None listed
Conditions
Interventions
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).
Group name:Nateglinide + valsartan Type of group
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).
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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). Measure: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. Timepoints:2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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). Measure:The core phases and extension of the study is the time until the appearance of the first event of cardiovascular morbidity / mortality Timepoints:2 weeks | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Cape Verde, Chad, Chile, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Italy, Malasya, Mexico, Netherlands, Norway, Pakistan, Peru, Poland, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kindgdom, United States, Uruguay
Outcome results
None listed