At a glance
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Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.
In Brief
A Phase 4 clinical trial evaluating SoC therapy, irbesartan, and 12 other interventions for Diabetic Nephropathy. Completed, enrolled 850 participants across 1 site.
Detailed Summary
The NID-2 study, a multicentric study (21 centres enrolled), was planned in two phases: Phase 1(observational study, completed in September 2005): after the identification of a type-2 diabetic population with typical Diabetic Nephropathy (DN), to study of the rate of renal and cardiovascular events during a middle term follow-up. Phase 2(interventional study, started in October 2005): after randomization in two groups, a group (intervention group) is treated with an intensive multifactorial intervention whose aim is to reduce morbidity and mortality due to diabetic complications. The other group (control group) continues the conventional therapy . To avoid bias in the treatment in each center, the randomization was performed for centre.
Study Details
Timeline
Interventions
the patients have to be treated according the standard good medical practice by any center
Therapy for hypertension: \- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die
Therapy for hypertension: \- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die
Therapy for hypertension \- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine \<2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)
Therapy for hypertension \- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine \<2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)
Therapy for hypertension \- Step 3: amlodipine up to 10 mg/die
Therapy for hypertension \- Step 4: atenolol up to 100 mg/die
Therapy for hypertension \- Step 5: doxazosin up to 4 mg/die
Therapy for hypertension \- Step 6: clonidine
Therapy for Hyperglycaemia (to achieve HbA1c \<7): \- insulin
Therapy for hypercholesterolemia: \- for reducing LDL cholesterol \< 100 mg/dl: simvastatin up to 80 mg/die
Therapy for hypertriglyceridemia \- for reducing triglycerides \< 150 mg/dl and/or increasing HDL cholesterol \> 40-50 mg/dl: a fibrate
Treatment of anaemia: \- erythropoietin
Antiplatelet therapy (in all patients without contraindications): \- aspirin up to 160 mg/die