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

NCT ID: NCT00660309

Last Updated: 2012-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-12-31

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; renal disease; hypertension; renal blood flow; retinal blood flow; aliskiren; irbesartan; captopril

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Aliskiren

On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.

Group Type: EXPERIMENTAL

Aliskiren

Intervention Type: DRUG

Aliskiren 300 mg tablets

Captopril

Intervention Type: DRUG

Captopril 25 mg tablet

Irbesartan

On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.

Group Type: ACTIVE_COMPARATOR

Irbesartan

Intervention Type: DRUG

Irbesartan 300 mg tablets

Captopril

Intervention Type: DRUG

Captopril 25 mg tablet

Interventions

Aliskiren

Aliskiren 300 mg tablets

Intervention Type: DRUG

Irbesartan

Irbesartan 300 mg tablets

Intervention Type: DRUG

Captopril

Captopril 25 mg tablet

Intervention Type: DRUG

Other Intervention Names

SPP100

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis investigator site

Locations

Novartis Investigator Site

Boston, Massachusetts, United States

Countries

United States

References

Hollenberg NK, Fisher ND, Nussberger J, Moukarbel GV, Barkoudah E, Danser AH. Renal responses to three types of renin-angiotensin system blockers in patients with diabetes mellitus on a high-salt diet: a need for higher doses in diabetic patients? J Hypertens. 2011 Dec;29(12):2454-61. doi: 10.1097/HJH.0b013e32834c627a.

Reference Type: DERIVED

PMID: 22002336 (View on PubMed)

Other Identifiers

CSPP100A2329

Identifier Type: -

Identifier Source: org_study_id