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DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-008-02
1. ORGANIZATION / APPLICANTE INSTITUTION
Name of Organization / Institution: NOVARTIS BIOSCIENCES PERÚ S.A.   Type of Organization / Institution : Empresa / Compañia 
Legal Domicile : Jr. Juan de Arona 151, Oficinas 601-602 
District: San Isidro  Province: San Isidro 
Departament: LIMA 
Single Taxpayer No : 20100129028 
Telephone: 2006400   Fax: 2006400 
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROL, WITH FORCED TITRATION, FACTORIAL DESIGN OF 2 X 2, TO EVALUATE THE EFFICACY AND SAFETY OF THE LONG-TERM ADMINISTRATION OF NATEGLINIDA AND VALSARTAN IN THE PREVENTION OF DIABETES AND DISORDERS CARDIOVASCULARS IN SUBJECTS WITH GLUCOSE DEFICIENT TOLERANCE (IGT).


Public Title
MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROL, WITH FORCED TITRATION, FACTORIAL DESIGN OF 2 X 2, TO EVALUATE THE EFFICACY AND SAFETY OF THE LONG-TERM ADMINISTRATION OF NATEGLINIDA AND VALSARTAN IN THE PREVENTION OF DIABETES AND DISORDERS CARDIOVASCULARS IN SUBJECTS WITH GLUCOSE DEFICIENT TOLERANCE (IGT).


Clinical Trial Registration Date Most recent Clinical Trial Update
11/01/2002  
Principal Sponsor :
1.- NOVARTIS BIOSCIENSES PERU S.A.  
Secondary Sponsor :
 
Funding Source
Executing Company / Institution / Other
- NOVARTIS BIOSCIENCES PERÚ S.A. Authorized with   Nº 011-2002(DGSP) Date 11/01/2002
Responsabilities
 
  Others
 
  Inform to the OGITT of the NIH when the first subject is enrolled in Peru, and the end date of enrollment in the country.
 
  Submit progress reports to the National Health Institute during the execution of the Clinical Trial.
 
  Submit to the OGITT of the NIH the final reports as well as the results, conclusions, and publication of the clinical trial
 
  Notify to the OGITT of the NIH the adverse events and deviations as established in the Clinical Trials Regulation.
 
  Inform and describe the reasons for a suspension and cancellation of the clinical trial.
 
  Provide the facilities for the inspection of the execution of the clinical trial by the staff of the General Office of Research and Technology Transfer (OGITT) of the National Institute of Health.
Study clinical phase: III  Protocol Code CDJN608B2302 
Secondary ID(s) :  
WHO UTN: NA
CLINICALTRIALS.GOV: NCT00097786
EUDRACT N°:NA
Study Design
Multicenter, randomized, double-blind, placebo-controlled, forced titration, 2x2 factorial design trial to evaluate the effect of nateglinide and valsartan on the prevention of diabetes and cardiovascular events in subjects with impaired glucose tolerance 
Insurance policy due date   Assignation method Randomized 
Non randomized 
Type of blinding Assignation
Simple  Double  Triple 
Open
Single arm        Parallel
Crossed                 Factorial
Others:
Purpose
• To evaluate the effect of long-term administration of nateglinide and valrate on the progression to diabetes in subjects with impaired glucose tolerance (IGT) with increased risk of a cardiovascular event. • To assess the effect of long-term administration of nateglinide and valrate on cardiovascular morbidity and mortality, defined as a composite endpoint (CV endpoint) of cardiovascular death, non-fatal myocardial infarction, nonfatal stroke, procedure of revascularization, and hospitalization for congestive heart failure or unstable angina. Data on the components of this composite endpoint will be collected for the entire duration of this trial. • To assess the effect of long-term administration of nateglinide and valrate on cardiovascular morbidity and mortality, defined as a composite endpoint (CV endpoint) of cardiovascular death, non-fatal myocardial infarction, nonfatal stroke, and hospitalization for congestive heart failure. Data on the components of this composite endpoint will be collected for the entire duration of this trial. 
Research Product Information
Name of the product Generic Name Type of product ATC
- DJN608
Intervention(s) description:
Group name Type of group N° of participants Intervention(s) description
Nateglinide Experimental
Control
2288   Eligible subjects will enter a period of treatment-free admission of up to 4 weeks. In randomization (Visit 2), subjects will be assigned to nateglinide 30 mg before meals for two weeks, then go to level 2 (nateglinide 60 mg).
valsartan Experimental
Control
2288   Eligible patients will enter a period of treatment-free admission of up to 4 weeks. In the randomization (Visit 2), subjects will be assigned to valsartan 80 mg before meals for two weeks, then go to level 2 (valsartan 160 mg).
Nateglinide + valsartan Experimental
Control
2288   Eligible patients will enter a period of treatment-free admission of up to 4 weeks. In the randomization (Visit 2), subjects will be assigned to nateglinide 30 mg + valsartan 80 mg before meals for two weeks, then go to level 2 (nateglinide 60 mg + valsartan 160 mg).
Inclusion Criteria
• Written informed consent to participate in the study • Men and women. Women must be surgically sterile or postmenopausal. • Age 50 years or older • 2 hr post-challenge glucose (after 75 g OGT) & 140 mg / dL (7.8 mmol / L) but less than 200 mg / dL (11.1 mmol / L) in Visit 1  
Exclusion Criteria
• Inability to provide written informed consent • Evidence of liver disease defined as SGOT or SGPT> 2 times the upper limit of normal in Visit 1 • Renal insufficiency with serum creatinine> 2.5 mg / dL (221 umol / L) in the Visit 1 • Clinically significant laboratory abnormalities that may interfere with the evaluation of the safety and / or efficacy of the study drug. • Patients who require replacement thyroid hormone who have been in their current medication dosage at least 3 months before the month. • History of malignancy, including leukemia or lymphoma (but not basal cell skin cancer) within the last 5 years • Patients with an ACE inhibitor for hypertension who are unable or unwilling to discontinue the medication under the supervision of their physician at least 4 weeks before the selection and during the full course of double-blind treatment. 
Worldwide enrolment start date  
Enrolment start date in Peru (Initial)   Enrolment start date in Peru  
Peru enrolment status Without starting enrollment
Enrollment stopped
  In enrollment
  Enrollment closed 
Clinical Trial Total Duration 84  months Medical Speciality ENDOCRINOLOGY 
Studied Condition (CIE-10 code) -E149 Unspecified diabetes mellitus, without complications  
Number of subjects to be included in all the countries 9306 
Number of subjects to be included in Peru (initial) Number of subjects to be included in Peru (posterior)
87 87
Countries where the enrolment is conducted :
- Chad - Malasya - Pakistan
- Singapore - Taiwan - Turkey
- Germany - Belgium - Denmark
- Slovakia - Spain - Finland
- France - Greece - Netherlands
- Hungary - Italy - Norway
- Poland - United Kindgdom - Russian Federation
- Sweden - Switzerland - Australia
- Czech Republic - South Africa - Argentina
- Brazil - Canada - Chile
- Colombia - Cape Verde - Ecuador
- Mexico - Peru - Uruguay
- United States
Number of participants per gender (Initial) Female: 0 
Male : 0 
Number of participants per gender (Posterior) Female: 0 
Male : 0
Range of age of subjects to be included : NA
Subjects' treatment time 69  month(s) Subjects' follow up time 84  month(s)
Primary Outcome  
Name of the outcome Metric or method of measurement Time point for the outcome
Effect of nateglinide and valsartan on cardiovascular morbidity and mortality, defined as a set of cardiovascular death, myocardial infarction, cerebrovascular accident (stroke), and hospitalization for congestive heart failure. FPG> 126 mg / dL (7 mmol / L) or later glucose (2 hours) to the Carbohydrate overload (HG) test> 200 mg / dL (11.1 mmol / L) during the test, a Repeat the TTOG within 4 weeks. The FPG confirmation date> 126 m¿ / dL (7mmol / L) or later glucose (2 hours) at challenge> 200 mg / dL (11.1 mmol / L) during the TTOG repeat is the primary objective in the central phase (time to progression to diabetes). 2 weeks 
Secondary Outcome
Name of the outcome Metric or method of measurement Time point for the outcome
The core phases and extension of the study is the time until the appearance of the first event of cardiovascular morbidity / mortality Time until the appearance of the first cardiovascular morbidity / mortality event (including cardiovascular death, non-fatal myocardial infarction, non-fatal heart attack, revascularization procedure, hospitalization due to congestive heart failure, hospitalization due to unstable angina). 2 weeks 
3. RESEARCH SITE, PRINCIPAL INVESTIGATOR, ETHICS COMMITTEE
Research site where the clinical trial will be conducted Principal Investigator Institutional Research Ethics Committee (CIEI) that approved the trial for the site Observations
Research Institution RCI Research site Full name RCEI Ethics Committe Name Status Approval date End approval date Term Telephone number Email addrees
ADMINISTRADORA CLÍNICA RICARDO PALMA S.A. RCI 759 Centro de Investigación Ricardo Palma
JOSÉ MANUEL AMERICO DRAGO SILVA

RCEI-14 UNIVERSIDAD PERUANA CAYETANO HEREDIA - COMITÉ INSTITUCIONAL DE ÉTICA EN INVESTIGACIÓN - CIEI DE LA UNIVERSIDAD PERUANA CAYETANO HEREDIA - UPCHApproved 27/12/2001 127126450 hguerra@upch.edu.pe  
Co-Investigator
 
HOSPITAL NACIONAL ALBERTO SABOGAL SOLOGUREN DE LA RED ASISTENCIAL SABOGAL RCI 78 Unidad de Investigación, Hospital Nacional IV Alberto Sabogal Sologuren, Essalud, Red Asistencial Sabogal
ALDO EDWIN RODRIGUEZ ESCUDERO

RCEI-14 UNIVERSIDAD PERUANA CAYETANO HEREDIA - COMITÉ INSTITUCIONAL DE ÉTICA EN INVESTIGACIÓN - CIEI DE LA UNIVERSIDAD PERUANA CAYETANO HEREDIA - UPCHApproved 25/09/2007 02/10/2008137126450 hguerra@upch.edu.pe  
Co-Investigator
 
COMPLETION DATE:
4. IPD SHARING STATEMENT
Is there a plan for sharing of deidentified individual clinical trial participant-level data (IPD) to other researchers (including data dictionaries)?
Yes   No Non decided
In case the answer is affirmative, describe the Plan.
 
Additional information that will be shared. Study protocol
Statistical Analysis Plan
Informed Consent Form
Clinical Study report
Others: ________________
Describe briefly when this information will be available and how it can be obtained
 
URL
5. CLINICAL TRIAL CONTACT PERSONS INFORMATION
Full Name E-mail Telephone Type of queries to be resolved
Information to general public Administrative Consultations Scientific Consultations
 
AUTHORIZATION STATUS
AUTHORIZED    FINISHED
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  Nº 011-2002(DGSP) AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 11/01/2002  (Validity date from:11/01/2002)
SUMMARY EVALUATION REPORT
APPROVED PROCEDURES
TYPE OF PROCEDURE TYPE AND NUMBER OF RESOLUTION / OFFICIAL LETTER DATE OF RESOLUTION / OFFICIAL LETTER VALIDITY DATE ANNULATION
FROM

TO

 

Clinical Trial Progress Report
 
04/04/2003

Clinical Trial Progress Report
 
26/06/2003

Clinical Trial Authorization Renewal
 RJ-359-2003-J-OPD/INS
03/07/2003
03/07/2003
03/07/2004

Clinical Trial Progress Report
 
02/12/2003

Clinical Trial Progress Report
 
02/12/2003

Clinical Trial Progress Report
 
20/05/2004

Clinical Trial Authorization Renewal
 647-2004 (INS)
07/09/2004
07/09/2004
07/09/2005

Clinical Trial Authorization Renewal
 RJ-647-2004-J-OPD/INS
07/09/2004
07/09/2004
07/09/2005

Clinical Trial Authorization Renewal
 RJ 647-2004-J-OPD/INS
07/09/2004
07/09/2004
07/09/2005

Clinical Trial Progress Report
 
20/09/2004

Clinical Trial Progress Report
 
21/01/2005

Clinical Trial Progress Report
 
21/03/2005

Clinical Trial Progress Report
 
13/06/2005

Clinical Trial Authorization Renewal
 RJ- 523-2005-J-OPD/INS
20/09/2005
20/09/2006
20/09/2007

Clinical Trial Progress Report
 
27/10/2005

Clinical Trial Progress Report
 
03/11/2005

Clinical Trial Progress Report
 
07/06/2006

Clinical Trial Authorization Renewal
 RJ-567-2006-J-OPD/INS
20/09/2006
20/09/2006
20/09/2007

Clinical Trial Authorization Renewal
R.D. Nº 457-2007-DG-OGITT-OPD/INS
27/09/2007
20/09/2007
20/09/2008

Clinical Trial Progress Report
 Exp. Nº 00036936-07
29/11/2007

Clinical Trial Progress Report
 Informe de Avance
02/06/2008

Extension / Modification of Supply List
R.D. Nº 394-2008-DG-OGITT-OPE/INS
02/07/2008

Clinical Trial Authorization Renewal
R.D. N° 561-2008-DG-OGITT-OPE/INS
19/09/2008
20/09/2008
20/09/2009

Clinical Trial Amendment Report
 1468-2008-DG-OGITT-OPE/INS
05/11/2008
05/11/2008

Clinical Trial Progress Report
 
18/11/2008

Clinical Trial Progress Report
 
20/07/2009

Clinical Trial Term Extension
R.D. N° 1005-2009-DG-OGITT-OPE/INS
30/10/2009
20/09/2009
20/09/2010

Clinical Trial Progress Report
 
13/01/2010

Research Center Final Report
 
13/01/2010

Clinical Trial National Final Report
 Informe Final Nacional
04/02/2010

Clinical Trial International Final Report
 
23/12/2015 03:44:11 p.m.