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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Second University of Naples.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Sasso Ferdinando Carlo, Second University of Naples
ClinicalTrials.gov Identifier:
NCT00535925
First received: September 24, 2007
Last updated: December 20, 2011
Last verified: December 2011
  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 4

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:


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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 20, 2014