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Study · Randomized controlled trial · 2010

7 results

Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn's disease.

Buchman AL, Katz S, Fang JC, Bernstein CN, Abou-Assi SG

Inflammatory bowel diseases1 Jun 2010Cited by 109 (Europe PMC)

PMID19821509 (opens in a new tab)DOI10.1002/ibd.21117 (opens in a new tab)PepBankPUB-19821509
Publisher pagePubMedAsk about this study
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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 study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In moderate-to-severe Crohn's disease, all teduglutide groups had numerically higher clinical response rates than placebo.

    In plain wordsIn patients with Crohn's disease, clinical response rates were numerically higher with teduglutide than placebo.

    Peptide
    Teduglutide
    Outcome
    IncreaseClinical response
    Study

    n: not reported in source

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Disease Activity · Gastrointestinal
    Studied dose
    0.05, 0.10, or 0.20 mg/kg daily · subcutaneous · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    There were numerically higher response and remission rates in all teduglutide-treated groups as compared with placebo, although
    1 context sentence
    Summary · context
    Subjects with moderate-to-severe CD were randomized 1:1:1:1 to placebo or 1 of 3 doses of teduglutide (0.05, 0.10, or 0.20 mg/kg daily) delivered as a daily subcutaneous injection for 8 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Crohn's disease, the highest teduglutide dose had 44% response versus 32% with placebo, with improvement reported as early as week 2.

    In plain wordsIn Crohn's disease, response was 44% with the highest teduglutide dose versus 32% with placebo.

    Peptide
    Teduglutide
    Outcome
    IncreaseClinical response in highest-dose group
    Study

    n: not reported in source

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Disease Activity · Gastrointestinal
    Studied dose
    0.2 mg/kg/d · subcutaneousAs given in this study (human).

    Measurements

    Clinical response
    44%
    highest dose
    Clinical response
    32%
    placebo

    Source sentences

    Summary
    although the percentage of subjects who achieved a clinical response or remission was more substantial, and seen as early as week 2 of treatment in the highest dose (0.2 mg/kg/d) group (44% response and 32% remission versus 32% response and 20% remission in the placebo group).
    1 context sentence
    Summary · context
    Subjects with moderate-to-severe CD were randomized 1:1:1:1 to placebo or 1 of 3 doses of teduglutide (0.05, 0.10, or 0.20 mg/kg daily) delivered as a daily subcutaneous injection for 8 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In moderate-to-severe Crohn's disease, all teduglutide groups had numerically higher remission rates than placebo.

    In plain wordsIn patients with Crohn's disease, remission rates were numerically higher with teduglutide than placebo.

    Peptide
    Teduglutide
    Outcome
    IncreaseClinical remission
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Disease Activity · Gastrointestinal
    Studied dose
    0.05, 0.10, or 0.20 mg/kg daily · subcutaneous · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    There were numerically higher response and remission rates in all teduglutide-treated groups as compared with placebo, although
    1 context sentence
    Summary · context
    Subjects with moderate-to-severe CD were randomized 1:1:1:1 to placebo or 1 of 3 doses of teduglutide (0.05, 0.10, or 0.20 mg/kg daily) delivered as a daily subcutaneous injection for 8 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Crohn's disease, the highest teduglutide dose had 32% remission versus 20% with placebo, with improvement reported as early as week 2.

    In plain wordsIn Crohn's disease, remission was 32% with the highest teduglutide dose versus 20% with placebo.

    Peptide
    Teduglutide
    Outcome
    IncreaseClinical remission in highest-dose group
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Disease Activity · Gastrointestinal
    Studied dose
    0.2 mg/kg/d · subcutaneousAs given in this study (human).

    Measurements

    Clinical remission
    32%
    highest dose
    Clinical remission
    20%
    placebo

    Source sentences

    Summary
    although the percentage of subjects who achieved a clinical response or remission was more substantial, and seen as early as week 2 of treatment in the highest dose (0.2 mg/kg/d) group (44% response and 32% remission versus 32% response and 20% remission in the placebo group).
    1 context sentence
    Summary · context
    Subjects with moderate-to-severe CD were randomized 1:1:1:1 to placebo or 1 of 3 doses of teduglutide (0.05, 0.10, or 0.20 mg/kg daily) delivered as a daily subcutaneous injection for 8 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Crohn's disease, plasma citrulline increased substantially in all teduglutide groups versus placebo at week 8.

    In plain wordsIn patients with Crohn's disease, teduglutide increased plasma citrulline versus placebo at week 8.

    Peptide
    Teduglutide
    Outcome
    IncreasePlasma citrulline at week 8
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    0.05, 0.10, or 0.20 mg/kg daily · subcutaneous · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    Plasma citrulline was similar across groups at baseline, but increased substantially over time in all teduglutide groups when compared with placebo at week 8.
    1 context sentence
    Summary · context
    Subjects with moderate-to-severe CD were randomized 1:1:1:1 to placebo or 1 of 3 doses of teduglutide (0.05, 0.10, or 0.20 mg/kg daily) delivered as a daily subcutaneous injection for 8 weeks.
  6. 06HumanRandomized controlled trialSafety outcome

    In Crohn's disease, adverse events did not differ between teduglutide groups and placebo.

    In plain wordsIn patients with Crohn's disease, adverse events did not differ between teduglutide and placebo.

    Peptide
    Teduglutide
    Outcome
    No significant changeAdverse events
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    Adverse events were not different between placebo and active treatment groups.
    1 context sentence
    Summary · context
    Subjects with moderate-to-severe CD were randomized 1:1:1:1 to placebo or 1 of 3 doses of teduglutide (0.05, 0.10, or 0.20 mg/kg daily) delivered as a daily subcutaneous injection for 8 weeks.
  7. 07HumanNon-randomized trialEfficacy outcome

    Among higher-dose Crohn's disease nonremitters, 50% achieved remission during prolonged open-label teduglutide treatment.

    In plain wordsAmong higher-dose Crohn's disease patients without remission, 50% achieved remission during further open-label teduglutide treatment.

    Peptide
    Teduglutide
    Outcome
    Not applicableOpen-label remission
    Study

    n: not reported in source

    Outcome group
    Disease Activity · Gastrointestinal
    Studied dose
    0.10 mg/kg/d · subcutaneousAs given in this study (human).

    Measurements

    Remission
    50%
    higher-dose nonremitters during open-label treatment

    Source sentences

    Summary
    Of subjects who had not achieved remission during the 8-week placebo-controlled phase in the higher-dose group, 50% achieved remission during the more prolonged, open-label treatment phase.
    2 context sentences
    Summary · context
    At week 8 there was an optional 12-week open-label period of treatment with teduglutide 0.10 mg/kg/d.
    Summary · context
    Subjects with moderate-to-severe CD were randomized 1:1:1:1 to placebo or 1 of 3 doses of teduglutide (0.05, 0.10, or 0.20 mg/kg daily) delivered as a daily subcutaneous injection for 8 weeks.

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

CompletedPhase 2NCT00308438

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

Shiren = 671 Mar 2004 to 1 Jun 2006

Crohn's Disease

Trial pageClinicalTrials.govUpdated 14 May 2021
CompletedPhase 2NCT00072839

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

Shiren = 10012 Nov 2003 to 28 Jul 2005

Crohn's Disease

Trial pageClinicalTrials.govUpdated 25 May 2021

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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