Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)

• Status: Completed
• Trial end date: 2015-03-30
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Duke Clinical Research Institute, Oxford Diabetes Trials Unit
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Has T2DM

• Has HbA1c between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of antihyperglycemic agent(s), including insulin

• Has pre-existing cardiovascular disease

Exclusion Criteria:

• Has a history of type 1 diabetes mellitus or ketoacidosis.

• Is not able to take sitagliptin