A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)
United States860 participantsStarted 2003-07-09
Plain-language summary
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).
Who can participate
Age range21 Years – 80 Years
SexALL
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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:
* Hyperglycaemia not requiring insulin (diet, oral hypoglycaemic agents and metformin if patients serum creatinine levels were within normal limits.)
* Hyperglycaemia requiring insulin with: no history of diabetic ketoacidosis AND with either the period between diagnosis and insulin usage \>1 year or elevated fasting or stimulated C-peptide level
* Glycosylated haemoglobin A1 (HbA1c) ≤10%
* Diabetic nephropathy, as defined by:
* serum creatinine at Screening (Visit 1) ≤265 μmol/L (3.0 mg/dL) in women and ≤283 μmol/L (3.2 mg/dL) in men
* urinary protein/creatinine ratio ≥700 mg/g (measured in spot urine) during the run-in phase (Visit 2 or Visit 5 retest)
* Hypertension at screening, as defined by either:
* Mean systolic blood pressure (SBP) \>130 mmHg and/or mean diastolic blood pressure (DBP) \>80 mmHg in untreated patients
* Patients currently receiving antihypertensive medication (i.e. medications specifically prescribed to treat hypertension)
* 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 discre…
What they're measuring
1
Change from baseline after one year of treatment in proteinuria (ratio of protein to creatinine as measure in spot urine sample).