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

NCT01986881

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
Brief Title  ICMJE Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Ertugliflozin, 15 mg
    Ertugliflozin 15 mg administered orally once daily for up to 6.1 years
    Intervention: Drug: Ertugliflozin
  • Experimental: Ertugliflozin, 5 mg
    Ertugliflozin 5 mg administered orally once daily for up to 6.1 years
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Matching placebo to ertugliflozin administered orally once daily for up to 6.1 years
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2020)
8246
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2013)
3900
Actual Study Completion Date  ICMJE December 27, 2019
Actual Primary Completion Date December 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina,   Australia,   Bulgaria,   Canada,   Colombia,   Croatia,   Czech Republic,   Czechia,   Georgia,   Greece,   Hong Kong,   Hungary,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Philippines,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT01986881
Other Study ID Numbers  ICMJE 8835-004
2013-002518-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL:http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Medical DirectorMerck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP