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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)

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ClinicalTrials.gov Identifier: NCT01986881
Recruitment Status : Active, not recruiting
First Posted : November 19, 2013
Last Update Posted : April 15, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 12, 2013
First Posted Date  ICMJE November 19, 2013
Last Update Posted Date April 15, 2019
Actual Study Start Date  ICMJE November 4, 2013
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
Time to First Occurrence of Any Component of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke [ Time Frame: Up to 6.3 years ]
Change History Complete list of historical versions of study NCT01986881 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
  • Time to First Occurrence of any of the Components of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina [ Time Frame: Up to 6.3 years ]
  • Number of Participants Experiencing An Adverse Event (AE) [ Time Frame: Up to 6.3 years ]
  • Number of Participants Discontinuing Study Treatment Due to An AE [ Time Frame: Up to 6.3 years ]
  • Change from Baseline In Hemoglobin A1c (HbA1c) at Week 18 [ Time Frame: Baseline and Week 18 ]
  • Change from Baseline In HbA1c at the End of Study (up to 6.3 years) [ Time Frame: Baseline and at the End of Study (up to 6.3 years) ]
  • Change from Baseline in Fasting Plasma Glucose (FPG) at Week 18 [ Time Frame: Baseline and Week 18 ]
  • Change from Baseline in Body Weight at Week 18 [ Time Frame: Baseline and Week 18 ]
  • Change from Baseline in Body Weight at the End of Study (up to 6.3 years) [ Time Frame: Baseline and at the End of Study (up to 6.3 years) ]
  • Number of Participants with a HbA1C <7% at Week 18 [ Time Frame: Week 18 ]
  • Number of Participants with a HbA1c <7% at the End of Study (up to 6.3 years) [ Time Frame: At the End of Study (up to 6.3 years) ]
  • Change from Baseline in Systolic Blood Pressure at Week 18 [ Time Frame: Baseline and Week 18 ]
  • Change from Baseline in Systolic Blood Pressure at the End of Study (up to 6.3 years) [ Time Frame: Baseline and at the End of Study (up to 6.3 years) ]
  • Change from Baseline in Diastolic Blood Pressure at Week 18 [ Time Frame: Baseline and Week 18 ]
  • Change from Baseline in Diastolic Blood Pressure at the End of Study (up to 6.3 years) [ Time Frame: Baseline and at the End of Study (up to 6.3 years) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2016)
8000
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2013)
3900
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date December 30, 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 Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date April 2019

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