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Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Valsartan 160 mg + nateglinide 60 mg (Drug); Valsartan 160 mg + nateglinide placebo (Drug); Nateglinide 60 mg + valsartan placebo (Drug); Valsartan placebo + nateglinide placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are considered "borderline" based on blood tests. People in the study take none, one or both of the drugs and do not know which one(s) they are taking.

Clinical Details

Official title: A Multinational, Randomized, Double-blind, Placebo-controlled, Forced-titration, 2 x 2 Factorial Design Study of the Efficacy and Safety of Long-term Administration of Nateglinide and Valsartan in the Prevention of Diabetes and Cardiovascular Outcomes in Subjects With Impaired Glucose Tolerance (IGT)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome:

Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan

Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan

Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan

Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide

Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide

Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults

- Impaired glucose tolerance

- Age dependent risk factors

Exclusion Criteria:

- Frank diabetes

For detailed information, call contact person.

Locations and Contacts

Investigative Site, Argentina

Investigative Site, Australia

Investigative Sites, Austria

Investigative Site, Belgium

Investigative Site, Brazil

Investigative Site, Canada

Investigative Site, Chile

Investigative Site, China

Investigative Site, Colombia

Investigative Site, Czech Republic

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

Investigative Site, New Jersey, United States

Additional Information

Starting date: January 2002
Last updated: June 27, 2011

Page last updated: August 23, 2015

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