NCT00535925

Nephropathy In Type 2 Diabetes and Cardio-renal Events

Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 850 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetic Nephropathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-10-01
• Primary completion: 2011-12-01
• Completion: 2019-05-01
• First posted: 2007-09-27
• Last updated: 2020-08-03
• Results posted: 2020-05-11

Locations

1 site across 1 country: Italy