Diabetes type 2
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For full list, please refer to the protocol 1. Patients with type 2 diabetes according to WHO definition 2. Male or female patients = 35 years of age. 3. Patients who provide written informed consent to participate in the study after the purpose and nature of the investigation have been clearly explained to them 4. Patients with at least one of the following : • Persistent macroalbuminuria (UACR = 200 mg/g [or 22.6 mg/mmol] in at least two out of three first morning void urine samples) • Persistent microalbuminuria (UACR = 20 mg/g and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For full list, please refer to the protocol 1. eGFR 5.0 mmol/L (at the visit directly preceding Visit 3). If the investigator has reason to believe the serum potassium result is invalid, one repeat test may be done. 3. History of any cardiovascular event (stroke, transient ischemic cerebral attack, MI, unstable angina, CABG, percutaneous coronary intervention, hospitalization due to HF) during the 3 months prior to Visit 1. • If a patient experiences such an event between Visit 1 and randomization at Visit 3, he/she should be withdrawn from the screening phase. If suitable, the patient can be re-screened at a later stage (see Section 5.2). 4. Hypertension (at Visit 3): any patient with a mean sitting systolic blood pressure (msSBP) = 135 mmHg or msDBP = 85 mmHg should be excluded unless treated with at least 3 anti-hypertensive medications; even if treated with 3 or more anti-hypertensive agents, a patient with msSBP = 170 mmHg or msDBP = 110 mmHg must be excluded. 5. Congestive heart failure NYHA class III or IV. 6. Concomitant treatment with two (2) or more renin-angiotensin-aldosterone system blocking agents apart from the study drug, e.g. ACEI, ARB or aldosterone-antagonist or any renin inhibitor. 7. Unstable serum creatinine: defined as = 20% difference between 2 consecutive serum creatinine measurements before Visit 3. A maximum of 4 measurements will be allowed. If the difference between the first 2 measurements is = 20% of the higher value, a third measurement should be performed at the next visit. If the difference between the last 2 measurements is = 20% of the higher value, at fourth measurement should be performed at the next visit. If the difference between the last two measurements performed is = 20%, the patient is excluded. 8. Second or third degree heart block without a pacemaker. 9. Concurrent potentially life threatening arrhythmia or other uncontrolled arrhythmia. 10. Clinically significant valvular heart disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether aliskiren, compared to placebo, when added to conventional treatment, delays the occurrence of cardiovascular and renal complications in patients with type 2 diabetes at high risk for cardiovascular and renal events. For details on definition of cardiovascular or renal complications, please refer to the protocol. ;Secondary Objective: • To determine whether aliskiren, compared to placebo, when added to conventional treatment delays the occurrence of cardiovascular complications. For details on definition of cardiovascular complications, please refer to the protocol. • To determine whether aliskiren, compared to placebo, when added to conventional treatment delays the occurrence of renal complications. For details on definition of renal complications, please refer to the protocol. Exploratory objectives: For full list, please refer to the protocol. ;Primary end point(s): The primary efficacy variable is the time to the first event of the primary composite endpoint consisting of CV death, resuscitated sudden death, non-fatal MI, non-fatal stroke, unplanned hospitalization for HF, onset of ESRD, renal death, and doubling of serum creatinine concentration from baseline, sustained for at least for one month and above the upper limit of normal. It will be calculated in days for each patient as the difference between the date of the first event or censoring date if no event occurs and the date of randomization visit (day 1) plus one. The primary composite endpoint will be derived based on the adjudicated events. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Portugal, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed