iraglutide to Short Bowel Syndrome, a cross-over study

Phase 1

• Conditions: Short bowel syndrome (SBS) is a clinical situation with reduced absorptive mucosal surface due to extensive surgical resection. SBS leads to increased intestinal losses of fluids and electrolytes; restricted oral/enteral nutrition to reduce intestinal losses; disease-related hypophagia; lack of adaptive hyperphagia; accelerated gastrointestinal transit time; MedDRA version: 19.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-000825-35-DK
• Lead Sponsor: Rigshospitalet Blegdamsvej

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-08
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1.must give written informed consent before participation;
2.must be able to communicate with the investigator;
3.patients with SBS-IF or intestinal insufficiency with end-jejunostomy;
4.primary disease leading to SBS should be Mb. Crohn, volvulus, injury, mesenteric vascular disease or from benign origination;
5.age groups 18-90 years;
6.stable body weight (<5% weight deviance in past three month prior to screening);
7.minimum 1 liter of parental support (fluid and/or nutrition) per week or an ostomy output exceeding 1500 gram/day;
8.usual medicine must have been stable for at least four weeks and kept constant during whole study period;
9.must have an eGFR (by the MDRD formula7) >30 mL/min/1.73 m2
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 8

Exclusion Criteria

1.females who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods*;
2.systolic blood pressure > 180 mmHg;
3.type-1 diabetes mellitus;
4.chronic pancreatitis / previous acute pancreatitis;
5.known or suspected hypersensitivity to trial product(s) or related product;
6.treatment with oral glucocorticoids, calcineurin inhibitors, or DPP4 inhibitors which in the investigator’s opinion could interfere with glucose or lipid metabolism 90 days prior to screening;
7.cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial;
8.active inflammatory bowel disease or fistula;
9.cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months;
10.known with radiation enteritis or celiac disease; known or suspected abuse of alcohol or medicine;
11.impaired liver function (transaminases > two times upper reference levels);
12.clinically meaningful renal disease; subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2;
13.the receipt of any investigational product 90 days prior to this trial;
14.administration of glutamine or other growth factors for the past three months;
15.upon Investigator’s judgment

* Please view the Danish Health and Medicine Authority guideline on which type of contraception is considered safe in clinical trials on www.sundhedsstyrelsen.dk. Intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release and vaginal rings) are considered as adequate contraceptives. Sterilized or infertile subjects are exempt from the requirement to use contraception. In order to be considered sterilized or infertile, subjects must generally have undergone surgical sterilization (vasectomy/bilateral tubectomy, hysterectomy and bilateral ovariectomy) or be postmenopausal defined as 12 months or more with no menses prior to enrolment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified