Status:
COMPLETED
Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus, Type 2
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 patients with type 2 diabetes mellitus a...
Detailed Description
Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor developed by Takeda for use in patients with type 2 diabetes mellitus. Cardiovascular outcomes is of special interest in the type...
Eligibility Criteria
Inclusion
- Diagnosis of type 2 diabetes mellitus
- 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 participant's antidiabetic regimen includes insulin)
- Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
5380 Patients enrolled
Trial Details
Trial ID
NCT00968708
Start Date
September 1 2009
End Date
June 1 2013
Last Update
May 2 2014
Active Locations (908)
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Birmingham, Alabama, United States
2
Dothan, Alabama, United States
3
Mobile, Alabama, United States
4
Muscle Shoals, Alabama, United States