Clinical trial of patients with type 2 diabetes and obesity randomly allocated to be implanted with an intestinal liner device with or without standard diabetes liraglutide medical therapy or liraglutide alone.

• Conditions: Combined Type 2 diabetes mellitus and obesity.; MedDRA version: 14.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2012-004988-42-GB
• Lead Sponsor: Sandwell and West Birmingham Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-04
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Patients will be eligible to be included in this randomised clinical trial if they meet the following inclusion criteria: 1. participation in ABCD Nationwide Liraglutide Audit with data for at least 6 months, 2. HbA1c =7.5% after at least 6 months’ Liraglutide treatment, 3. BMI =35 Kg/m2 (=30 Kg/m2 for Asian origin patients), 4. stable weight and HbA1c in preceding 3 months (<3 Kg reduction in weight and <0.3% reduction in HbA1c).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

Exclusion criteria will include the following: abnormal intestinal anatomy; contraindication to oesophago-gastroduoenoscopy; previous bariatric surgery or bowel surgery; active infection or CRP >10; anticoagulation therapy; coagulopathy INR >1.3; eGFR <30; known portal hypertension; previous pancreatitis or amylase > 3 times the upper limit of normal; uncontrolled cardiovascular disease; lactating or pregnant females. Patients taking aspirin with active ischaemic heart disease or cerebrovascular disease or those in whom aspirin treatment should continue. Patients taking regular aspirin will need to discontinue it for the duration of the Endobarrier implantation if randomised to that arm and so for those in whom it is taken for primary prevention, the potential risks and benefits of deciding to discontinue aspirin will be weighed up by the clinician concerned in consultation with the patient.

Study & Design

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