| Trial ID: | L3209 |
| Source ID: | NCT00097786
|
| Associated Drug: |
Valsartan 160 Mg + Nateglinide 60 Mg
|
| Title: |
Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications
|
| Acronym: |
Navigator
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00097786/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Valsartan 160 mg + nateglinide 60 mg|DRUG: Valsartan 160 mg + nateglinide placebo|DRUG: Nateglinide 60 mg + valsartan placebo|DRUG: Valsartan placebo + nateglinide placebo
|
| Outcome Measures: |
Primary: Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan, Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee., Mean patient duration of 4.2 years|Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan, The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina., Mean patient duration of 5.6 years|Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan, The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure., Mean patient duration of 5.8 years|Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide, Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee., Mean patient duration of 4.2 years|Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide, The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina., Mean patient duration of 5.6 years|Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide, The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure., Mean patient duration of 5.8 years |
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
9306
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2002-01
|
| Completion Date: |
2009-10
|
| Results First Posted: |
2011-05-24
|
| Last Update Posted: |
2023-11-08
|
| Locations: |
Multiple Locations, New Jersey, United States|Investigative Site, Argentina|Investigative Site, Australia|Multiple Locations, Austria|Investigative Site, Belgium|Investigative Site, Brazil|Investigative Site, Canada|Investigative Site, Chile|Investigative Site, China|Investigative Site, Colombia|Investigative Site, Czechia|Investigative Site, Denmark|Investigative Site, Ecuador|Investigative Site, Finland|Investigative Site, France|Investigative Site, Germany|Investigative Site, Greece|Investigative Site, Guatemala|Investigative Site, Hong Kong|Investigative Site, Hungary|Investigative Site, Italy|Investigative Site, Malaysia|Investigative Site, Mexico|Investigative Site, Netherlands|Investigative Site, Norway|Investigative Site, Peru|Investigative Site, Poland|Investigative Site, Russian Federation|Investigative Site, Singapore|Investigative Site, Slovakia|Investigative Site, South Africa|Investigative Site, Spain|Investigative Site, Sweden|Investigative Site, Switzerland|Investigative Site, Taiwan|Investigative Site, Turkey|Investigative Site, United Kingdom|Investigative Site, Uruguay
|
| URL: |
https://clinicaltrials.gov/show/NCT00097786
|
