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Preventing Microalbuminuria in Type 2 Diabetes (VARIETY)
This study is currently recruiting participants.
Verified by Mario Negri Institute for Pharmacological Research, July 2007
First Received: July 17, 2007   No Changes Posted
Sponsored by: Mario Negri Institute for Pharmacological Research
Information provided by: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT00503152
  Purpose

In people with type 2 diabetes, microalbuminuria is a strong, independent risk factor for diabetic nephropathy and cardiovascular morbidity and mortality. ACE inhibitor therapy decreased the risk of microalbuminuria in hypertensive subjects with type 2 diabetes and normoalbuminuria by about 40%. Available data suggest that angiotensin II receptor blockers (ARBs) might have a similar renoprotective effect and that this effect might be increased by combined ACE inhibitor therapy. The study will evaluate the effects, at similar blood pressure control (systolic/diastolic <130/80 mmHg), for a period of three years, of dual renin-angiotensin-system (RAS) blockade by benazepril and valsartan combination therapy as compared to single RAS blockade by benazepril or valsartan alone on microalbuminuria and cardiovascular events in high-risk patients with type 2 diabetes, creatinine <1.5 mg/dl, no evidence of microalbuminuria but at high risk of renal disease, with hypertesion and a urinary albumin excretion between 10 and 19 microgrammi/min. The relationship between albuminuria and cardiovascular outcomes will also be evaluated. The study is expected to show a more effective prevention of microalbuminuria and cardiovascular events with combined than with single drug ACE inhibitor or ARB therapy. As compared to ACE inhibitor, ARB therapy is expected to have a similar effect on microalbuminuria, but an inferior cardioprotective effect. Applied to clinical practice, the findings should help preventing renal and cardiovascular complications, and related treatment costs, of type 2 diabetes.


Condition Intervention Phase
Diabetes
Drug: Benazepril
Drug: Valsartan
Drug: Benazepril/Valsartan
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective, Randomized, Probe Trial to Evaluate Whether, at Comparable Blood Pressure Control, Combined Therapy With the ACEI Benazepril and the ARB Valsartan, Reduces the Incidence of Microalbuminuria More Effectively Than BEN or VAL Alone in Hypertensive Patients With Type 2 Diabetes and High-Normal Albuminuria

Resource links provided by NLM:


Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • Development of persistent microalbuminuria (i.e. urinary albumin excretion rate >20 µg/min in at least 2 of 3 consecutive overnight urine collections confirmed in two consecutive visits). Whenever a patient will be found to have 2 of 3 collections in the [ Time Frame: 2 times a year ]

Secondary Outcome Measures:
  • Regression to low-normal albuminuria (i.e. urinary albumin excretion rate <10 µg/min in at least 2 of 3 consecutive overnight urine collections confirmed in two consecutive visits); Albuminuria (considered as a continuous variable); Serum creatinine (v [ Time Frame: 2 times a year ]

Estimated Enrollment: 1233
Study Start Date: May 2007
Estimated Study Completion Date: December 2012
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females >40 years old;
  • High-risk subjects with type 2 diabetes (WHO criteria);
  • History of diabetes not exceeding 25 years;
  • High blood pressure (systolic and/or diastolic blood pressure >135/85 mmHg or concomitant treatment with blood pressure lowering medications);
  • Serum creatinine concentration <1.5 mg/dl;
  • Overnight urinary albumin excretion (in at least 2 of 3 consecutive overnight urine collections) >10 and <20 µg/min;
  • Legal capacity;
  • Written informed consent.

Exclusion Criteria:

  • Uncontrolled diabetes (glycated hemoglobin >11%);
  • Specific contraindications or history of hypersensitivity to the study drugs;
  • Serum potassium ≥ 5.5 mEq/L despite diuretic therapy, and optimized metabolic and acid/base control;
  • Bilateral renal artery stenosis;
  • Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer;
  • Drug or alcohol abuse;
  • Any chronic clinical conditions that may affect completion of the trial or confound data interpretation;
  • Pregnancy or lactating;
  • Women of childbearing potential without following a scientifically accepted form of contraception;
  • Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
  • Evidence of an uncooperative attitude;
  • Any evidence that patient will not be able to complete the trial follow-up.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503152

Contacts
Contact: piero ruggenenti, MD 0039 035 45351 ruggenenti@marionegri.it

Locations
Italy
Hospital "Azienda Ospedaliera Ospedali Riuniti di Bergamo" - Unit of Diabetology Recruiting
Bergamo, Italy
Contact: Roberto Trevisan, MD     0039 035 266968     rtrevisan@ospedaliriuniti. bergamo.it    
IRCCS San Raffaele - Unit of General Medicine Not yet recruiting
Milano, Italy
Contact: emanuele bosi, MD     0039 02 26431     bosi.emanuele@hsr.it    
Sub-Investigator: Gianpaolo Zerbini, MD            
Azienda USL 2 Not yet recruiting
Olbia, Italy
Contact: Giancarlo Tonolo, MD         giancarlo.tonolo@aslolbia.it    
Italy, Bergamo
Clinical Research Center for Rare Diseases "Aldo e Cele Daccò" Recruiting
Ranica, Bergamo, Italy
Contact: Varusca Brusegan, MD     0039 035 4535321     brusegan@marionegri.it    
Hospital "Azienda Ospedaliera di Treviglio-Caravaggio"Unit of Diabetology and Metabolic Diseases Recruiting
Treviglio, Bergamo, Italy
Contact: antonio bossi, MD     0039 0363 4241     antoniobossi@ospedale.treviglio.bg.it    
Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" Unit of Diabetology and Metabolic Diseases Not yet recruiting
Romano di Lombardia, Bergamo, Italy
Contact: Antonio Bossi, MD     0039 0363 4241     antonio_bossi@ospedale.treviglio.bg.it    
Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" - Diabetologic Ambulatory of Ponte San Pietro Not yet recruiting
Ponte San Pietro, Bergamo, Italy
Contact: Antonio Belviso, MD     0039 035 603449     belvisoa@tiscali.it    
Italy, Foggia
Hospital "Casa Sollievo della Sofferenza" - Division of Endocrinology Not yet recruiting
San Giovanni Rotondo, Foggia, Italy
Contact: vincenzo trischitta, MD         vincenzo.trischitta@uniroma1.it    
Sub-Investigator: Salvatore De Cosmo, MD            
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
Study Director: Piero Ruggenenti, MD Mario Negri Institute for Pharmacological Research
  More Information

No publications provided

Study ID Numbers: VARIETY
Study First Received: July 17, 2007
Last Updated: July 17, 2007
ClinicalTrials.gov Identifier: NCT00503152     History of Changes
Health Authority: Italy: Ministry of Health

Study placed in the following topic categories:
Albuminuria
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Protease Inhibitors
Diabetes Mellitus, Type 2
Benazepril
Angiotensin-Converting Enzyme Inhibitors
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Valsartan

Additional relevant MeSH terms:
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses
Diabetes Mellitus, Type 2
Benazepril
Angiotensin-Converting Enzyme Inhibitors
Glucose Metabolism Disorders
Valsartan

ClinicalTrials.gov processed this record on September 11, 2009