E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes, diabetic kidney disease |
Type 2 diabetes, diabetisk nyresygdom |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes, diabetic kidney disease |
Type 2 diabetes, diabetisk nyresygdom |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045250 |
E.1.2 | Term | Type II diabetes mellitus with renal manifestations |
E.1.2 | System Organ Class | 100000004857 |
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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 assess by intervention trial whether ezetimibe reduces albuminuria and kidney parenchymal triglyceride fraction in individuals with type 2 diabetes and non-severe diabetic kidney disease.
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E.2.2 | Secondary objectives of the trial |
To compare cross-sectionally the fractions of kidney lipid between controls, individuals with type 2 diabetes and no diabetic kidney disease and individuals with type 2 diabetes and non-severe diabetic kidney disease. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Main eligibility criteria for control group (cross-sectional study alone): • No diabetes mellitus • No kidney disease or urinary albumin creatinine ratio ≥ 30mg/g • No contraindication to examination by magnetic resonance Main eligibility criteria for control group (cross-sectional study alone): • Age 40-80 years • No diabetes mellitus • No kidney disease or urinary albumin creatinine ratio ≥ 30mg/g • No contraindication to examination by magnetic resonance Main eligibility criteria for group of individuals with type 2 diabetes and no diabetic kidney disease (cross-sectional study alone): • Age 40-80 years • Type 2 diabetes • No kidney disease or urinary albumin creatinine ratio ≥ 30mg/g • No contraindication to examination by magnetic resonance Main eligibility criteria for group of individuals with type 2 diabetes and non-severe diabetic kidney disease (intervention trial): • Age 40-80 years • Type 2 diabetes • Estimated glomerular filtration rate ≥30ml/min/1,73m2 • Urinary albumin creatinine ratio ≥ 30mg/g • No contraindication to examination by magnetic resonance
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint in intervention trial: • Urinary albumin creatinine ratio
Primary endpoint in cross-sectional part of study: • Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
For intervention trial: At baseline (randomization visit) and at end of treatment of 16 weeks
For cross-sectional part of study: At baseline |
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E.5.2 | Secondary end point(s) |
Secondary endpoints in intervention trial: • Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy) • MR estimate (by Dixon’s method) of kidney parenchymal fat fraction
Secondary endpoints in cross-sectional part of study • MR estimate (by Dixon’s method) of kidney parenchymal fat fraction
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For intervention trial: At baseline (randomization visit) and at end of treatment of 16 weeks
For cross-sectional part of study: At baseline |
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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 | No |
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
| 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 | 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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Last visit of 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 | |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |