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 weeksprior to visit 1

• Treated or untreated stage 1 (according to JNC VII Guidelines) or grade 1 (accordingto 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 angiotensinreceptor blockers

• History of hypertensive encephalopathy or cerebrovascular accident less than 1 yearprior 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 ASTvalues > 2 x ULN at Visit 1, a history hepatic encephalopathy, a history of esophagealvarices, or a history of portocaval shunt

• Evidence of renal impairment as determined by any one of the following: serumcreatinine >1.25 x ULN at visit 1, a history of dialysis, or a history of nephriticsyndrome

• 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 withspermicidal or an intra-uterine device. Oral contraceptive use or dermal implants asthe only means of contraception are disallowed

• Pregnant or lactating females

• Any surgical or medical condition which, at the discretion of the investigator, placethe patient at higher risk from his/her participation in the study, or are likely toprevent the patients from complying with the requirements of the study or completingthe 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