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Therapeutic Areas: Endocrinology | Family Medicine
Disease Category: Diabetes Mellitus, Type 2
Location: United States, PA
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
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.
Patient Inclusion Criteria:
- Diagnosis of type 2 diabetes mellitus
- Subject is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the subject's antidiabetic regimen includes insulin)
- iagnosis of acute coronary syndrome within 15 to 90 days prior to randomization
Patient Exclusion Criteria:
- Signs of type 1 diabetes mellitus
- Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
- Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening
Julia Benton, RN, CCRC, site manager
Blair Medical Associates, Inc. Clinical Trials Dept.
Blair Medical Associates, Inc. Station Medical Center
1414 Ninth Ave.
Altoona, PA 16602
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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