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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01986881
First Posted: November 19, 2013
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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).

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Ertugliflozin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) [ Time Frame: Up to 6.1 years ]

Secondary Outcome Measures:
  • Time to First Occurrence of Cardiovascular Death or Hospitalization for Heart Failure [ Time Frame: Up to 6.1 years ]
  • Time to Occurrence of Cardiovascular Death [ Time Frame: Up to 6.1 years ]
  • Time to First Occurrence of the Composite of Renal Death, Renal Dialysis/Transplant, or ≥2x Increase in Baseline Serum Creatinine [ Time Frame: Up to 6.1 years ]
  • Time to First Occurrence of Mace Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) [ Time Frame: Up to 6.1 years ]
  • Time to First Occurrence of Fatal or Non-fatal Stroke [ Time Frame: Up to 6.1 years ]
  • Time to First Occurrence of Hospitalization for Heart Failure [ Time Frame: Up to 6.1 years ]
  • Time to First Occurrence of Individual Components of MACE (Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke) [ Time Frame: Up to 6.1 years ]
  • Time to Occurrence of All-cause Mortality [ Time Frame: Up to 6.1 years ]
  • Time to Occurrence of All MACE Events (not censored at the time of the first event) [ Time Frame: Up to 6.1 years ]
  • Time to Occurrence of All Cardiovascular Death or Hospitalizations for Heart Failure (Not Censored at the Time of the First Event) [ Time Frame: Up to 6.1 years ]
  • Change from Baseline in Hemoglobin A1C (HbA1C) [ Time Frame: Up to 6.1 years ]
  • Change from Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Up to 6.1 years ]
  • Time to the first Occurrence of a Participant Receiving Glycemic Rescue Therapy (Up to 18 weeks) [ Time Frame: Up to 18 weeks ]
  • Time to Initiation of Insulin for Participants Not on Insulin at Randomization [ Time Frame: Up to 6.1 years ]
  • Change from Baseline in Insulin Dose at the End of Study (up to 6.1 years) [ Time Frame: Up to 6.1 years ]
  • Change from Baseline in Body Weight [ Time Frame: Up to 6.1 years ]
  • Number of Participants with a HbA1C <7% [ Time Frame: Up to 6.1 years ]
  • Change from Baseline in Systolic Blood Pressure [ Time Frame: Up to 6.1 years ]
  • Change from Baseline in Diastolic Blood Pressure [ Time Frame: Up to 6.1 years ]
  • Number of Participants Experiencing and Adverse Event (AE) [ Time Frame: Up to 6.1 years ]
  • Number of Participants Discontinuing Study Treatment Due to An AE [ Time Frame: Up to 6.1 years ]
  • Time to First Occurrence of any of the Components of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hosptialization for Unstable Angina [ Time Frame: Up to 6.1 years ]
  • Change from Baseline in HbA1C at Week 18 [ Time Frame: Baseline and Week 18 ]
  • Change from Baseline in Body Weight at Week 18 [ Time Frame: Baseline and Week 18 ]
  • Number of Participants with a HbA1C <7% at Week 18 [ Time Frame: Week 18 ]
  • Change from Baseline in Systolic Blood Pressure at Week 18 [ Time Frame: Baseline and Week 18 ]
  • Change from Baseline in Diastolic Blood Pressure at Week 18 [ Time Frame: Baseline and Week 18 ]
  • Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction [ Time Frame: Up to 6.1 years ]

Estimated Enrollment: 8000
Actual Study Start Date: November 4, 2013
Estimated Study Completion Date: October 31, 2019
Estimated Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ertugliflozin, 15 mg
Ertugliflozin 15 mg administered orally once daily for up to 6.1 years
Drug: Ertugliflozin
Oral, once daily, up to 6.1 years
Other Name: MK-8835
Experimental: Ertugliflozin, 5 mg
Ertugliflozin 5 mg administered orally once daily for up to 6.1 years
Drug: Ertugliflozin
Oral, once daily, up to 6.1 years
Other Name: MK-8835
Drug: Placebo
Matching placebo to ertugliflozin administered orally once daily for up to 6.1 years
Placebo Comparator: Placebo
Matching placebo to ertugliflozin administered orally once daily for up to 6.1 years
Drug: Placebo
Matching placebo to ertugliflozin administered orally once daily for up to 6.1 years

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986881


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Locations
United States, Alabama
Call for Information (Investigational Site 1431)
Birmingham, Alabama, United States, 35209
United States, Arizona
Call for Information (Investigational Site 1699)
Chandler, Arizona, United States, 85224
Call for Information (Investigational Site 1634)
Gilbert, Arizona, United States, 85295
Call for Information (Investigational Site 1717)
Glendale, Arizona, United States, 85306
Call for Information (Investigational Site 1693)
Phoenix, Arizona, United States, 35032
Call for Information (Investigational Site 2189)
Tucson, Arizona, United States, 85712
Call for Information (Investigational Site 1105)
Tucson, Arizona, United States, 85724
United States, Arkansas
Call for Information (Investigational Site 1705)
Little Rock, Arkansas, United States, 72209
United States, California
Call for Information (Investigational Site 1914)
Los Angeles, California, United States, 90057
Call for Information (Investigational Site 1099)
Los Angeles, California, United States, 90073
Call for Information (Investigational Site 1441)
North Hollywood, California, United States, 91606
Call for Information (Investigational Site 1092)
Santa Ana, California, United States, 92704
Call for Information (Investigational Site 1944)
Santa Rosa, California, United States, 95405
Call for Information (Investigational Site 2161)
Thousand Oaks, California, United States, 91360
Call for Information (Investigational Site 1048)
Torrance, California, United States, 90502
Call for Information (Investigational Site 1880)
Torrance, California, United States, 90502
Call for Information (Investigational Site 1437)
Tustin, California, United States, 92780
Call for Information (Investigational Site 1939)
Ventura, California, United States, 93003
United States, Colorado
Call for Information (Investigational Site 1443)
Colorado Springs, Colorado, United States, 80909
United States, Florida
Call for Information (Investigational Site 1700)
Boynton Beach, Florida, United States, 33472
Call for Information (Investigational Site 1054)
Clearwater, Florida, United States, 33756
Call for Information (Investigational Site 1921)
Delray Beach, Florida, United States, 33446
Call for Information (Investigational Site 1104)
Hialeah, Florida, United States, 33012
Call for Information (Investigational Site 2162)
Jacksonville, Florida, United States, 32204
Call for Information (Investigational Site 2164)
Jacksonville, Florida, United States, 32216
Call for Information (Investigational Site 1724)
Lauderdale Lakes, Florida, United States, 33319
Call for Information (Investigational Site 2234)
Miami, Florida, United States, 33126
Call for Information (Investigational Site 2247)
Miami, Florida, United States, 33126
Call for Information (Investigational Site 1590)
Miami, Florida, United States, 33135
Call for Information (Investigational Site 2170)
Miami, Florida, United States, 33144
Call for Information (Investigational Site 2173)
Miami, Florida, United States, 33144
Call for Information (Investigational Site 1766)
Miami, Florida, United States, 33155
Call for Information (Investigational Site 2241)
Miami, Florida, United States, 33155
Call for Information (Investigational Site 1926)
Miami, Florida, United States, 33157
Call for Information (Investigational Site 1399)
Oakland Park, Florida, United States, 33309
Call for Information (Investigational Site 1818)
Orlando, Florida, United States, 32806
Call for Information (Investigational Site 1131)
Orlando, Florida, United States, 32825
Call for Information (Investigational Site 1094)
Ormond Beach, Florida, United States, 32174
Call for Information (Investigational Site 1084)
Palm Harbor, Florida, United States, 34684
Call for Information (Investigational Site 1060)
Plant City, Florida, United States, 33563
Call for Information (Investigational Site 1805)
Sarasota, Florida, United States, 34239-3513
Call for Information (Investigational Site 1430)
Tampa, Florida, United States, 33613
Call for Information (Investigational Site 2177)
Winter Haven, Florida, United States, 33880
United States, Georgia
Call for Information (Investigational Site 1438)
Lawrenceville, Georgia, United States, 30046
Call for Information (Investigational Site 2259)
Macon, Georgia, United States, 31210
United States, Illinois
Call for Information (Investigational Site 2174)
Chicago, Illinois, United States, 60602
United States, Indiana
Call for Information (Investigational Site 2160)
Anderson, Indiana, United States, 46011
Call for Information (Investigational Site 1097)
Avon, Indiana, United States, 46123
Call for Information (Investigational Site 1688)
Evansville, Indiana, United States, 47725
Call for Information (Investigational Site 1452)
Franklin, Indiana, United States, 46131
