MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROL, WITH FORCED TITRATION, FACTORIAL DESIGN OF 2 X 2, TO EVALUATE THE EFFICACY AND SAFETY OF THE LONG-TERM ADMINISTRATION OF NATEGLINIDA AND VALSARTAN IN THE PREVENTION OF DIABETES AND DISORDERS CARDIOVASCULARS IN SUBJECTS WITH GLUCOSE DEFICIENT TOLERANCE (IGT).
- Conditions
- -E149 Unspecified diabetes mellitus, without complicationsUnspecified diabetes mellitus, without complicationsE149
- Registration Number
- PER-008-02
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method