Clinical trial NCT00464880 (phase 1/phase 2, status: completed)
Conditions: diabetes type 2
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: aliskiren
SMILES: CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C
Eligibility criteria:

        Inclusion Criteria:

          -  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:

               1. 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).

               2. 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.

        Exclusion Criteria:

          -  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%

          -  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 portacaval shunt

               -  Current treatment with cholestyramine or colestipol resins

          -  History of immunocompromise, including a positive 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 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.

        Other protocol-defined inclusion/exclusion criteria may apply.