Combined Type 2 diabetes mellitus and obesity. MedDRA version: 14.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza
Product Name: Liraglutide
Product Code: n/a
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Liraglutide
Concentration unit: mg/ml milligram(s)/mi
Sponsors
Sandwell and West Birmingham Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In an NHS setting, what is the impact of Endobarrier (a device inserted into the intestine to coat its inside and prevent absorption of food where it is sited) alone versus combined Endobarrier-Liraglutide therapy (a daily injectable medication for type 2 diabetes) in patients with obesity and type 2 diabetes mellitus who have not yet met national treatment targets despite at least 6 months of Liraglutide treatment alone?;Secondary Objective: What are the mechanisms of action by which Endobarrier exerts its effect of weight reduction and improved diabetes control?;Primary end point(s): The primary outcome measure for the study will be participant weight and HbA1c in the two Endobarrier-treated groups at the last follow-up visit, which will be at 12 months after Endobarrier removal (equivalent to 12 months after Endobarrier implantation).;Timepoint(s) of evaluation of this end point: 12 months post-explant of the Endobarrier device, which will usually be inserted for 1 year. Therefore 24 months from implant of the Endobarrier. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are: fasting insulin, glucose, c-peptide to calculate HOMA-IR and bile acids; hepatic and pancreatic triacylglycerol stores; quality of life scores; gut microbiota and faecal calprotectin changes over time in Endobarrier-treated patients.;Timepoint(s) of evaluation of this end point: Insulin resistance (HOMA-IR) to be evaluated at days 2, 4 and 7 post Endobarrier placement and days 2,4 and 7 post Endobarrier removal and compared to baseline. Hepatic and pancreatic triacylglycerol stores compared at 3 months post Endobarrier placement to baseline. | — |
Countries
United Kingdom
Contacts
Public ContactDr Bob Ryder
City Hospital, Birmingham
Outcome results
None listed