CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9,306 enrolled
Drug / intervention
Valsartan 160 mg + nateglinide 60 mg +3 moredrug
Likely dose
Nateglinide 60 mg + Valsartan 160 mg (2x2 factorial design with placebo comparators)AI-extracted
Key inclusion· 3
  • ✓Adults
  • ✓Impaired glucose tolerance
  • ✓Age-dependent risk factors
Key exclusion· 1
  • ✕Established diabetes mellitus

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00097786
NCT00097786Phase 3Completed
CompareCT.gov

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)

Novartis Pharmaceuticals·interventional·Posted Dec 1, 2004·Updated Nov 8, 2023

In Brief

A Phase 3 clinical trial evaluating Valsartan 160 mg + nateglinide 60 mg, Valsartan 160 mg + nateglinide placebo, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 9,306 participants across 38 sites in 38 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Ecuador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Italy, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States, Uruguay
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 1, 2004
Enrollment StartJan 1, 2002
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 21.6 years ago

Interventions

Valsartan 160 mg + nateglinide 60 mgdrug

The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.

Valsartan 160 mg + nateglinide placebodrug

The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.

Nateglinide 60 mg + valsartan placebodrug

The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.

Valsartan placebo + nateglinide placebodrug

The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.