A clinical trial to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality

• Conditions: Type 2 diabetes mellitusCardiovascular diseaseMicro-albuminuriaMacro-albuminuriaReduced estimated glomerular filtration rate; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2007-000860-25-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-06
• Last Update Posted: 4 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8600

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 < 200 mg/g [or UACR =
2.26 mg/mmol and < 22.6 mg/mmol] in at least two of three morning void
urines) and a mean eGFR < 60 mL/min/1.73m2 calculated by the abbreviated
MDRD study equation (Levey, et al 2000) (mean of two consecutive
measurements)
• A history of cardiovascular disease and a mean eGFR < 60 mL/min/1.73m2
History of cardiovascular disease is defined as at least one of the following:
• Previous MI (previous hospitalization with a discharge diagnosis of MI)
• Previous stroke (previous hospitalization with a discharge diagnosis of
stroke. A previous transient ischemic attack -TIA- is not sufficient to fulfill this
criterion)
• HF (previous hospitalization with a discharge diagnosis of HF, with or without
preserved ejection fraction)
• Coronary artery disease (CAD) defined as follows:
• History of percutaneous coronary intervention [PCI]
• Coronary artery bypass graft [CABG]
• Angiographically proven stenosis = 50% in at least one major epicardial
coronary artery
5. Patient's concomitant treatment must include an ACEI or an ARB. Patient should
be on conventional therapy according to national guidelines. Patients must not
have had any adjustments to their concomitant antihypertensive therapy for at
least four (4) weeks prior to randomization (Visit 3).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3977
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4295

Exclusion Criteria

- Type 1 diabetes mellitus
- Cardiovascular event or procedure = 3 months prior to Visit 1
- Unstable serum creatinine
- Hypertension: Mean sitting systolic blood pressure (msSBP) = 135 and
< 170 mmHg or Mean sitting diastolic blood pressure (msDBP) = 85 and
< 110 mmHg unless treated with at least 3 antihypertensive medications
- Hypertension msSBP = 170 or msDBP = 110 mmHg
- Baseline Serum Potassium > 5.0 mmol/L
- Patients who are treated with two renin-angiotensin-aldosteronesystem-
blockers
- Patients with NYHA class III or IV heart failure
- Known renal artery stenosis
- Previous randomization into the AVOID trial (CSPP100C2201)
- Specific to the safety follow-up period: Aliskiren or aliskiren-containing
fixed combination products must not be used in combination with
angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor
blocker (ARB) in patients with diabetes.
- Specific to the safety follow-up period: Participation in another clinical
trial, whether or not on investigational drug

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified