Official Title: “An Open-Label, Randomized, Parallel-Group Study to Evaluate the Acute and Steady-State Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus”

The study objective is to compare the effects of single and multiple doses of the oral direct renin inhibitor aliskiren and the angiotensin receptor antagonist irbesartan on renal blood flow, glomerular filtration rate, and retinal blood flow in patients with type 2 diabetes mellitus.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• Drug: aliskiren
• Drug: irbesartan

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Renal blood flow and glomerular filtration rate at baseline, after 1 and 14 days of treatment with aliskiren or irbesartan and after a single dose of captopril (an angiotensin converting enzyme inhibitor and positive control)
  • Time Frame: 1 and 14 days of treament
    Safety Issue?: No

Secondary Measures

• Retinal blood flow at baseline, after 14 days of treatment with aliskiren or irbesartan, after a singe dose of captopril Plasma levels of renin system biomarkers (renin, pro-renin, angiotensin 1, angiotensin 2, angiotensinogen, and aldosterone)
  • Time Frame: 14 days of treatment
    Safety Issue?: No

Inclusion Criteria:

• Patients must have been diagnosed with type 2 diabetes mellitus at least 6 months before the study, with history of hypertension or newly diagnosed hypertension.
• 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.
• Female patients must be postmenopausal or surgically sterilized

Exclusion Criteria:

• Patients with Type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus.
• Patients with glaucoma, or prior ocular surgery.
• Patients with renal disease not caused by diabetes or hypertension.
• Patients with heart failure or high serum potassium.
• 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 (PCI) during the 6 months prior to the study.
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Principal Investigator Novartis investigator site  

Overall Contact: Novartis 862-778-8300 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00660309

Study ID Number: CSPP100A2329

ClinicalTrials.gov Identifier: NCT00660309

Health Authority: United States: Food and Drug Administration