DRUG
teduglutide 0.05 mg/kg/d
0.05 mg/kg/d subcutaneous injection
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
Status
Completed
Phase
Phase 3
Enrollment
65
Locations
21
Results
Posted
Publications
3
Study summary
What the protocol is testing.
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
Full detailed description
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF). This multicenter, double-blind, international, Phase III trial will have a treatment period of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or do not enter into the long-term safety extension protocol CL0600-010.
Interventions
Treatment arms and agents.
DRUG
teduglutide 0.10 mg/kg/d
0.10 mg/kg/d subcutaneous injection
Timeline
From registration to results.
First posted
Sep 15, 2005
Study start
Jan 10, 2005
Primary completion
Jan 24, 2008
Study completion
Jan 24, 2008
Results posted
Apr 23, 2013
Registry updated
Jun 2, 2021
Outcomes
What the study measures.
Primary outcomes
Number of Subjects Achieving a 20% Reduction at Week 28
Time frame · 28 weeks
For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use.
Secondary outcomes
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use
Time frame · 6 months
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study. Subjects who meet all of the following criteria can be enrolled in this study: * Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed * Completion of protocol CL0600-004 (NCT00081458) Exclusion Criteria: * History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state * History of alcohol or drug abuse (within previous year) * Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit * Pregnant or lactating women * Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results
Study locations
21 registered sites.
Belgium · Canada · Denmark · France · Netherlands · Poland · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Albany Medical Center
Albany, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennsylvania - Penn Nursing
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Hôpital Erasme
Brussels, Belgium
St. Paul's Hospital
Vancouver, British Columbia, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Rigshospitalet
Copenhagen, Denmark
Hôpital Huriez
Lille, France
Hôpital de la Croix-Rousse
Lyon, France
Hôpital Lariboisière
Paris, France
Academic Medical Center, Department of Endocrinology & Metabolism
Amsterdam, Netherlands
Pracownia Żywienia
Olsztyn, Poland
Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
Warsaw, Poland
St. Mark's Hospital
Harrow, United Kingdom
Publications
Results and literature.
PMID 21317170 ↗Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):902-14. doi: 10.1136/gut.2010.218271. Epub 2011 Feb 11.PMID 23333663 ↗O'Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013 Jul;11(7):815-23.e1-3. doi: 10.1016/j.cgh.2012.12.029. Epub 2013 Jan 17.PMID 24134154 ↗Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17.
Related trials
More studies on Teduglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
Takeda · Short Bowel Syndrome
Phase 3
Recruiting
13
2026-06
Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
International Centre for Diarrhoeal Disease Research, Bangladesh · Environmental Enteric Dysfunction
Phase 2
Not yet recruiting
55
2026-04
A Study of Teduglutide in Japanese People With Short Bowel Syndrome
Takeda · Short Bowel Syndrome
Not applicable
Active, not recruiting
250
2026-04
A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
Takeda · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
12
2026-03
TED_ORG: Study on Short Bowel Syndrome
Meyer Children's Hospital IRCCS · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
50
2026-02
A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)
Takeda · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
600
2026-01
Registry for Participants With Short Bowel Syndrome
Shire · Short Bowel Syndrome
Not applicable
Active, not recruiting
1,806
2025-10
Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients
Assistance Publique - Hôpitaux de Paris · Short Bowel Syndrome
Phase 4
Completed
25
2025-09
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.