Nephropathy In Type 2 Diabetes and Cardio-renal Events

Diabetic Nephropathy Clinical Trial

— NID-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535925
• Other study ID #: 246813579
• Status: Completed
• Phase: Phase 4
• Start date: October 2005
• Est. completion date: May 2019

Study information

• Verified date: July 2020
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: May 2019
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• type 2 diabetic patients

• albumin extraction rate (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 outpatients clinic for at least 12 months

Exclusion Criteria:

• type 1 diabetic patients

• <40 years old

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• SoC therapy
the patients have to be treated according the standard good medical practice by any center
• 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

Locations

Country	Name	City	State
Italy	Department of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)"	number of MACEs in the two groups are reported. In addition, The primary endpoint was analyzed with event curves for the time-to-first event based on Kaplan-Meier analysis. Cox regression model was used to calculate hazard ratio (HR) and 95% Confidence Interval (CI). Due to the cluster randomized study design, a Cox shared-frailty model was fitted. multivariable model was adjusted for selected potential confounders: age, sex, systolic blood pressure (SBP), hemoglobin, estimated glomerular filtration rate (eGFR), albuminuria, HbA1c, total cholesterol and triglycerides (log-scaled) to reduce risk of bias.	4 years (in the case the number of events needed by sample size is not reached at the expected 4-year time frame, primary end point will be assessed after the follow-up phase)
Secondary	"Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase"	Achievement of targets at end of intervention was performed applying generalized estimating equation (GEE) models, further adjusting for baseline values as covariate.	13 years