Effects of Aliskiren, Irbesartan, and the Combination in Hypertensive Patients With Type 2 Diabetes and Diabetic Nephropathy

NCT00464880 | Completed Phase 1

• 1 other identifier: CSPP100A2243
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the reno-protective effect of renin inhibition with aliskiren as an alternative to irbesartan in type 2 diabetes patients with incipient/overt diabetic nephropathy.

Conditions

Diabetes Type 2

Keywords

Placebo-controlled study; assess the renoprotective effect of renin inhibition; Aliskiren as an alternative to irbesartan; Type 2 diabetes patients; incipient/overt diabetic nephropathy

Outcome Measures

Primary Outcomes (1)

• To investigate whether renin-inhibition using aliskiren 300 mg daily could be a treatment alternative to the angiotensin II receptor antagonist irbesartan 300 mg with an equivalent potential for reno-protection

Secondary Outcomes (2)

• To investigate whether combination therapy using aliskiren 300 mg daily and irbesartan 300 mg daily has a greater effect on reno-protection than either drug alone

• To investigate whether aliskiren, irbesartan or the combination reduce biomarkers of inflammation and cardiovascular risk

Interventions

Aliskiren DRUG

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and/or female subjects between the ages of 30-80 years with a diagnosis of type 2 diabetes (World Health Organization criteria)
• Body mass index (BMI) within the range of 20 and 32.
• Incipient or overt diabetic nephropathy (urinary albumin excretion ≥ 100 but ≤ 2000 mg/day).
• Glomerular filtration rate (GFR) ≥ 40 ml/min documented in the last 4 months prior to randomization
• To be eligible for randomization, patients must fulfill the following criteria:
• Patients on ongoing hypertensive therapy must have a blood pressure ≥ 135/85 mmHg but lower than 170/105 mmHg at Visit 2 (Day -1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to Visit 2 (run-in period).
• Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mmHg but lower than 170/105 mmHg at Visit 2 (Day -1).
• Patients must be on stable hypoglycemic medications for at least 8 weeks prior to Visit 2 (Day -1).
• Patients must be willing and medically able to discontinue all angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), aldosterone receptor antagonist and potassium sparing diuretic medications for the duration of the study.
• Female patients must be postmenopausal, have had a bilateral oophorectomy, or have been surgically sterilized or hysterectomized at least 6 months prior to screening.
• Oral body temperature within the range of 35.0-37.5 °C
• Able to provide written informed consent prior to study participation.
• Able to communicate well with the investigator and comply with the requirements of the study.

You may not qualify if:

• Severe hypertension, Grade 3 World Health Organization (WHO) classification (mean sitting diastolic blood pressure \[MSDBP\] ≥ 110 mmHg and/or mean sitting systolic blood pressure \[MSSBP\] ≤ 180 mmHg)
• Acetylsalicylic acid (ASA) treatment \> 1 g/day or regular use of nonsteroidal anti-inflammatory drugs (NSAIDs)
• Kidney disease not caused by diabetes or hypertension
• Serum potassium \< 3.5 or \> 5.1 mEq/L
• GFR \< 40 ml/min/1.73m2 as measured by the Modification of Diet in Renal Disease (MDRD) formula
• Serum albumin \< 2.0 mg/dL
• History of hypertensive encephalopathy or cerebrovascular accident in the last 12 months prior to Visit 1
• Transient ischemic cerebral attack during the 6 months prior to Visit 1
• Current diagnosis of heart failure (New York Heart Association \[NYHA\] Class II-IV)
• History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1
• Second or third degree heart block without a pacemaker
• Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
• Clinically significant valvular heart disease
• Type 1 diabetes mellitus
• Uncontrolled type II diabetes mellitus; hemoglobin subtype A1C (HbA1C) \> 11%

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

Gentofte Municipality, 2820, Denmark

Location

Related Publications (1)

• Persson F, Rossing P, Reinhard H, Juhl T, Stehouwer CD, Schalkwijk C, Danser AH, Boomsma F, Frandsen E, Parving HH. Renal effects of aliskiren compared with and in combination with irbesartan in patients with type 2 diabetes, hypertension, and albuminuria. Diabetes Care. 2009 Oct;32(10):1873-9. doi: 10.2337/dc09-0168. Epub 2009 Jul 8.

  PMID: 19587362 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Novartis

  Investigative site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 21, 2007
• First Posted: April 24, 2007
• Study Start: September 1, 2005
• Study Completion: November 1, 2007
• Last Updated: November 29, 2007

Record last verified: 2007-11

Locations

DK (1)