Summary:
A study of the cardiovascular outcomes following treatment with ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and established vascular disease. The main objective of this study is to assess the cardiovascular safety of ertugliflozin. This trial includes a pre-defined glycemic sub-study in participants receiving background insulin with or without metformin, a pre-defined glycemic sub-study in participants receiving background sulfonylurea monotherapy, and a pre-defined sub-study in participants receiving background metformin with sulfonylurea (all fully-enrolled).
Qualified Participants Must:
Be Diagnosis of T2DM in accordance with American Diabetes Association (ADA) guidelines
Have a Hemoglobin A1c (HbA1c) at the start of study participation of 7.0-10.5% (53-91 mmol/mol)
Be on stable allowable anti-hyperglycemic agents (AHA) or on no background AHA for at least 8 weeks prior to the study participation
Have a Body Mass Index (BMI) > or = to 18.0 kg/m^2
Have Evidence or a history of atherosclerosis involving the coronary, cerebral or peripheral vascular systems
Have adequate documentation of the objective evidence that the participant has established vascular disease such as investigational site's medical records, copies of such records from other institutions, or a letter from a referring physician that specifically states the diagnosis and date of the most recent occurrence of the qualifying event(s) or procedure(s).
Be Male, female not of reproductive potential, or female of reproductive potential who agrees to be abstinent from heterosexual activity or agrees to use or have their partner use 2 acceptable methods of contraception
Qualified Participants May Receive:
Compensation for time and travel.