A 16-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Anti-inflammatory Actions of 320 mg Diovan in Patients With Type 2 Diabetes With and Without Coronary Artery Disease
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