Call for Information (Investigational Site 2233)
Valparaiso, Indiana, United States, 46383
United States, Iowa
Call for Information (Investigational Site 1881)
Council Bluffs, Iowa, United States, 51501
United States, Kentucky
Call for Information (Investigational Site 1821)
Louisville, Kentucky, United States, 40202
Call for Information (Investigational Site 1919)
Louisville, Kentucky, United States, 40213
United States, Louisiana
Call for Information (Investigational Site 1067)
Alexandria, Louisiana, United States, 71301
Call for Information (Investigational Site 1767)
Hammond, Louisiana, United States, 70403
Call for Information (Investigational Site 1068)
Metairie, Louisiana, United States, 70006
United States, Maine
Call for Information (Investigational Site 1445)
Lewiston, Maine, United States, 04240
United States, Maryland
Call for Information (Investigational Site 2172)
Baltimore, Maryland, United States, 21229
Call for Information (Investigational Site 1790)
Baltimore, Maryland, United States, 21236
United States, Massachusetts
Call for Information (Investigational Site 1375)
Fall River, Massachusetts, United States, 02721
Call for Information (Investigational Site 1628)
Haverhill, Massachusetts, United States, 01830
Call for Information (Investigational Site 2231)
Methuen, Massachusetts, United States, 01844
United States, Michigan
Call for Information (Investigational Site 1935)
Cadillac, Michigan, United States, 49601
Call for Information (Investigational Site 1652)
Detroit, Michigan, United States, 48202
Call for Information (Investigational Site 1582)
Flint, Michigan, United States, 48504
Call for Information (Investigational Site 1704)
Saginaw, Michigan, United States, 48602-5182
United States, Missouri
Call for Information (Investigational Site 2202)
Bridgeton, Missouri, United States, 63044
Call for Information (Investigational Site 1982)
Hazelwood, Missouri, United States, 63042
United States, Montana
Call for Information (Investigational Site 1403)
Missoula, Montana, United States, 59808
United States, Nebraska
Call for Information (Investigational Site 1676)
Omaha, Nebraska, United States, 63114
United States, New Jersey
Call for Information (Investigational Site 1464)
Bridgewater, New Jersey, United States, 08807-3060
Call for Information (Investigational Site 2232)
Elizabeth, New Jersey, United States, 07201
Call for Information (Investigational Site 1891)
Neptune, New Jersey, United States, 07753
Call for Information (Investigational Site 1947)
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Call for Information (Investigational Site 1696)
Albuquerque, New Mexico, United States, 87108
United States, New York
Call for Information (Investigational Site 1129)
Bronx, New York, United States, 10455
Call for Information (Investigational Site 1091)
Brooklyn, New York, United States, 11215
Call for Information (Investigational Site 1058)
Glens Falls, New York, United States, 12801
Call for Information (Investigational Site 2235)
Hopewell Junction, New York, United States, 12533
Call for Information (Investigational Site 2236)
New Windsor, New York, United States, 12553
Call for Information (Investigational Site 1897)
New York, New York, United States, 10016
Call for Information (Investigational Site 1449)
New York, New York, United States, 10021
Call for Information (Investigational Site 1035)
Rosedale, New York, United States, 11422
United States, North Carolina
Call for Information (Investigational Site 2166)
Asheville, North Carolina, United States, 28801
Call for Information (Investigational Site 1771)
Calabash, North Carolina, United States, 28467
Call for Information (Investigational Site 1090)
Lenoir, North Carolina, United States, 28645
Call for Information (Investigational Site 1925)
Morganton, North Carolina, United States, 28655
Call for Information (Investigational Site 1871)
Raliegh, North Carolina, United States, 27609
United States, North Dakota
Call for Information (Investigational Site 1076)
Fargo, North Dakota, United States, 58103
United States, Ohio
Call for Information (Investigational Site 2180)
Cincinnati, Ohio, United States, 45236
Call for Information (Investigational Site 1080)
Columbus, Ohio, United States, 43235
Call for Information (Investigational Site 1088)
Kettering, Ohio, United States, 45429
Call for Information (Investigational Site 1039)
Marion, Ohio, United States, 43302
Call for Information (Investigational Site 1053)
Maumee, Ohio, United States, 43537
United States, Oklahoma
Call for Information (Investigational Site 1462)
Bartlesville, Oklahoma, United States, 74006
Call for Information (Investigational Site 1721)
Oklahoma City, Oklahoma, United States, 73135
United States, Pennsylvania
Call for Information (Investigational Site 2185)
Lansdale, Pennsylvania, United States, 19446
Call for Information (Investigational Site 1920)
Penndel, Pennsylvania, United States, 19047
Call for Information (Investigational Site 1066)
Philadelphia, Pennsylvania, United States, 19107
Call for Information (Investigational Site 1819)
Yardley, Pennsylvania, United States, 19067
United States, South Carolina
Call for Information (Investigational Site 2163)
Moncks Corner, South Carolina, United States, 29461
United States, Texas
Call for Information (Investigational Site 2186)
Corpus Christi, Texas, United States, 78413
Call for Information (Investigational Site 1770)
Dallas, Texas, United States, 75216
Call for Information (Investigational Site 1424)
Dallas, Texas, United States, 75390-8857
Call for Information (Investigational Site 2190)
Desoto, Texas, United States, 75115
Call for Information (Investigational Site 1636)
Fort Sam Houston, Texas, United States, 78234-4501
Call for Information (Investigational Site 1408)
Houston, Texas, United States, 77024
Call for Information (Investigational Site 1446)
Houston, Texas, United States, 77074
Call for Information (Investigational Site 1128)
Houston, Texas, United States, 77450
Call for Information (Investigational Site 1102)
Katy, Texas, United States, 77450
Call for Information (Investigational Site 2171)
Lewisville, Texas, United States, 75067-3437
Call for Information (Investigational Site 1773)
San Antonio, Texas, United States, 78228
Call for Information (Investigational Site 1694)
San Antonio, Texas, United States, 78258
Call for Information (Investigational Site 1036)
Schertz, Texas, United States, 78154
Call for Information (Investigational Site 2183)
Victoria, Texas, United States, 77901
United States, Utah
Call for Information (Investigational Site 1499)
Murray, Utah, United States, 84123
United States, Virginia
Call for Information (Investigational Site 1768)
Manassas, Virginia, United States, 20110
Call for Information (Investigational Site 1927)
Richmond, Virginia, United States, 23114
Call for Information (Investigational Site 1448)
Richmond, Virginia, United States, 23235
Call for Information (Investigational Site 1415)
Salem, Virginia, United States, 24153
Call for Information (Investigational Site 1136)
Winchester, Virginia, United States, 22601
United States, Washington
Call for Information (Investigational Site 1050)
Spokane, Washington, United States, 99207
Call for Information (Investigational Site 1044)
Walla Walla, Washington, United States, 99362
United States, Wisconsin
Call for Information (Investigational Site 1073)
Green Bay, Wisconsin, United States, 54303
Call for Information (Investigational Site 1392)
Kenosha, Wisconsin, United States, 53142
Call for Information (Investigational Site 1913)
Madison, Wisconsin, United States, 53719
Argentina
Merck Sharp & Dohme (Argentina) Inc.
Buenos Aires, Argentina
Bulgaria
Merck Sharp & Dohme Bulgaria EOOD
Sofia, Bulgaria
Colombia
MDS Colombia SAS
Bogota, Colombia
Czech Republic
MSD SRO Czech
Prague, Czech Republic, Prague 6
Georgia
Merck Sharp & Dohme IDEA, Inc.
Tbilisi, Georgia
Greece
Vianex, S.A. / MSD
Alimos, Greece
Hong Kong
Merck Sharp & Dohme (Asia) Ltd.
Hong Kong, Hong Kong
Hungary
MSD Pharma Hungary Kft.
Budapest, Hungary
Latvia
Merck Sharp & Dohme Latvija SIA
Riga, Latvia
Lithuania
UAB "Merck Sharp & Dohme"
Vilnius, Lithuania
Mexico
MSD
Mexico City, Mexico
Netherlands
Merck Sharp & Dohme BV
Haarlem, Netherlands
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd.,
Wellington, New Zealand
Poland
MSD Polska Sp. Z o.o.
Warsaw, Poland
Romania
Merck Sharp & Dohme Romania SRL
Bucharest, Romania
Serbia
Merck Sharp & Dohme
Belgrade, Serbia
Slovakia
Merck Sharp Dohme S.R.O.
Bratislava, Slovakia
South Africa
MSD (Pty) LTD South Africa
Midrand, South Africa
Thailand
MSD (Thailand) Ltd.
Bangkok, Thailand
Turkey
Merck Sharp & Dohme Ilaclari Ltd. Sti
Istanbul, Turkey
Ukraine
MSD Ukraine LLC
Kiev, Ukraine
United Kingdom
Merck Sharp & Dohme Ltd.
Hoddesdon, United Kingdom
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01986881     History of Changes
Other Study ID Numbers: 8835-004
2013-002518-11 ( EudraCT Number )
First Submitted: November 12, 2013
First Posted: November 19, 2013
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases


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