Overview

This trial is active, not recruiting.

Condition diabetic nephropathy
Treatments current therapy, irbesartan, ramipril, hydrochlorothiazide, furosemide, amlodipine, atenolol, doxazosin, clonidine, insulin, simvastatin, fibrate, erythropoietin, aspirin
Phase phase 4
Sponsor Second University of Naples
Start date March 2003
End date July 2012
Trial size 850 participants
Trial identifier NCT00535925, 246813579

Summary

The NID-2 study, a multicentric study (21 centres enrolled), was planned in two phases:

Phase 1(observational study, completed at 2007): after the identification of a type-2 diabetic population with typical DN, to study of the rate of renal and cardiovascular events during a middle term follow-up.

Phase 2(interventional study, started at 2007): 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Control group patients will continue their usual therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist.
current therapy
the patients have to be treated according the standard good medical practice by any center
(Experimental)
An intensive multifactorial intervention 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).
irbesartan
Therapy for hypertension: - Step 1: irbesartan 300 mg/die and ramipril 10 mg/die
ramipril
Therapy for hypertension: - Step 1: irbesartan 300 mg/die and ramipril 10 mg/die
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)
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)
amlodipine
Therapy for hypertension - Step 3: amlodipine up to 10 mg/die
atenolol
Therapy for hypertension - Step 4: atenolol up to 100 mg/die
doxazosin
Therapy for hypertension - Step 5: doxazosin up to 4 mg/die
clonidine
Therapy for hypertension - Step 6: clonidine
insulin
Therapy for Hyperglycaemia (to achieve HbA1c <7): - insulin
simvastatin
Therapy for hypercholesterolemia: - for reducing LDL cholesterol < 100 mg/dl: simvastatin up to 80 mg/die
fibrate
Therapy for hypertriglyceridemia - for reducing triglycerides < 150 mg/dl and/or increasing HDL cholesterol > 40-50 mg/dl: a fibrate
erythropoietin
Treatment of anaemia: - erythropoietin
aspirin
Antiplatelet therapy (in all patients without contraindications): - aspirin up to 160 mg/die

Primary Outcomes

Measure
CV events (total CV mortality, non fatal IMA, non fatal stroke, TIA, major amputations, by-pass or PTCA)
time frame: 4 years

Secondary Outcomes

Measure
A) (In patients with microalbuminuria) • Progression to macroalbuminuria • Regression to normoalbuminuria B) (In patients with macroalbuminuria) • Doubling time of serum creatinine • Reduction of proteinuria to <0,5 g/die
time frame: 4 years

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

Inclusion Criteria: - type 2 diabetic patients - 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 outpatient clinic for at least 12 months Exclusion Criteria: - type 1 diabetic patients - <40 years old

Additional Information

Official title Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.
Principal investigator Ferdinando C Sasso, MD, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by Second University of Naples.