Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)



Status:Active, not recruiting
Conditions:Cardiology, Diabetes, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:40 - Any
Updated:3/29/2019
Start Date:November 4, 2013
End Date:September 11, 2019

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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes Following Treatment With Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus and Established Vascular Disease, The VERTIS CV Study

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).


Inclusion Criteria:

- Diagnosis of T2DM in accordance with American Diabetes Association (ADA) guidelines

- Hemoglobin A1c (HbA1c) at the start of study participation of 7.0-10.5% (53-91
mmol/mol)

- On stable allowable anti-hyperglycemic agents (AHA) or on no background AHA for at
least 8 weeks prior to the study participation

- Body Mass Index (BMI) > or = to 18.0 kg/m^2

- Evidence or a history of atherosclerosis involving the coronary, cerebral or
peripheral vascular systems

- There is 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).

- Male, female not or 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

Exclusion Criteria:

- Previous randomization into a trial of ertugliflozin

- Experiencing a cardiovascular event (myocardial infarction or stroke) or undergoing
coronary angioplasty or peripheral intervention procedure between the Screening Visit
and randomization

- Undergoing any cardiovascular surgery (valvular surgery) within 3 months of study
participation

- Planned revascularization or peripheral intervention procedure or other cardiovascular
surgery

- New York Heart Association (NYHA) IV heart failure at study participation

- History of type 1 diabetes mellitus or a history of ketoacidosis
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