The study objective was to assess the effect of single and multiple doses of aliskiren on
renal plasma flow, glomerular filtration rate and to compare the effects of single and
multiple doses of aliskiren versus captopril or irbesartan on renal blood flow, glomerular
filtration rate, and retinal blood flow in patients with type 2 diabetes mellitus.
- Hypertensive, male and females of non-child bearing potential patients, with type 2
diabetes mellitus (T2DM) (diagnosed at least 8 weeks before Screening), with or
without renal impairment; estimated glomerular filtration rate (eGFR) ≥ 40
mL/min/1.73 m^2, documented at least 3 months before the study start, aged 18-75
years with a minimum body weight of 50 kg and having an appropriate intravenous
access as determined by the study staff, able to communicate well were enrolled in
- Patients must be on a stable dose of hypoglycemic medications for at least 8 weeks
prior to the study.
- Patients must be medically able to discontinue anti- hypertensive medications for the
duration of the study.
- Patients with type 1 diabetes mellitus or uncontrolled T2DM (HbA1C> 11%), eGFR <40
mL/min/1.73 m^2 (calculated by the Modification of Diet in Renal Disease (MDRD)
formula), renal disease not caused by diabetes or hypertension, serum potassium < 3.5
or > 5.1 mEq/L, heart failure (New York Heart Association (NYHA) Class II-IV) or
history of acute/decompensated heart failure within the 6 months prior to dosing,
history of myocardial infarction, unstable angina pectoris, coronary bypass surgery,
or any percutaneous coronary intervention (PCI) during the 6 months prior to the
baseline visit, history of malignancy including leukemia and lymphoma within past
five years, hypertensive encephalopathy any time in the past or cerebrovascular
accident within the 6 months prior to the baseline visit, or with history of drug or
alcohol abuse within the 12 months prior to dosing were excluded from the study.
- Patients with glaucoma, or prior ocular surgery.
- Patients with renal disease not caused by diabetes or hypertension.
- Patients with history of clinically significant drug or atopic allergy, acute or
chronic respiratory disease, history of malignancy, or history of myocardial
infarction, unstable angina pectoris, coronary bypass surgery, or any coronary
intervention (percutaneous coronary intervention; PCI) during the 6 months prior to
- Patients who had used any prescription drugs which may affect the
renin-angiotensin-aldosterone system or with known effect on renal hemodynamics
within 2 weeks prior to dosing and during the study, over-the-counter (OTC)
medication within two (2) weeks prior to dosing,
- Any surgical or medical condition which may jeopardize the patient in case of
participation in the study.
- Participation in any clinical investigation within 4 weeks prior to the study.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to the study.
Other protocol-defined inclusion/exclusion criteria may apply.