Nephropathy In Type 2 Diabetes and Cardio-renal Events - Full Text View

Sponsor:	Second University of Naples
Information provided by (Responsible Party):	Sasso Ferdinando Carlo, Second University of Naples
ClinicalTrials.gov Identifier:	NCT00535925

Purpose

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.

Condition	Intervention	Phase
Diabetic Nephropathy	Drug: current therapy Drug: irbesartan Drug: ramipril Drug: hydrochlorothiazide Drug: furosemide Drug: amlodipine Drug: atenolol Drug: doxazosin Drug: clonidine Drug: insulin Drug: simvastatin Drug: fibrate Drug: erythropoietin Drug: aspirin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Diabetic Kidney Problems High Blood Pressure

Drug Information available for: Acetylsalicylic acid Furosemide Hydrochlorothiazide Insulin Insulin beef Erythropoietin Atenolol Doxazosin Doxazosin mesylate Simvastatin Ramipril Amlodipine Amlodipine besylate Epoetin alfa Irbesartan Clofibric acid Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by Second University of Naples:

Primary Outcome Measures:

CV events (total CV mortality, non fatal IMA, non fatal stroke, TIA, major amputations, by-pass or PTCA) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment:	850
Study Start Date:	March 2003
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: current therapy the patients have to be treated according the standard good medical practice by any center
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).	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

Assigned Interventions

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.

Drug: current therapy

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

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).

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

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).

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535925

Locations

Italy
Department of Clinical and Experimental Medicine, Second University of Naples
Naples, Italy, I-80131

Sponsors and Collaborators

Second University of Naples

Investigators

Principal Investigator:	Ferdinando C Sasso, MD, PhD	Second University of Naples
Study Director:	Roberto Torella, Prof, MD	Second University of Naples
Study Chair:	Luca De Nicola, Prof, MD	Second University of Naples

More Information

Publications:

Sasso FC, De Nicola L, Carbonara O, Nasti R, Minutolo R, Salvatore T, Conte G, Torella R. Cardiovascular risk factors and disease management in type 2 diabetic patients with diabetic nephropathy. Diabetes Care. 2006 Mar;29(3):498-503.

Minutolo R, Sasso FC, Chiodini P, Cianciaruso B, Carbonara O, Zamboli P, Tirino G, Pota A, Torella R, Conte G, De Nicola L. Management of cardiovascular risk factors in advanced type 2 diabetic nephropathy: a comparative analysis in nephrology, diabetology and primary care settings. J Hypertens. 2006 Aug;24(8):1655-61.

Responsible Party:	Sasso Ferdinando Carlo, Assistant Professor, Second University of Naples
ClinicalTrials.gov Identifier:	NCT00535925 History of Changes
Other Study ID Numbers:	246813579
Study First Received:	September 24, 2007
Last Updated:	December 20, 2011
Health Authority:	Italy: Ethics Committee

Keywords provided by Second University of Naples:

type 2 diabetes
nephropathy
CV events

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Aspirin
Clonidine
Atenolol
Hydrochlorothiazide
Amlodipine
Ramipril

Doxazosin
Irbesartan
Simvastatin
Epoetin Alfa
Clofibric Acid
Furosemide
Insulin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012