Pilot Study with Treatment of Short Bowel Syndrome Patients with dipeptidyl-peptidase 4 inhibitor, Sitagliptin (Januvia®)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001941-25-DK

Enrollment

Registered

2014-10-24

Start date

2014-12-16

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Bowel Syndrome with intestinal failure (SBS IF) MedDRA version: 17.1 Level: LLT Classification code 10022683 Term: Intestinal malabsorption System Organ Class: 100000004856 MedDRA version: 17.1 Level: LLT Classification code 10036430 Term: Post surgical malabsorption NOS System Organ Class: 100000004856 MedDRA ve

Interventions

Trade Name: Januvia Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sitagliptin Other descriptive name: SITAGLIPTIN Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with intestinal failure and short bowel syndrome and colon in continuation and function and fecal output = 1,5 kg Age 18 to 90 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Pregnant, disabled and patients with short bowel syndrome and stomi.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the trial is to assessthe therapeutic effect of the di-peptidyl-peptidase 4 inhibitor, Sitagliptin (Januvia®) for SBS patients with colon in function. The efficacy is assessed through the ability of sitagliptin (Januvia®) to increase intestinal absorption, reduce diarrhea and the need for hyperphagia. ; Secondary Objective: To test possible biomarkers for determination of intestinal adaptation, p-citrulline, p-paracetamol absorptions test are performed. ;Primary end point(s): Faecal weight/diarrhea;Timepoint(s) of evaluation of this end point: Before and at the end of 8 weeks of treatment with Januvia	—

Measure

Time frame

Main Objective: The objective of the trial is to assessthe therapeutic effect of the di-peptidyl-peptidase 4 inhibitor, Sitagliptin (Januvia®) for SBS patients with colon in function. The efficacy is assessed through the ability of sitagliptin (Januvia®) to increase intestinal absorption, reduce diarrhea and the need for hyperphagia. ; Secondary Objective: To test possible biomarkers for determination of intestinal adaptation, p-citrulline, p-paracetamol absorptions test are performed. ;Primary end point(s): Faecal weight/diarrhea;Timepoint(s) of evaluation of this end point: Before and at the end of 8 weeks of treatment with Januvia

—

Secondary

Measure	Time frame
Secondary end point(s): Change in: urinary volume oral intake parenteral volume support Fluid composite effect Body weight Body composition (DEXA) Mesenteric blood flow ;Timepoint(s) of evaluation of this end point: Before and at the end of 8 weeks of treatment with Januvia	—

Countries

Denmark

Contacts

Public ContactPalle Bekker Jeppesen

Rigshospitalet, 2121

bekker@dadlnet.dk+4520481323

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026