E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This trial will investigate the effects of the study treatment arms (gastric band + placebo; gastric band + liraglutide) on diabetes resolution in obese patients. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 |
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
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 (eGFR<60ML/MIN/1.73m2) and hepatic impairment, discontinue treatment if symptoms of acute pancreatitis (persistent, severe abdominal pain)). 7. Previous treatment with GLP-1 8. Purely diet controlled 9. Patients with HbA1C>11% 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 |
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E.5 End points |
E.5.1 | 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.
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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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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.8.3 |
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 | No |
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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The trial will end when the last participant has undergone the last visit. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |