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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Cardiovascular Abnormalities
Location: United States, FL
EXAMINE- This study is to evaluate the cardiovascular outcomes of alogliptin, once daily, compared with placebo, in addition to stand of care, in subjects with Type 2 Diabetes Mellitus and Acute Coronary Syndrome.
This study is to evaluate the cardiovascular outcomes of alogliptin, once daily, compared with placebo, in addition to stand of care, in subjects with Type 2 Diabetes Mellitus and Acute Coronary Syndrome.
Patient Inclusion Criteria: Men and women with a diagnosis of Type 2 Diabetes who are eiher receiving monotherapy or combination antidiabetic therapy (with the exception of a DPP-4 inhibitor or GLP-1 analogue). Subjects must have an HbA1c level between 6.5% and 11% inclusive, at Screening (between 7% and 9.0% inclusive, if the subjects antidiabetic regimen includes insulin). In addition, subjects must haf a diagnosis of ACS within 15-90 days prior to randomization.
Patient Exclusion Criteria: Subject has signs or is diagnosed with type 1 diabetes mellitus or latent autoimmune diabetes in adults. Subject is currently receiving a GLP-1 analogue for glycemic control T2DM at Screening. Subject has received a DPP-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening. Subject has any hemodynamically unstable CV disorder including heart failure, angina, cardiac arrhythmias, critical valvular heart disease, and severe hypertension at Screening.
Miriam Johnson, LPN, Clinical Research Coordinator
Holy Cross Jim Moran Heart and Vascular Research Institute
1951 NE 47th Street
Fort Lauderdale, FL 33308
Phone: (954) 229-8400
Fax: (954) 229-8597
If you would like to learn more about participating in this study, please send an email message using the form below.
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