Anti-Inflammatory Actions of Valsartan in Patients With Type 2 Diabetes Mellitus

Inclusion Criteria:

• Male or female patients between 30 and 80 years old, inclusive
• Controlled type 2 Diabetes Mellitus on stable treatment at least during the 4 weeks prior to visit 1
• Treated or untreated stage 1 (according to JNC VII Guidelines) or grade 1 (according to ESH/ESC 2003 Guidelines) hypertensive patients
• For one stratum: angiographically proven CAD
• Signed informed consent prior to any study procedure

Exclusion Criteria:

• Hypertension classified as stage 2 (or grade 2) or higher
• Normotensive patients, i.e. patients who do not have a history of high blood pressure, and who are not receiving any antihypertensive medication
• Treatment with more than 2 antihypertensive medications
• Current treatment with ARBs
• Glycated hemoglobin (HbA1c) >8.5% at Visit 1
• Current treatment with glitazones
• Myocardial infarction less than 3 months prior to Visit 1
• Total cholesterol >7.8 mmol/l
• Past diagnosis of any systemic inflammatory disease
• Known or suspected contraindications, including history of allergy to angiotensin receptor blockers
• History of hypertensive encephalopathy or cerebrovascular accident less than 1 year prior to Visit 1
• Known Keith-Wagener grade III or IV hypertensive retinopathy
• History of heart failure
• Second or third degree heart block without a pacemaker
• Concomitant unstable angina pectoris
• Concurrent potential life threatening arrhythmia or symptomatic arrhythmia
• Clinically significant valvular heart disease
• Evidence of hepatic disease as determined by any one of the following: ALT or AST values > 2 x ULN at Visit 1, a history hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
• Evidence of renal impairment as determined by any one of the following: serum creatinine >1.25 x ULN at visit 1, a history of dialysis, or a history of nephritic syndrome
• Sodium value <132 mmol/L at Visit 1
• Serum potassium values <3.5 mmol/L or >5.5 mmol/L at visit 1
• Any surgical or medical condition which might alter the absorption, distribution, metabolism, excretion of any drug
• Female patients who are not either post-menopausal for one year of surgically sterile, and who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Oral contraceptive use or dermal implants as the only means of contraception are disallowed
• Pregnant or lactating females
• Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patients from complying with the requirements of the study or completing the trial period
• History of malignancy including leukemia and lymphoma within 5 years prior to Visit 1
• History of any severe, life threatening disease within the past five years
• Any previous history of a systemic autoimmune disease
• History of drug or alcohol abuse within the last two years
• Participation in any investigational drug trial within one month prior to visit 1