A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus

This study is currently recruiting participants.

Verified by Novartis, September 2009

First Received: April 11, 2008 Last Updated: September 4, 2009 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00660309

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: aliskiren Drug: irbesartan	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Irbesartan Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	April 2008
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: aliskiren
2: Active Comparator	Drug: irbesartan

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660309

Contacts

Contact: Novartis

862-778-8300

Locations

United States, Massachusetts
Novartis Investigator Site	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Novartis 862-778-8300

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Novartis investigator site

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPP100A2329
Study First Received:	April 11, 2008
Last Updated:	September 4, 2009
ClinicalTrials.gov Identifier:	NCT00660309 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes mellitus
renal disease
hypertension
renal blood flow

retinal blood flow
aliskiren
irbesartan
captopril

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Diabetes Mellitus, Type 2
Irbesartan

Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010