A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDY TO EVALUATE CARDIOVASCULAR OUTCOMES OF TAK-875, 50 MG IN ADDITION TO STANDARD OF CARE IN SUBJECTS WITH TYPE 2 DIABETES AND WITH CARDIOVASCULAR DISEASE OR MULTIPLE RISK FACTORS FOR CARDIOVASCULAR EVENTS.
- Registration Number
- PER-100-12
- Lead Sponsor
- TAKEDA DEVELOPMENT CENTER AMERICAS, INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 35
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method