E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
obese type 2 diabetic hemodialysis patients |
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E.1.1.1 | Medical condition in easily understood language |
obese type 2 diabetic hemodialysis patients |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
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 |
Assess weight loss in obese diabetic patients on hemodialysis after 6 months of treatment with liraglutide in order to facilitate access to renal transplants for patients who have been rejected for being overweight |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives correspond to: - establish the number and percentage of patients whose CIT transplant for obesity will be lifted after 6 months of treatment - study the tolerance of liraglutide in type 2 diabetic patients on hemodialysis - assess the impact of liraglutide on the treatment already in place to regulate blood sugar - evaluate the modifications of the glycemic balance under liraglutide between M0 and M6 - assess the percentage of hypoglycaemia during the day using the free freestyle pro sensors - evaluate the modifications of the dry mass and the fatty mass between M0 and M6 - evaluate the therapeutic monitoring of patients before and after the dialysis session |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patient aged ≥ 18 and <70 - Patient on hemodialysis for more than 6 months - Type 2 diabetic patient - Patient with a BMI> 30 kg / m2 with a Temporary Contraindication for kidney transplant for renal transplant due to overweight by his graft center - Patient affiliated to a health insurance plan - French speaking patient - Patient having given free, informed and written consent |
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E.4 | Principal exclusion criteria |
- Patient with a Temporary Contraindication for kidney transplant for a cause other than overweight - Patient with personal or family history of thyroid medullary cancer - Patient with a history of acute or chronic pancreatitis - Patient who has already had hypersensitivity to liraglutide (or to any other component of the product) - Patient who has already had a severe digestive intolerance to taking GLP-1 receptor agonists (such as exenatide or lixisenatide) - Patient already included in an interventional risk research protocol (RIPH1) - Pregnant or lactating woman - Patient under guardianship or curatorship - Patient deprived of liberty |
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E.5 End points |
E.5.1 | Primary end point(s) |
weight loss (in kg) after 6 months of treatment with liraglutide. |
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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) |
The criteria for secondary judgments correspond to: - the number and percentage of patients whose BMI is <30 kg / m2 after treatment and for whom the transplant weight contraindication is removed - the number and percentage of serious and non-serious adverse events in patients with type 2 diabetes on hemodialysis - the decrease in the number / dose of anti-diabetic drugs or the daily insulin dose - comparison of the average variations of glycated hemoglobin (HbA1c) between M0 and M6 - the frequency of hypoglycaemia during the day in all patients via free freestyle pro sensors - comparison of variations in the percentage of dry mass and fat mass between M0 and M6 - the concentration of liraglutide before and after the dialysis session |
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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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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 | 4 |
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 end of the trial corresponds to the last visit of the last subject. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |