Phase 3
N=9,306
Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00097786 ↗Enrolled (actual)
9,306
Serious AEs
45.2%
Results posted
May 2011
Primary outcome: Primary: Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan — 33.1; 36.8 Percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Valsartan 160 mg + nateglinide 60 mg (Drug); Valsartan 160 mg + nateglinide placebo (Drug); Nateglinide 60 mg + valsartan placebo (Drug); Valsartan placebo + nateglinide placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan |
33.1; 36.8 | — |
| PRIMARY Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan |
14.5; 14.8 | — |
| PRIMARY Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan |
8.1; 8.1 | — |
| PRIMARY Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide |
36.0; 33.9 | — |
| PRIMARY Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide |
14.2; 15.2 | — |
| PRIMARY Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide |
7.9; 8.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults
- Impaired glucose tolerance
- Age dependent risk factors
Exclusion Criteria
- Frank diabetes
For detailed information, call contact person.
Data sourced from ClinicalTrials.gov (NCT00097786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.