This trial will investigate the effects of the study treatment arms (gastric band + placebo
Conditions
Interventions
Trade Name: Victoza 6 mg/ml solution for injection in pre-filled pen
Product Name: Liraglutide
Pharmaceutical Form: Solution for injection
INN or Propos
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients with type 2 diabetes and a BMI equal or above 35 kg/m2 who are undergoing laparoscopic adjustable gastric band (LAGB) surgery at our centre based on NICE criteria and multidisciplinary assessment will be included.Type 2 diabates patients undergoing a diet and exercise programme and taking metformin and any sulfonylurea medication. A full medical history (including medications) and medical examination will be carried out at enrolement. 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 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Patients who refuse or are unable to have injectable treatment post operatively 2. Patients with disability preventing use of treatment 3. Patients who cannot give consent 4. Patients with known delayed gastric emptying 5. Patients taking any medications that may interact with the trial medication 6. Any contraindications stated in the BNF to liraglutide use (inflammatory bowel disease, ketosis, diabetic gastroparesis (based on clinical assessment), DPP-4 inhibitors, pregnancy and breast feeding, renal impairment (eGFR11% 10.Pregnancy or breastfeeding or planning to become pregnant during the study period and women of childbearing age who are not using adequate contraceptive methods 11.personal or family history of theyroid cancer or multiple endocrine neoplasia 12.History of previous pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ; Primary end point(s): The primary outcome is the percentage of patients with diabetes resolution as defined by fasting blood glucose levels of <7mmol/L. ; Main Objective: The study will seek to address the following major questions regarding liraglutide combined with the gastric band: When compared with band alone, will the combination treatment result in greater - 1. diabetes resolution 2. weight loss and reduction in body fat 3. change in quality of life 4. reduction in cardiovascular risk | — |
Countries
United Kingdom
Outcome results
None listed