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
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Have a Hemoglobin A1c (HbA1c) at the start of study participation of 7.0-10.5% (53-91 mmol/mol)
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Be on stable allowable anti-hyperglycemic agents (AHA) or on no background AHA for at least 8 weeks prior to the study participation
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Have a Body Mass Index (BMI) > or = to 18.0 kg/m^2
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Have Evidence or a history of atherosclerosis involving the coronary, cerebral or peripheral vascular systems
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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).
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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.