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 |
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).
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
We found this trial at
107
sites
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