A randomized, double-blind, placebo-controlled, multiple-dose, parallel-group clinical trial to assess the effects of teduglutide on gastric emptying of liquids in healthy subjects.

Berg JK, Kim EH, Li B, Joelsson B, Youssef NN

BMC gastroenterology12 Feb 2014Cited by 13 (Europe PMC)

PMID24517114PMCIDPMC3928318DOI10.1186/1471-230x-14-25PepBankPUB-24517114

Summary

BackgroundTeduglutide, a recombinant analog of human glucagon-like peptide (GLP)-2, is a novel therapy recently approved for the treatment of adult patients with short bowel syndrome who are dependent on parenteral support. Previous studies assessing the effect of GLP-2 on gastric emptying in humans have yielded inconsistent results, with some studies showing no effect and others documenting a GLP-2-dependent delay in gastric emptying. The primary objective of this study was to assess the effect of teduglutide on gastric emptying of liquids in healthy subjects, as measured by the pharmacokinetics of acetaminophen.MethodsThis double-blind, parallel-group, single-center study enrolled and randomized 36 healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the morning. Gastric emptying of a mixed nutrient liquid meal was assessed by measuring acetaminophen levels predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, and 14 hours after administration of 1000 mg acetaminophen on Days 0 and 10. The primary study endpoint was a pharmacokinetic analysis of acetaminophen absorption in subjects receiving teduglutide or placebo.ResultsNo significant differences in gastric emptying of liquids (acetaminophen area under the concentration [AUC] vs time curve from time 0 to the last measurable concentration, AUC extrapolated to infinity, maximum concentration [Cmax], and time to Cmax) were observed on Day 10 in subjects receiving teduglutide 4 mg versus subjects receiving placebo. There were no serious adverse events (AEs), deaths, or discontinuations due to an AE reported during the study.ConclusionsTeduglutide 4 mg/day for 10 days does not affect gastric emptying of liquids in healthy subjects as measured by acetaminophen pharmacokinetics. No unexpected safety signals were observed.Trial registrationThis study was registered at ClinicalTrials.gov, identifier NCT01209351.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

