Nephropathy In Type 2 Diabetes and Cardio-renal Events

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.

Conditions

• Diabetic Nephropathy

Interventions

DRUG

SoC therapy

the patients have to be treated according the standard good medical practice by any center

DRUG

irbesartan

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

DRUG

ramipril

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

DRUG

hydrochlorothiazide

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)

DRUG

furosemide

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)

DRUG

amlodipine

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

DRUG

atenolol

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

DRUG

doxazosin

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

DRUG

clonidine

Therapy for hypertension \- Step 6: clonidine

DRUG

insulin

Therapy for Hyperglycaemia (to achieve HbA1c \<7): \- insulin

DRUG

simvastatin

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

DRUG

fibrate

Therapy for hypertriglyceridemia \- for reducing triglycerides \< 150 mg/dl and/or increasing HDL cholesterol \> 40-50 mg/dl: a fibrate

DRUG

erythropoietin

Treatment of anaemia: \- erythropoietin

DRUG

aspirin

Antiplatelet therapy (in all patients without contraindications): \- aspirin up to 160 mg/die

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli

  lead OTHER

Principal Investigators

• Ferdinando C Sasso, MD, PhD · Università della Campania "Luigi Vanvitelli", Naples, Italy

• Roberto Minutolo, MD, MD · Università della Campania "Luigi Vanvitelli", Naples, Italy

• Luca De Nicola, MD, MD · Università della Campania "Luigi Vanvitelli", Naples, Italy

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-10-31

Primary Completion

2011-12-31

Completion

2019-05-31

Countries

• Italy

Study Locations