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A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg, another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR) 100 mg in reducing the level of urinary protein (indicative of improved kidney function).
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Inclusion criteria
Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Age 21-80 years
Clinical history of type 2 diabetes mellitus, as defined by either:
Glycosylated haemoglobin A1 (HbA1c) ≤10%
Diabetic nephropathy, as defined by:
Hypertension at screening, as defined by either:
Ability to stop current antihypertensive therapy with Angiotensin Converting Enzyme Inhibitor (ACE-Is), Angiotensin Receptor Blockers (ARBs) and direct vasodilators, and to stop chronic immunosuppressive therapy and current therapy with metformin without risk to the patient (Investigator's discretion).
All female patients had to have negative results from the urine pregnancy test (UPT) at Visits 1 and 6 in order to be able to continue in the study.
Exclusion criteria
Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:
Type 1 diabetes mellitus
Increase of serum creatinine >35% between Visit 1 (Screening) and Visit 5. If creatinine was increased >35% at Visit 5, the measurement was to be repeated within five calendar days and if the increase was confirmed, the patient had to be excluded from the trial for safety reasons.
Non-diabetic renal disease
Congestive heart failure (New York Heart Association functional class III or IV)
Unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous coronary intervention within the last three months prior to signing the informed consent form
Stroke or transient ischaemic attack within the last six months prior to signing the informed consent form
Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
Further exclusion criteria apply
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Data sourced from clinicaltrials.gov
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