Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS)

NCT03371862 | Withdrawn Phase 2

• 1 other identifier: 17IC3834
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study looking at the effect on Liraglutide in the reduction of parenteral support in patients with short bowel.

Conditions

Short Bowel Syndrome

Keywords

Liraglutide; Victoza

Outcome Measures

Primary Outcomes (1)

• Improvement in parenteral support

  Improvement of parenteral support on 20 weeks of Liraglutide

  20 weeks post start of drug

Secondary Outcomes (4)

• Improvement in quality of life

  20 weeks post start of drug

• Duration of response

  20 weeks

• Days/Nights not requiring PS

  20 weeks

• Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations

  20 weeks

Study Arms (1)

Test group

EXPERIMENTAL

Drug: Liraglutide Pen Injector [Victoza]

Interventions

Liraglutide Pen Injector [Victoza] DRUG

Pilot study of liraglutide in patients with short bowel.

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Short bowel (≤200cm) as a result of major intestinal resection (e.g. due to injury, volvulus, vascular disease, Crohn's disease).
• Jejunostomy patients only
• continuous months of parenteral support (PS) dependency prior to enrolment.
• PS required at least 3 times per week to meet their caloric, fluid or electrolyte needs due to on-going malabsorption.
• Stable PS for at least 4 consecutive weeks immediately prior to first dose of liraglutide. Stability is described as:
• Actual PS usage should match prescribed PS;
• Baseline 48-hour urine output is 1-2 L/24 hours.
• Body mass index ≥ 19.5 kg/m2.
• Adequate hepatic and renal function:
• Total bilirubin within the normal range;
• Alanine aminotransferase (ALT) ≤ 2.5x upper limit of normal;
• Serum creatinine ≤1.5x upper limit of normal.
• Stable dosage for \> 4 weeks, prior to baseline evaluations, of anti-motility and anti-diarrhoeal agents, H2 antagonists, proton pump inhibitors, bile sequestering agents and oral rehydration solutions.
• Female subjects must be on acceptable method of contraception for a minimum of 4 weeks prior to the start of the trial; Acceptable methods of contraception would be a barrier form of contraception, oral contraceptive pill, contraceptive injection or implant or intrauterine implanted device.

You may not qualify if:

• Patients \< 18 years of age
• Pregnancy (Female subjects who are not surgically sterile or post menopausal (defined as aged 55 years or older and/or at least 2 years have elapsed since the last menses) or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period. Acceptable methods of contraception would be a barrier form of contraception, oral contraceptive pill, contraceptive injection or implant or intrauterine implanted device.
• Active malignancy
• Previous malignancy within the past 5 years
• History of multiple endocrine neoplasia type 2 (MEN 2)
• Personal history or family history of medullary thyroid cancer
• Raised serum calcitonin (a biomarker for medullary thyroid cancer) at beginning of trial period
• History of cardiac failure
• Concurrent use of diuretics
• Previous history of pancreatitis
• Recent use of other incretin based therapy in the previous 3 months
• Concurrent use of octreotide
• Type 1 or Type 2 diabetes
• Alcohol or drug abuse in last year
• \> 4 hospitalisations related to short bowel or its treatment over the previous year

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

St Mark's Hospital

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Siddhartha Oke

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: December 13, 2017
• Study Start: October 20, 2017
• Primary Completion: August 6, 2020
• Study Completion: September 30, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

GB (1)