Official Title: “Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-Renal Events.”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Intervention(s) in this Clinical Trial

• Drug: current therapy
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 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.
• Experimental: 2
  • 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).

Primary Measures

• CV events (total CV mortality, non fatal IMA, non fatal stroke, TIA, major amputations, by-pass or PTCA)

Secondary Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Second University of Naples

Overall Clinical Trial Officials and Contacts

Ferdinando C Sasso, MD, PhD Principal Investigator Second University of Naples  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00535925

Study ID Number: 246813579

ClinicalTrials.gov Identifier: NCT00535925

Health Authority: Italy: Ethics Committee