (27/43 [63%]) than the placebo group (13/43 [30%]; P = .002).
    2 context sentences
    Summary · context
    The primary efficacy end point was number of responders (patients with >20% reduction in parenteral support volume from baseline at weeks 20 and 24).
    Summary · context
    We performed a 24-week study of patients with SBS-IF who were given subcutaneous teduglutide (0.05 mg/kg/d; n = 43) or placebo (n = 43) once daily.
  2. 02HumanNon-randomized trialEfficacy outcome

    In SBS-IF patients, a 1-day or greater weekly support reduction occurred in 21/39 (54%) with teduglutide versus 9/39 (23%) with placebo (P = .005).

    In plain wordsIn SBS-IF patients, more teduglutide recipients than placebo recipients reduced weekly support needs by at least one day.

    Outcome
    IncreasePatients with a 1-day or more weekly reduction in parenteral support
    Study

    n = 78

    Comparator
    Placebo
    Outcome group
    Parenteral support · Gastrointestinal
    Studied dose
    0.05 mg/kg/d once daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Patients with 1-day or more weekly reduction in parenteral support
    54%
    teduglutide group, 21/39
    Patients with 1-day or more weekly reduction in parenteral support
    23%
    placebo group, 9/39

    Source sentences

    Summary
    The percentage of patients with a 1-day or more reduction in the weekly need for parenteral support was greater in the teduglutide group (21/39 [54%]) than in the placebo group (9/39 [23%]; P = .005).
    1 context sentence
    Summary · context
    We performed a 24-week study of patients with SBS-IF who were given subcutaneous teduglutide (0.05 mg/kg/d; n = 43) or placebo (n = 43) once daily.
  3. 03HumanNon-randomized trialEfficacy outcome

    In SBS-IF patients, parenteral support volume fell by 4.4 ± 3.8 L/wk with teduglutide versus 2.3 ± 2.7 L/wk with placebo (P < .001).

    In plain wordsIn SBS-IF patients, teduglutide reduced parenteral support volume more than placebo at week 24.

    Outcome
    DecreaseParenteral support volume reduction at week 24
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Parenteral support · Gastrointestinal
    Studied dose
    0.05 mg/kg/d once daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Mean reduction in parenteral support volume at week 24
    4.4 L/wk
    teduglutide group, SD 3.8, baseline 12.9 ± 7.8 L/wk
    Mean reduction in parenteral support volume at week 24
    2.3 L/wk
    placebo group, SD 2.7, baseline 13.2 ± 7.4 L/wk

    Source sentences

    Summary
    At week 24, the mean reduction in parenteral support volume in the teduglutide group was 4.4 ± 3.8 L/wk (baseline 12.9 ± 7.8 L/wk) compared with 2.3 ± 2.7 L/wk (baseline 13.2 ± 7.4 L/wk) in the placebo group (P < .001).
    1 context sentence
    Summary · context
    We performed a 24-week study of patients with SBS-IF who were given subcutaneous teduglutide (0.05 mg/kg/d; n = 43) or placebo (n = 43) once daily.
  4. 04HumanNon-randomized trialEfficacy outcome

    In SBS-IF patients, teduglutide increased plasma citrulline concentrations, a biomarker of mucosal mass.

    In plain wordsIn SBS-IF patients, teduglutide increased blood citrulline levels, a marker of intestinal mucosal mass.

    Outcome
    IncreasePlasma citrulline concentration
    Study

    n: not reported in source

    Outcome group
    Intestinal adaptation · Gastrointestinal
    Studied dose
    0.05 mg/kg/d once daily · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Teduglutide increased plasma concentrations of citrulline, a biomarker of mucosal mass.
    1 context sentence
    Summary · context
    We performed a 24-week study of patients with SBS-IF who were given subcutaneous teduglutide (0.05 mg/kg/d; n = 43) or placebo (n = 43) once daily.
  5. 05HumanNon-randomized trialSafety outcome

    In SBS-IF patients, adverse events leading to discontinuation had a similar distribution with teduglutide (n = 2) and placebo (n = 3).

    In plain wordsIn SBS-IF patients, adverse events leading to discontinuation had a similar distribution with teduglutide and placebo.

    Outcome
    Direction not reportedTreatment-emergent adverse events leading to discontinuation
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.05 mg/kg/d once daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Patients with treatment-emergent adverse events leading to study discontinuation
    2 patients
    teduglutide group
    Patients with treatment-emergent adverse events leading to study discontinuation
    3 patients
    placebo group

    Source sentences

    Summary
    The distribution of treatment-emergent adverse events that led to study discontinuation was similar between patients given teduglutide (n = 2) and placebo (n = 3).
    1 context sentence
    Summary · context
    We performed a 24-week study of patients with SBS-IF who were given subcutaneous teduglutide (0.05 mg/kg/d; n = 43) or placebo (n = 43) once daily.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedEarly phase 1NCT04290429

Treatment of Patients With Teduglutide (GLP-2) for GVHD and Analysis of Paneth Cells of GVHD Patients

University of Freiburgn = 66 Dec 2017 to 6 Dec 2019

Graft Versus Host Disease

Trial pageClinicalTrials.govUpdated 29 Nov 2023
CompletedPhase 3Results postedNCT00798967

Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects

Shiren = 8625 Nov 2008 to 25 Jan 2011

Short Bowel Syndrome

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

Subjects

Terms as the source lists them.

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