Clinical trial NCT00535925
Conditions: Diabetic Nephropathy
Keywords: type 2 diabetes nephropathy cardiovascular (CV) events
Sponsor: University of Campania Luigi Vanvitelli
Start date: 2005-10-01; Completion date: 2019-05-01
Enrollment: 850 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
The same patients that completed the first phase of the NID-2 study (observation) were enrolled for the phase 2 of the study (intervention).

Arms: arm 1: Control group patients will continue their SoC therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist. arm 2: An intensive multifactorial intervention according Scientific Guidelines is performed to achieve the goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia.

In particular, new antihypertensive drugs will be added one by one until the achievement of blood pressure target (\<130/80 mmHg).
Interventions: intervention 1: SoC therapy intervention 2: irbesartan intervention 3: ramipril intervention 4: hydrochlorothiazide intervention 5: furosemide intervention 6: amlodipine intervention 7: atenolol intervention 8: doxazosin intervention 9: clonidine intervention 10: insulin intervention 11: simvastatin intervention 12: fibrate intervention 13: erythropoietin intervention 14: aspirin
Intervention descriptions: intervention 1: the patients have to be treated according the standard good medical practice by any center intervention 2: Therapy for hypertension:

\- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die intervention 3: Therapy for hypertension:

\- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die intervention 4: 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) intervention 5: 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) intervention 6: Therapy for hypertension

\- Step 3: amlodipine up to 10 mg/die intervention 7: Therapy for hypertension

\- Step 4: atenolol up to 100 mg/die intervention 8: Therapy for hypertension

\- Step 5: doxazosin up to 4 mg/die intervention 9: Therapy for hypertension

\- Step 6: clonidine intervention 10: Therapy for Hyperglycaemia (to achieve HbA1c \<7):

\- insulin intervention 11: Therapy for hypercholesterolemia:

\- for reducing LDL cholesterol \< 100 mg/dl: simvastatin up to 80 mg/die intervention 12: Therapy for hypertriglyceridemia

\- for reducing triglycerides \< 150 mg/dl and/or increasing HDL cholesterol \> 40-50 mg/dl: a fibrate intervention 13: Treatment of anaemia:

\- erythropoietin intervention 14: Antiplatelet therapy (in all patients without contraindications):

\- aspirin up to 160 mg/die

Protocol documents: