Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Merck Sharp & Dohme Corp.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01986881
First received: November 12, 2013
Last updated: November 30, 2016
Last verified: November 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to First Occurrence of Cardiovascular Death or Hospitalization for Heart Failure [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: Yes ]
  • Time to Occurrence of Cardiovascular Death [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Time to First Occurrence of Fatal or Non-fatal Stroke [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: Yes ]
  • Time to First Occurrence of Hospitalization for Heart Failure [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Time to Occurrence of All-cause Mortality [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: Yes ]
  • Time to Occurrence of All MACE Events (not censored at the time of the first event) [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Hemoglobin A1C (HbA1C) [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: No ]
  • Time to the first Occurrence of a Participant Receiving Glycemic Rescue Therapy (Up to 18 weeks) [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
  • Time to Initiation of Insulin for Participants Not on Insulin at Randomization [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: No ]
  • Change from Baseline in Insulin Dose at the End of Study (up to 6.1 years) [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Weight [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: No ]
  • Number of Participants with a HbA1C <7% [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: No ]
  • Change from Baseline in Systolic Blood Pressure [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: No ]
  • Change from Baseline in Diastolic Blood Pressure [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: No ]
  • Number of Participants Experiencing and Adverse Event (AE) [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Treatment Due to An AE [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in HbA1C at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Weight at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
  • Number of Participants with a HbA1C <7% at Week 18 [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
  • Change from Baseline in Systolic Blood Pressure at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
  • Change from Baseline in Diastolic Blood Pressure at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
  • Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction [ Time Frame: Up to 6.1 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8000
Study Start Date: November 2013
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986881

Contacts
Contact: Toll Free Number 1-888-577-8839

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Dallas, Texas, United States, 75390-8857
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Houston, Texas, United States, 77074
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Manassas, Virginia, United States, 20110
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Kenosha, Wisconsin, United States, 53142
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Madison, Wisconsin, United States, 53719
Argentina
Merck Sharp & Dohme (Argentina) Inc. Recruiting
Buenos Aires, Argentina
Contact: Alfredo Wilkinson    54 11 4796 8200      
Bulgaria
Merck Sharp & Dohme Bulgaria EOOD Recruiting
Sofia, Bulgaria
Contact: Eran Gefen    38 (044) 393 74 80      
Colombia
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Bogota, Colombia
Contact: Francesca Carvajal    57 1219109011090      
Czech Republic
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Prague, Czech Republic, Prague 6
Contact: Thomas Johansson    420 233 010 111      
Georgia
Merck Sharp & Dohme IDEA, Inc. Recruiting
Tbilisi, Georgia
Contact: Eran Gefen    38 (044) 393 74 80      
Greece
Vianex, S.A. / MSD Recruiting
Alimos, Greece
Contact: Lazaros Poughias    30 2109897322      
Hong Kong
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Hong Kong, Hong Kong
Contact: Lai Hung Jen    886 2 2730 0030      
Mexico
MSD Recruiting
Mexico City, Mexico
Contact: Juan Marques    52 55254819608      
Netherlands
Merck Sharp & Dohme BV Recruiting
Haarlem, Netherlands
Contact: Caroline Doornebos    31 23 515 3362      
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd. Recruiting
Wellington, New Zealand
Contact: Australian Medical Information Centre    61 2 8988 8428      
Romania
Merck Sharp & Dohme Romania SRL Recruiting
Bucharest, Romania
Contact: Simona Olaru    38 (044) 393 74 80      
Slovakia
Merck Sharp Dohme S.R.O. Recruiting
Bratislava, Slovakia
Contact: Eva Kaszasova    420 233010213      
South Africa
MSD (Pty) LTD South Africa Recruiting
Midrand, South Africa
Contact: Khanyi Mzolo    27 11 655 3140      
Thailand
MSD (Thailand) Ltd. Recruiting
Bangkok, Thailand
Contact: Thanu Komolsai    66 2262 5746      
Turkey
Merck Sharp & Dohme Ilaclari Ltd. Sti Recruiting
Istanbul, Turkey
Contact: Alev Eren    90 212 336 12 63      
Ukraine
MSD Ukraine LLC Recruiting
Kiev, Ukraine
Contact: Eran Gefen    38 (044) 393 74 80      
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Mark Toms    +44 (0) 1992 452475      
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 
Study First Received: November 12, 2013
Last Updated: November 30, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 05, 2016