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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Will liraglutide improve diabetes in patients who have not responded as well to surgery for obesity and diabetes? |
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E.2.2 | Secondary objectives of the trial |
We also want to find out whether giving patient who do not do well after surgery a daily injection of GLP-1 may also affect their: • body weight • systolic and diastolic blood pressure • total number of medications • insulin dose for those patients taking insulin as treatment for T2DM. • obesity-related comorbidities staging score • quality of life • total caloric intake and macronutrient composition • behavioural traits, ad libitum total food intake, sweet taste detection threshold, consummatory taste reward ratings, and wanting and liking for food pictures • number of hypoglycaemic episodes • adverse events
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female • Aged between 18-70 years • ≥12 months after gastric bypass or sleeve gastrectomy bariatric surgery • Diagnosed with Type 2 diabetes mellitus according to WHO 2006 and 2011 criteria • HbA1c >6.5% (>48 mmol/mol) on screening • On Metformin ± long acting insulin • Able to give informed consent |
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E.4 | Principal exclusion criteria |
• Diagnosed with Type 1 diabetes mellitus • Anatomical or endocrinological pathology causing poor weight loss or weight regain • Screening calcitonin of 50 ng/L or above • Family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma • Personal history of non-familial medullary thyroid carcinoma • History of acute or chronic pancreatitis • Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above) • Estimated glomerular filtration rate (eGFR) <30 ml/min • 1.73 m2). • Current pregnancy. • Inability to maintain adequate contraception. |
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E.5 End points |
E.5.1 | Primary end point(s) |
HbA1C reduction from baseline |
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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) |
change from baseline in: • body weight • systolic and diastolic blood pressure • total number of medications • insulin dose for those patients taking insulin as treatment for T2DM. • obesity-related comorbidities staging score • quality of life • total caloric intake and macronutrient composition • behavioural traits, ad libitum total food intake, sweet taste detection threshold, consummatory taste reward ratings, and wanting and liking for food pictures • number of hypoglycaemic episodes • adverse events
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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) | 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 | No |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
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 |