Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 14671
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years. arm 2: Placebo to sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.

Interventions: intervention 1: Sitagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily. intervention 2: Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.

Protocol document: