Sitagliptin Cardiovascular Outcomes Study (MK-0431-082) (TECOS)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00790205

2008_523 (Other Identifier)

2008-006719-20 (EudraCT Number)

0431-082

Details and patient eligibility

About

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.

Enrollment: 14,671 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14,671 participants in 2 patient groups, including a placebo group

Sitagliptin

Experimental group

Description:

Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.

Treatment:

Drug: Sitagliptin

Placebo

Placebo Comparator group

Description:

Placebo to sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.

Treatment:

Drug: Placebo