Phase 3
Completed N=5,380
Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome
Source: ClinicalTrials.gov NCT00968708 ↗Enrolled (actual)
5,380
Serious AEs
34.6%
Results posted
Apr 2014
Primary outcomePrimary: Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) — 11.8; 11.3 percentage of participants — p=0.315
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 and acute coronary syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) |
11.8; 11.3 | 0.315 |
| SECONDARY Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE) |
13.4; 12.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT00968708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.