Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

What Was Tested

This registered phase 3 trial tested Teduglutide (GLP-2 analog).

It had three arms (groups): placebo (placebo comparator), 2 (experimental) and 3 (experimental).

Placebo injectable subcutaneously daily into the thigh or abdomen.

The registry classes the interventions as drug.

More on the Plan

Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation, and maintenance of cells lining the gastrointestinal tract.

Who Took Part

84 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and women, aged 18 years of age or older at the time of signing the informed consent form (ICF). SBS as a result of major intestinal resection resulting in at least 12 months intravenous feeding. Body weight must be less than 90 kg. Body mass index (BMI) 18 to 27 kg/m2. Adequate hepatic and renal function.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: history of alcohol or drug abuse (within previous year); participation in a clinical study within 30 days prior to signing the icf, or concurrent participation in any clinical study; previous use of teduglutide (alx-0600).

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Teduglutide (GLP-2 analog) group and the comparison group should start out alike.

The Teduglutide (GLP-2 analog) group and the comparison group ran side by side rather than switching.

As a double-blind Teduglutide (GLP-2 analog) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2004-05-25 with completion listed for 2007-07-06.

It ran at 32 sites in United States (14), Canada (4), France (4), Germany (3), Poland (2) and United Kingdom (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teduglutide (GLP-2 analog) in 84 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.