Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE)
The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in subjects with type 2 diabetes mellitus and acute coronary syndrome.
Diabetes Mellitus, Type 2
Acute Coronary Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome|
- Time from randomization to the occurrence of the Primary Major Adverse Cardiac Events, defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke. [ Time Frame: At first occurrence (up to 4.75 years). ] [ Designated as safety issue: No ]
- Time from randomization to the occurrence of the Secondary Major Adverse Cardiac Events defined as a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina. [ Time Frame: At first occurrence (up to 4.75 years). ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Alogliptin QD||
Alogliptin 25 mg, tablets, orally, once daily for up to 4.75 years for patients with normal or mildly impaired renal function as defined by estimated glomerular filtration rate.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 4.75 years for patients with moderately impaired renal function as defined by estimated glomerular filtration rate.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 4.75 years for patients with severely impaired renal function or end stage renal disease defined by estimated glomerular filtration rate.
|Placebo Comparator: Placebo QD||
Alogliptin placebo matching tablets, orally, once daily for up to 4.75 years.
Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use in patients with type 2 diabetes mellitus. Results from five phase 3 double-blind, placebo-controlled, 26-week studies have demonstrated that alogliptin is effective in reducing glycosylated hemoglobin as monotherapy and when added to commonly used antidiabetic agents, including sulfonylureas, metformin, thiazolidinediones, and insulin. Alogliptin is well-tolerated and associated with few adverse events.
Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus subjects who have cardiovascular disease and are at high risk for major adverse cardiac events, such as those patients who have had recent acute coronary syndrome.
This study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to Standard of Care in subjects with type 2 diabetes mellitus and acute coronary syndrome.
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|Study Director:||Medical Director Clinical Science||Takeda Global Research & Development Center, Inc.|