GLIDE: Gastric band and Liraglutide Intervention in Diabetes Evolution

INTERVENTION: Following laparoscopic adjustable gastric band (LAGB), patients will be randomised to receive liraglutide or placebo. Randomisation will be carried out by a computer generated randomisation package. Patients will be stratified by duration of diabetes, BMI, centre and use of insulin through minimisation with a random component to ensure balance between treatment arms. Patients will be assigned to either injectable Liraglutide treatment or injectable placebo. Liraglutide (or placebo) will be titrated as recommended to the maximum tolerated dose or 1.8mg. Dose escalation will be based on tolerability of previous dose. Participants will inject liraglutide/placebo daily for 6 months (including titration phase). Participants will then be followed up for a further 6 months after they have stopped taking the intervention. CONDITION: Specialty: Diabetes, Primary sub‐specialty: Type 2; UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus ; Nutritional, Metabolic, Endocrine ; Diabetes mellitus PRIMARY OUTCOME: Difference in glycated haemoglobin (HbA1C) is measured using a glycated haemoglobin blood test at baseline and 6 months. SECONDARY OUTCOME: 1. Difference in glycated Haemoglobin (HbA1c) is measured using a glycated haemoglobin blood test at baseline and 12 months; 2. Percentage of patients achieving diabetes remission comprising a HbA1c level of less than 6.5% and off all diabetes medications is measured by HbA1c blood test and clinical review/patient interview at months 3, 6, 9 and 12.; 3. Homeostatic Model Assessment of Insulin Resistance (HOMA‐IR) is measured using fasting glucose, insulin and c‐peptide blood tests at baseline, 6 and 12 months ; 4. Number of reported hypoglycaemic episodes are measured by clinical interview at months 3, 6, 9 and 12.; 5. Anthropometric measures and body composition (height, weight, waist and neck circumference, BMI and Bioimpedance (Body Fat via Bioelectrical Impedance)) are measured at baseline, 3, 6 and 12 months; 3. Physical activity levels are recorded using the General Physical Activity Questionnaire at baseline, 6 and 12 months; 4. Cardiovascular disease risk factors (Systolic and Diastolic BP; total cholesterol, HDL‐cholesterol, LDL‐cholesterol and Triglyceride) are measured using a sphygmomanometer and blood testing at baseline, 3, 6 and 12 months; 5. Quality of life is measured using the Impact of Weight on Quality of Life‐Lite (IWQoL‐Lite) Questionnaire, at baseline, 3, 6 and 12 months; 6. Depression, anxiety and emotional distress is measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 6 and 12 months.; 6. Adverse event rates recorded by clinical interview at baseline, 3, 6 and 12 months INCLUSION CRITERIA: 1. Adult patients with type 2 diabetes 2. HbA1c =6.5% and <11% at screening 3. Age 18‐70 years 4. Patients with a BMI equal to or above 30kg/m2 (or 27kg/m2 and of Asian family origin) at screening 5. Patients undergoing LAGB based on NICE criteria and multidisciplinary assessment 6. Written informed consent to participate