Time Course of the Antiproteinuric and Blood Pressure Lowering Effects After Initiation of Renin Inhibition With Aliskiren in Type 2 Diabetes
This study has been completed.
Information provided by:
First received: April 16, 2007
Last updated: June 21, 2007
Last verified: June 2007
This study will evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.
Diabetes Type 2
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label, One-Period, One-Treatment Study to Evaluate the Time Course of the Antiproteinuric and Blood Pressure Lowering Effects After Initiation of Renin Inhibition With Aliskiren in Type 2 Diabetes Suffering From Incipient and/or Established Nephropathy
Primary Outcome Measures:
- To evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.
Secondary Outcome Measures:
- To measure blood pressure changes over time during the onset and offset of effect.
- To investigate whether there is a change on biomarkers of inflammation and cardiovascular risk.
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||30 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male and/or female patients from 30-80 years of age with a diagnosis of Type 2 diabetes (WHO criteria).
- Incipient and established diabetic nephropathy (urinary albumin excretion ≥ 100 mg/day but ≤ 2000 mg/day).
- Glomerular filtration rate (GFR) ≥ 40 ml/min (estimated using Modification of Diet in Renal Disease (MDRD) formula) in the last 4 months.
- Female patients must be postmenopausal or must have had a bilateral oophorectomy or must have been surgically sterilized or hysterectomized at least 6 months prior to screening.
- To be eligible patients must fulfill the following criteria: Patients on ongoing hypertensive therapy must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at baseline (Day -1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to baseline (Day -1).; Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at baseline (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.
- Oral body temperature within the range 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.
- Severe Hypertension Grade 3 WHO classification (Mean Sitting Diastolic Blood Pressure (MSDBP) 110 mmHg and/or Mean Sitting Systolic Blood Pressure MSSBP 180 mmHg)
- Acetylsalicyclic acid (ASA) treatment >1g/day or regular use of Non steroidal anti-inflammatory drug (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 MDRD formula
- Serum albumin < 2.0mg/dL
- History of hypertensive encephalopathy or cerebrovascular accident at any time prior to Visit1.
- 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 (Hemaglobin subtype A1C (HbA1C) >11 %)
- History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- Significant illness within the two weeks prior to dosing.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:
History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
-Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1 Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1.
Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase Evidence of hepatic disease, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- Current treatment with cholestyramine or cholestipol resins
- History of immunocompromise, including a positive HIV test result.
- History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- History of drug or alcohol abuse within the 12 months prior to dosing.
- Persons directly involved in the execution of this protocol.
- Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- Known or suspected contraindications to the study medications, including history of allergy to Angiotensin converting enzyme (ACE) inhibitors and/or to thiazide diuretics or other sulfonamide derived drug
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
- Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol.
- Patients who previously participated in any Aliskiren study.
- Pregnant or nursing woman.
Other protocol-defined inclusion/exclusion criteria may apply
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461136
|Gentofte, Denmark, 2820 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 16, 2007
||June 21, 2007
||Denmark: Danish Medicines Agency
Keywords provided by Novartis:
initiation of renin inhibition
Aliskiren in Type 2 diabetes
incipient and/or established nephropathy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases