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

Use our guide to learn which trials are right for you!

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
We found this trial at
107
sites
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
1494
mi
from 91732
Alexandria, LA
Click here to add this to my saved trials
1819
mi
from 91732
Anderson, IN
Click here to add this to my saved trials
2002
mi
from 91732
Asheville, NC
Click here to add this to my saved trials
1780
mi
from 91732
Avon, IN
Click here to add this to my saved trials
1254
mi
from 91732
Bartlesville, OK
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
2309
mi
from 91732
Boynton Beach, FL
Click here to add this to my saved trials
1562
mi
from 91732
Bridgeton, MO
Click here to add this to my saved trials
2400
mi
from 91732
Bridgewater, NJ
Click here to add this to my saved trials
2436
mi
from 91732
Bronx, NY
Click here to add this to my saved trials
2434
mi
from 91732
Brooklyn, NY
Click here to add this to my saved trials
Buenos Aires,
Phone: 54 11 4796 8200
6113
mi
from 91732
Buenos Aires,
Click here to add this to my saved trials
1867
mi
from 91732
Cadillac, MI
Click here to add this to my saved trials
2245
mi
from 91732
Calabash, NC
Click here to add this to my saved trials
356
mi
from 91732
Chandler, AZ
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
2117
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
804
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
1959
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
1293
mi
from 91732
Corpus Christi, TX
Click here to add this to my saved trials
1303
mi
from 91732
Council Bluffs, IA
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
2304
mi
from 91732
Delray Beach, FL
Click here to add this to my saved trials
1223
mi
from 91732
Desoto, TX
Click here to add this to my saved trials
1966
mi
from 91732
Detroit, MI
Click here to add this to my saved trials
2422
mi
from 91732
Elizabeth, NJ
Click here to add this to my saved trials
1715
mi
from 91732
Evansville, IN
Click here to add this to my saved trials
Fall River, Massachusetts 02720
2576
mi
from 91732
Fall River, MA
Click here to add this to my saved trials
1400
mi
from 91732
Fargo, ND
Click here to add this to my saved trials
1935
mi
from 91732
Flint, MI
Click here to add this to my saved trials
1190
mi
from 91732
Fort Sam Houston, TX
Click here to add this to my saved trials
1797
mi
from 91732
Franklin, IN
Click here to add this to my saved trials
363
mi
from 91732
Gilbert, AZ
Click here to add this to my saved trials
14
mi
from 91732
Glendale, AZ
Click here to add this to my saved trials
2445
mi
from 91732
Glens Falls, NY
Click here to add this to my saved trials
1745
mi
from 91732
Green Bay, WI
Click here to add this to my saved trials
1623
mi
from 91732
Hammond, LA
Click here to add this to my saved trials
2576
mi
from 91732
Haverhill, MA
Click here to add this to my saved trials
1564
mi
from 91732
Hazelwood, MO
Click here to add this to my saved trials
2315
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
Hopewell Junction, New York 12533
2439
mi
from 91732
Hopewell Junction, NY
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
2127
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
1331
mi
from 91732
Katy, TX
Click here to add this to my saved trials
1727
mi
from 91732
Kenosha, WI
Click here to add this to my saved trials
1898
mi
from 91732
Kettering, OH
Click here to add this to my saved trials
2367
mi
from 91732
Lansdale, PA
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33313
2310
mi
from 91732
Lauderdale Lakes, FL
Click here to add this to my saved trials
1939
mi
from 91732
Lawrenceville, GA
Click here to add this to my saved trials
2056
mi
from 91732
Lenoir, NC
Click here to add this to my saved trials
2615
mi
from 91732
Lewiston, ME
Click here to add this to my saved trials
1210
mi
from 91732
Lewisville, TX
Click here to add this to my saved trials
1463
mi
from 91732
Little Rock, AR
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
1813
mi
from 91732
Louisville, KY
Click here to add this to my saved trials
1978
mi
from 91732
Macon, GA
Click here to add this to my saved trials
1654
mi
from 91732
Madison, WI
Click here to add this to my saved trials
2256
mi
from 91732
Manassas, VA
Click here to add this to my saved trials
1955
mi
from 91732
Marion, OH
Click here to add this to my saved trials
1931
mi
from 91732
Maumee, OH
Click here to add this to my saved trials
1648
mi
from 91732
Metairie, LA
Click here to add this to my saved trials
2570
mi
from 91732
Methuen, MA
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
910
mi
from 91732
Missoula, MT
Click here to add this to my saved trials
Moncks Corner, South Carolina 29461
2174
mi
from 91732
Moncks Corner, SC
Click here to add this to my saved trials
2049
mi
from 91732
Morganton, NC
Click here to add this to my saved trials
565
mi
from 91732
Murray, UT
Click here to add this to my saved trials
2433
mi
from 91732
Neptune, NJ
Click here to add this to my saved trials
2429
mi
from 91732
New Windsor, NY
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
North Hollywood, California 91606
21
mi
from 91732
North Hollywood, CA
Click here to add this to my saved trials
2314
mi
from 91732
Oakland Park, FL
Click here to add this to my saved trials
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
2182
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
2183
mi
from 91732
Ormond Beach, FL
Click here to add this to my saved trials
2117
mi
from 91732
Palm Harbor, FL
Click here to add this to my saved trials
2387
mi
from 91732
Penndel, PA
Click here to add this to my saved trials
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
2153
mi
from 91732
Plant City, FL
Click here to add this to my saved trials
2214
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
2267
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
2446
mi
from 91732
Rosedale, NY
Click here to add this to my saved trials
1930
mi
from 91732
Saginaw, MI
Click here to add this to my saved trials
2126
mi
from 91732
Salem, VA
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
24
mi
from 91732
Santa Ana, CA
Click here to add this to my saved trials
397
mi
from 91732
Santa Rosa, CA
Click here to add this to my saved trials
2148
mi
from 91732
Sarasota, FL
Click here to add this to my saved trials
1198
mi
from 91732
Schertz, TX
Click here to add this to my saved trials
939
mi
from 91732
Spokane, WA
Click here to add this to my saved trials
Thousand Oaks, California 91360
50
mi
from 91732
Thousand Oaks, CA
Click here to add this to my saved trials
24
mi
from 91732
Torrance, CA
Click here to add this to my saved trials
427
mi
from 91732
Tucson, AZ
Click here to add this to my saved trials
25
mi
from 91732
Tustin, CA
Click here to add this to my saved trials
1756
mi
from 91732
Valparaiso, IN
Click here to add this to my saved trials
70
mi
from 91732
Ventura, CA
Click here to add this to my saved trials