Type 2 diabetes, diabetic kidney disease MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861 MedDRA version: 21.1 Level: LLT Classification code 10045250 Term: Type II diabetes mellitus with renal manifestations System Organ Class: 100000004857
Conditions
Interventions
Trade Name: Ezetimibe "Sandoz"
Pharmaceutical Form: Capsule
INN or Proposed INN: EZETIMIBE
CAS Number: 163222-33-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1
Sponsors
Steno Diabetes Center Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Please refer to E.3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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. ;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) ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Denmark
Contacts
Public ContactComplication Research
Steno Diabetes Center Copenhagen
Outcome results
None listed