Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)
Status:
Completed
Trial end date:
2015-03-30
Target enrollment:
Participant gender:
Summary
This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment
with sitagliptin used as part of usual care compared to usual care without sitagliptin in
participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV)
disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.
Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to
usual care without sitagliptin with regard to the risk of developing a confirmed event in the
primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If
hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care,
is superior to usual care without sitagliptin with regard to the risk of developing a
confirmed event in the primary CV composite endpoint.
Phase:
Phase 3
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Collaborator:
Duke Clinical Research Institute, Oxford Diabetes Trials Unit