Type 2 Diabetes MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza 6 mg/ml solution for injection in pre-filled pen
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for inject
Sponsors
Guys and St Thomas NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients with type 2 diabetes diagnosed within the last 10 years 2. HbA1c =6.5% and =65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes (based on clinical history) 2. Patients who refuse or are unable to have injectable treatment post operatively 3. Patients with any disability preventing use of treatment 4. Patients with known delayed gastric emptying 5. Patients with a hypersensitivity to liraglutide or any of the excipients listed in the summary of product charateristics; or any limitation to liraglutide use (active at time of screening or likely to be recurrent and/or clinically significant in the future) as per the summary of product characteristics (for example: Inflammatory bowel disease, Diabetic Ketoacidosis, diabetic gastroparesis (based on clinical assessment), severe renal impairment (eGFR < 30mL/min/1.73m2), severe hepatic impairment, acute pancreatitis (persistent, severe abdominal pain) and congestive heart failure NYHA class IV) 6. Type 2 diabetes controlled purely through diet unless metformin is contraindicated or not tolerated 7. Pregnancy or breastfeeding or planning to become pregnant during the study period and women of childbearing age who are not using adequate contraceptive 8. Personal or family history of thyroid cancer or multiple endocrine neoplasia 9. History of previous pancreatitis 10. Administration of a GLP-1 agonist or DPP-IV inhibitor after surgery. 11. Patients who display insufficient understanding of the trial procedures following reasonable attempts by the investigator to provide information, at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 6 months (visit 5);Main Objective: To determine whether the addition of liraglutide to the gastric band results in improved glycaemic control;Primary end point(s): 1. The difference in change in HbA1C at 6 months from baseline (6 weeks post-surgery) between intervention and control groups. ; Secondary Objective: To determine whether the addition of liraglutide to the gastric band results in: • Greater improvement in insulin resistance • Greater rates of diabetes remission • Greater weight loss • Greater reduction in body fat • Greater improvement in quality of life • Greater improvement in markers of cardiovascular risk • Greater increase in physical activity levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Other diabetes outcomes •The difference in change in HbA1c at 12 months from baseline between intervention and control groups •Percentage of patients with remission of diabetes at 12 months defined as HbA1c <6.5% and off all diabetes medications. •HOMA-IR (index of insulin sensitivity) •Hypoglycaemic episodes 2. Anthropometric measures and body composition •Body weight •BMI •Waist circumference •Neck circumference •Bioimpedance (Body Fat via Bioelectrical Impedance) 3. Alterations in physical activity levels (GPAQ questionnaire) 4. Cardiovascular disease risk factors including •Systolic BP •Diastolic BP •total cholesterol •HDL-cholesterol •LDL-cholesterol •Triglyceride 5. Quality of life and psychological measures (IWQOL-Lite, EQ-5D-5L, HADS) 6. Adverse event rates ; Timepoint(s) of evaluation of this end point: Difference in change of HbA1C will be measured at 12 months (visit 7) All others will be measured at each visit | — |
Countries
United Kingdom
Contacts
Public ContactDr Barbara McGowan
Guy's and St Thomas' NHS Foundation Trust
Outcome results
None listed