None listed
Conditions
Interventions
HOWEVER, THE EXPECTED STUDY DURATION IS APPROXIMATELY 6 YEARS. THE STUDY INCLUDES A SCREENING PERIOD OF UP TO 2 WEEKS
THE STUDY WILL BE CONDUCTED IN APPROXIMATELY 700 SITES GLOBALLY. APPROXIMATELY
5000 SUBJECTS WILL BE RANDOMLY ASSIGNED TO STUDY DRUG TREATMENT. THE OVERALL DURATION OF THE STUDY IS DEPENDENT ON THE
HOWEVER, SUBJECTS MAY BE ENROLLED AT ANY TIME WITHIN THE 2 WEEK SCREENING PERIOD, ONCE ALL ENTRY CRITERIA ARE CONFIRMED AND SCREENING LABORATORY RESULTS HAVE BEEN ASSESSED. TO BE ELIGIBLE FOR ENROLLME
OR THE SUBJECT MUST HAVE AT LEAST ONE OF 4 INTERMEDIATE RISK FACTORS FOR CV EVENTS: STABLE ANGINA, MULTI VESSEL CORONARY DISEASE, HISTORY OF PERCUTANEOUS CORONARY INTERVENTION, OR SPECIFIC CLINICAL CR
Sponsors
TAKEDA DEVELOPMENT CENTER AMERICAS, INC.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. IN THE OPINION OF THE INVESTIGATOR, THE SUBJECT IS CAPABLE OF UNDERSTANDING AND COMPLYING WITH PROTOCOL REQUIREMENTS, INCLUDING SCHEDULED CLINIC APPOINTMENTS. 2. THE SUBJECT OR, WHEN APPLICABLE, THE SUBJECT´S LEGALLY ACCEPTABLE REPRESENTATIVE SIGNS AND DATES A WRITTEN, INFORMED CONSENT FORM AND ANY REQUIRED PRIVACY AUTHORIZATION PRIOR TO THE INITIATION OF ANY STUDY PROCEDURES. 3. THE SUBJECT IS MALE OR FEMALE AND 18 YEARS OF AGE OR OLDER. 4. THE SUBJECT HAS A DIAGNOSIS OF T2DM. 5. THE SUBJECT HAS AN HBALC LEVEL BETWEEN 7.0% AND 10.5%, INCLUSIVE, AT SCREENING. HBALC TESTING MAY BE REPEATED ONCE DURING SCREENING. 6. THE SUBJECT MEETS AT LEAST ONE (1) OF THE FOLLOWING THREE (3) HIGH RISK CATEGORIES (A-C): A) A DOCUMENTED HISTORY OF MYOCARDIAL INFARCTION (MI) OCCURRING NO LESS THAN 2 MONTHS (60 DAYS) AND NO GREATER THAN 24 MONTHS PRIOR TO SCREENING. B) DOCUMENTED SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE (PAD) (AT LEAST ONE (1) OF THE FOLLOWING THREE (3) CRITERIA MUST BE SATISFIED): A. CURRENT INTERMITTENT CLAUDICATION TOGETHER WITH DOCUMENTED ANKLE-BRACHIAL INDEX ≤ 0.85. B. HISTORY OF INTERMITTENT CLAUDICATION OR RESTING LIMB ISCHEMIA TOGETHER WITH PREVIOUS RELATED VASCULAR INTERVENTION (AMPUTATION FOR ARTERIAL DISEASE, PERIPHERAL BYPASS, OR HISTORY OF ANGIOPLASTY/STENTING). C. HISTORY OF SYMPTOMATIC CAROTID ARTERY DISEASE (REQUIRING REVASCULARIZATION WITH CAROTID ENDARTERECTOMY (CEA) OR STENTING).
Exclusion criteria
Exclusion criteria: 1. THE SUBJECT HAS RECEIVED ANY INVESTIGATIONAL MEDICATION WITHIN 30 DAYS PRIOR TO SCREENING OR ANY INVESTIGATIONAL ANTIDIABETIC MEDICATION OR EXCLUDED MEDICATIONS LISTED IN SECTION 7.3 WITHIN 3 MONTHS PRIOR TO SCREENING. 2. THE SUBJECT HAS BEEN RANDOMIZED INTO A PREVIOUS TAK-875 STUDY. 3. THE SUBJECT IS AN IMMEDIATE FAMILY MEMBER, STUDY SITE EMPLOYEE, OR IS IN A DEPENDANT RELATIONSHIP WITH A STUDY SITE EMPLOYEE WHO IS INVOLVED IN CONDUCT OF THIS STUDY (EG, SPOUSE, PARENT, BIOLOGICAL OR LEGALLY ADOPTED CHILD, OR SIBLING) OR MAY CONSENT UNDER DURESS 4. THE SUBJECT IS DIAGNOSED WITH TYPE 1 DIABETES MELLITUS OR LATENT AUTOIMMUNE DIABETES IN ADULTS. 5. THE SUBJECT IS HEMODYNAMICALLY UNSTABLE, INCLUDING SEVERE HEART FAILURE (NEW YORK HEART ASSOCIATION CLASS IV) AT SCREENING. 6. THE SUBJECT IS HOSPITALIZED AT THE SCREENING VISIT FOR THE EVENT ASSOCIATED WITH THE CV INCLUSION CRITERIA. (SUBJECTS WHO HAVE BEEN DISCHARGED FROM AN ACUTE HOSPITAL TO A CARDIAC REHABILITATION CENTER OR NURSING HOME AT THE TIME OF THE SCREENING VISIT OR RANDOMIZATION VISIT ARE NOT EXCLUDED). 7. THE SUBJECT HAS ALT AND/OR ASPARTATE AMINOTRANSFERASE (AST) LEVELS >3.0X LTLN AT SCREENING. 8. THE SUBJECT HAS A TOTAL BILIRUBIN LEVEL >ULN AT SCREENING. EXCEPTION: IF A SUBJECT HAS DOCUMENTED GILBERT´S SYNDROME, THE SUBJECT WILL BE ALLOWED WITH AN ELEVATED BILIRUBIN LEVEL PER THE INVESTIGATOR´S DISCRETION.
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Estonia, France, Germany, Hungary, Israel, Italy, Korea North, Lithuania, Malasya, Mexico, New Zealand, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Taiwan, Thailand, Ukraine, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed