Phase 4
Completed N=395
Nephropathy In Type 2 Diabetes and Cardio-renal Events
Source: ClinicalTrials.gov NCT00535925 ↗Enrolled (actual)
395
Serious AEs
39.8%
Results posted
May 2020
Primary outcomePrimary: "Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)" — 146; 116 Participants — p=<0.05
◆ Published Evidence
Highly cited
132citations · ~26 / year
Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2 diabetic kidney disease.
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.
Linked Publications (3)
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Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2 diabetic kidney disease.
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The number of risk factors not at target is associated with cardiovascular risk in a type 2 diabetic population with albuminuria in primary cardiovascular prevention. Post-hoc analysis of the NID-2 trial.
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Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy. A multicenter prospective 8 years follow up study.
Outcome Measures
| Outcome | Result | p-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 | — |
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
Data sourced from ClinicalTrials.gov (NCT00535925) and the linked publication. 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. Informational only — not medical advice.