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Phase 4 N=395 Randomized Prevention

Nephropathy In Type 2 Diabetes and Cardio-renal Events

Diabetic Nephropathy

Bottom Line

View on ClinicalTrials.gov: NCT00535925 ↗
Enrolled (actual)
395
Serious AEs
39.8%
Results posted
May 2020
Primary outcome: Primary: "Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)" — 146; 116 Participants — p=<0.05

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
SoC 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 (Drug)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
University of Campania Luigi Vanvitelli
Primary completion
Dec 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
"Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)"		 146; 116 <0.05 sig
SECONDARY
"Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase"		 150; 191 —

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00535925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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