Nephropathy In Type 2 Diabetes and Cardio-renal Events (NID-2)

University of Campania "Luigi Vanvitelli"

Status and phase: Completed; Phase 4

Conditions: Diabetic Nephropathy

Treatments: Drug: hydrochlorothiazide; Drug: irbesartan; Drug: aspirin; Drug: SoC therapy; Drug: clonidine; Drug: simvastatin; Drug: ramipril; Drug: atenolol; Drug: fibrate; Drug: erythropoietin; Drug: amlodipine; Drug: doxazosin; Drug: furosemide; Drug: insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT00535925

246813579

Details and patient eligibility

About

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.

Full 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).

Enrollment: 850 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetic patients
• albumin extraction rate (AER= >30 mg/die (micro- or macro-albuminuric ranges) in at least two determinations in the last six months
• diabetic retinopathy
• patients followed in the outpatients clinic for at least 12 months

Exclusion criteria

• type 1 diabetic patients
• <40 years old

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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850 participants in 2 patient groups

Standard of Care (SoC) therapy

Active Comparator group

Description:

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.

Treatment:

Drug: SoC therapy

Multifactorial Intensified therapy

Experimental group

Description:

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).

Treatment:

Drug: clonidine

Drug: simvastatin

Drug: irbesartan

Drug: hydrochlorothiazide

Drug: atenolol

Drug: aspirin

Drug: amlodipine

Drug: doxazosin

Drug: ramipril

Drug: furosemide

Drug: fibrate

Drug: insulin

Drug: erythropoietin