A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PARALLEL GROUP TO DETERMINE IF, IN PATIENTS WITH TYPE 2 DIABETES WITH HIGH RISK OF CARDIOVASCULAR AND RENAL EVENTS, ALISKIREN, IN ADDITION TO CONVENTIONAL TREATMENT, REDUCES MORBIDITY AND CARDIOVASCULAR AND RENAL MORTALITY

Not Applicable

• Conditions: -E11 Non-insulin-dependent diabetes mellitus; Non-insulin-dependent diabetes mellitus; E11

• Registration Number: PER-079-07
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 87

Inclusion Criteria

• Patients with type 2 diabetes. Patients must be on current treatment with oral antidiabetics and / or insulin, or have fasting blood glucose at 7.0 mmol / l (126 mg / dL) or a blood glucose at 2 h at 11.1 mmol. / l (200 mg / dL) (WHO 2006a).
• Male or female patients> 35 years of age.
• Patients who give written informed consent to participate in the study after receiving a clear explanation of the purpose and nature of the investigation.

Exclusion Criteria

• Serum potassium> 5.0 mmol / L (in the visit immediately preceding Visit 3)
• History of any cardiovascular event (CVA, TIA, IM, unstable angina, CABG, percutaneous coronary intervention, hospitalization for 10) during the 3 months prior to Visit 1. If a patient experiences one of these events between Visit 1 and the Randomization in Visit 3, he / she must be removed from the selection phase. If appropriate, the patient can re-participate in the selection at a later stage.
• Hypertension (at Visit 3): any patient with a mean systolic blood pressure in sitting position (msSBP)> 135 and <170 mmHg or mean diastolic blood pressure in sitting position (msDBP) s 85 and <110 mmHg unless receiving treatment with at least 3 antihypertensive medications.
• Hypertension (at Visit 3): any patient with a msSBP s 170 mmHg or msDBP> 110 mmHg
• NYHA Class III and IV Congestive Heart Failure
• Concomitant treatment with two (2) or more blocking agents of the renin-angiotensin aldosterone system, ex. lECA, BRA or aldosterone antagonists.
• Unstable serum creatinine
• Cardiac block of second (II) or third (111) degree without pacemaker
• Potentially fatal concurrent arrhythmia or other uncontrolled arrhythmia
• Clinically significant valvular heart disease
• History of renal artery stenosis
• Diabetes mellitus type 1 (defined as a disease that started before the age of 35 and requires permanent treatment with insulin during the first year of diagnosis).
• Any medical or surgical condition that may significantly alter the absorption, distribution, metabolism or excretion of the study drugs, including any of the following, without being limited to these: • History of major surgery of the gastrointestinal tract such as gastrectomy, gastroenterostomy or resection intestinal (patients with previous bariatric surgery are allowed to participate> 6 months before Visit 1) • Any history of pancreatic injury, pancreatitis or evidence of deterioration / damage to pancreatic function indicated by an alteration of lipase or amyloid • Evidence of fetal disease determined by any of the following conditions: SGPT value above 3 x Upper Normal Limit (ULN) at Visit 1, history of hepatic encephalopathy, antecedent cirrhosis, esophageal varices or antecedent portocava shunt.
• History of malignant tumors other than basal cell skin cancer in the last two years.
• Any life-threatening condition with a life expectancy of less than 2 years.
• History or evidence of drug or alcohol abuse in the last 12 months
• Any concurrent medical or surgical condition that, in the opinion of the investigator, may expose the patient to a greater risk if he or she participates in the study, or that probably prevents the patient from meeting the requirements of the study or preventing the patient from completing the study.
• History of hypersensitivity to any of the study drugs or to medicines belonging to the same therapeutic class of the study drug, including a history of allergy to BRAs or to lECAs as well as antecedent or suspected contraindications to the study drugs.
• History of non-compliance with medical treatments or lack of will to comply with the study protocol.
• Use of other investigational drugs at the time of recruitment, in the 30 days or 5 half-lives prior to recruitment, or whichever is greater.
• Any condition that, in the opinion of the investigator or the Novartis medical monitor, could jeop

Study & Design

• Study Type: Interventional
• Study Design: Not specified