GLIDE: Gastric band and Liraglutide Intervention in Diabetes Evolutio

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-005402-11-GB
• Lead Sponsor: Guys and St Thomas NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-18
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 58

Inclusion Criteria

1.Adult patients with type 2 diabetes diagnosed within the last 10 years
2.HbA1c =6.5% and <11% at or before screening
3.Age 18-70 years
4.Patients with a BMI equal to or above 30kg/m2 (or 27.5kg/m2 and of Asian family origin) and less than or equal to 50kg/m2 at screening
5.Patients undergoing LAGB based on NICE criteria and multidisciplinary assessment
6.Written informed consent to participate.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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. ;<br> Secondary Objective: To determine whether the addition of liraglutide to the gastric band results in:<br> •Greater improvement in insulin resistance<br> •Greater rates of diabetes remission<br> •Greater weight loss<br> •Greater reduction in body fat<br> •Greater improvement in quality of life<br> •Greater improvement in markers of cardiovascular risk<br> •Greater increase in physical activity levels<br>