E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether the addition of liraglutide to the gastric band results in improved glycaemic control |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |