A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Aliskiren; Irbesartan; Captopril
Intervention description: Aliskiren 300 mg tablets; Irbesartan 300 mg tablets; Captopril 25 mg tablet
Intervention MeSH terms: Irbesartan; Captopril
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; renal disease; hypertension; renal blood flow; retinal blood flow; aliskiren; irbesartan; captopril

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 the study.

          -  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.

        Exclusion Criteria:

          -  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
             the study.

          -  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.