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

01HumanRandomized controlled trialEfficacy outcome
In healthy subjects, teduglutide did not significantly change acetaminophen AUC to the last measurable concentration versus placebo on Day 10.
In plain wordsIn healthy subjects, acetaminophen exposure to the last measurement did not differ significantly between teduglutide and placebo.
Peptide
Teduglutide
Outcome
No significant changeAcetaminophen AUC to last measurable concentration
Study
n = 36
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal motility · Gastrointestinal
Studied dose
4 mg once daily · subcutaneous · 10 daysAs given in this study (human).
Source sentences
Summary
No significant differences in gastric emptying of liquids (acetaminophen area under the concentration [AUC] vs time curve from time 0 to the last measurable concentration, AUC extrapolated to infinity, maximum concentration [Cmax], and time to Cmax) were observed on Day 10 in subjects receiving teduglutide 4 mg versus subjects receiving placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary study endpoint was a pharmacokinetic analysis of acetaminophen absorption in subjects receiving teduglutide or placebo.
Summary · context
This double-blind, parallel-group, single-center study enrolled and randomized 36 healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the morning.
Show in the study text Report a problemFND-2451711401
02HumanRandomized controlled trialEfficacy outcome
In healthy subjects, teduglutide did not significantly change acetaminophen AUC extrapolated to infinity versus placebo on Day 10.
In plain wordsIn healthy subjects, estimated total acetaminophen exposure did not differ significantly between teduglutide and placebo.
Peptide
Teduglutide
Outcome
No significant changeAcetaminophen AUC extrapolated to infinity
Study
n = 36
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal motility · Gastrointestinal
Studied dose
4 mg once daily · subcutaneous · 10 daysAs given in this study (human).
Source sentences
Summary
No significant differences in gastric emptying of liquids (acetaminophen area under the concentration [AUC] vs time curve from time 0 to the last measurable concentration, AUC extrapolated to infinity, maximum concentration [Cmax], and time to Cmax) were observed on Day 10 in subjects receiving teduglutide 4 mg versus subjects receiving placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary study endpoint was a pharmacokinetic analysis of acetaminophen absorption in subjects receiving teduglutide or placebo.
Summary · context
This double-blind, parallel-group, single-center study enrolled and randomized 36 healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the morning.
Show in the study text Report a problemFND-2451711402
03HumanRandomized controlled trialEfficacy outcome
In healthy subjects, teduglutide did not significantly change acetaminophen maximum concentration versus placebo on Day 10.
In plain wordsIn healthy subjects, peak acetaminophen levels did not differ significantly between teduglutide and placebo.
Peptide
Teduglutide
Outcome
No significant changeAcetaminophen maximum concentration
Study
n = 36
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal motility · Gastrointestinal
Studied dose
4 mg once daily · subcutaneous · 10 daysAs given in this study (human).
Source sentences
Summary
No significant differences in gastric emptying of liquids (acetaminophen area under the concentration [AUC] vs time curve from time 0 to the last measurable concentration, AUC extrapolated to infinity, maximum concentration [Cmax], and time to Cmax) were observed on Day 10 in subjects receiving teduglutide 4 mg versus subjects receiving placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary study endpoint was a pharmacokinetic analysis of acetaminophen absorption in subjects receiving teduglutide or placebo.
Summary · context
This double-blind, parallel-group, single-center study enrolled and randomized 36 healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the morning.
Show in the study text Report a problemFND-2451711403
04HumanRandomized controlled trialEfficacy outcome
In healthy subjects, teduglutide did not significantly change acetaminophen time to maximum concentration versus placebo on Day 10.
In plain wordsIn healthy subjects, time to peak acetaminophen levels did not differ significantly between teduglutide and placebo.
Peptide
Teduglutide
Outcome
No significant changeAcetaminophen time to maximum concentration
Study
n = 36
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal motility · Gastrointestinal
Studied dose
4 mg once daily · subcutaneous · 10 daysAs given in this study (human).
Source sentences
Summary
No significant differences in gastric emptying of liquids (acetaminophen area under the concentration [AUC] vs time curve from time 0 to the last measurable concentration, AUC extrapolated to infinity, maximum concentration [Cmax], and time to Cmax) were observed on Day 10 in subjects receiving teduglutide 4 mg versus subjects receiving placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary study endpoint was a pharmacokinetic analysis of acetaminophen absorption in subjects receiving teduglutide or placebo.
Summary · context
This double-blind, parallel-group, single-center study enrolled and randomized 36 healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the morning.
Show in the study text Report a problemFND-2451711404
05HumanNon-randomized trialSafety outcome
In healthy subjects, no serious adverse events occurred during the study, including among teduglutide recipients.
In plain wordsIn healthy subjects, no serious adverse events occurred during the study, including among teduglutide recipients.
Peptide
Teduglutide
Outcome
Not applicableSerious adverse events
Study
n = 23
Outcome group
Adverse events · Whole body
Studied dose
4 mg once daily · subcutaneous · 10 daysAs given in this study (human).
Source sentences
Summary
There were no serious adverse events (AEs), deaths, or discontinuations due to an AE reported during the study.
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, parallel-group, single-center study enrolled and randomized 36 healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the morning.
Show in the study text Report a problemFND-2451711405
06HumanNon-randomized trialSafety outcome
In healthy subjects, no deaths occurred during the study, including among teduglutide recipients.
In plain wordsIn healthy subjects, no deaths occurred during the study, including among teduglutide recipients.
Peptide
Teduglutide
Outcome
Not applicableDeaths
Study
n = 23
Outcome group
Mortality · Whole body
Studied dose
4 mg once daily · subcutaneous · 10 daysAs given in this study (human).
Source sentences
Summary
There were no serious adverse events (AEs), deaths, or discontinuations due to an AE reported during the study.
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, parallel-group, single-center study enrolled and randomized 36 healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the morning.
Show in the study text Report a problemFND-2451711406
07HumanNon-randomized trialSafety outcome
In healthy subjects, no discontinuations due to adverse events occurred during the study, including among teduglutide recipients.
In plain wordsIn healthy subjects, no discontinuations due to adverse events occurred during the study, including among teduglutide recipients.
Peptide
Teduglutide
Outcome
Not applicableDiscontinuations due to adverse events
Study
n = 23
Outcome group
Adverse events · Whole body
Studied dose
4 mg once daily · subcutaneous · 10 daysAs given in this study (human).
Source sentences
Summary
There were no serious adverse events (AEs), deaths, or discontinuations due to an AE reported during the study.
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, parallel-group, single-center study enrolled and randomized 36 healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the morning.
Show in the study text Report a problemFND-2451711407

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 1NCT01209351

Effect of Teduglutide on Gastric Emptying in Healthy Subjects

Shiren = 3628 Sept 2010 to 8 Nov 2010

Healthy Volunteers

Trial page ClinicalTrials.govUpdated 4 Jun 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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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