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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01986881




Registration number
NCT01986881
Ethics application status
Date submitted
12/11/2013
Date registered
12/11/2013
Date last updated
18/07/2018

Titles & IDs
Public title
Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)
Scientific 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
Secondary ID [1] 0 0
2013-002518-11
Secondary ID [2] 0 0
8835-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ertugliflozin
Treatment: Drugs - Placebo

Experimental: Ertugliflozin, 15 mg - Ertugliflozin 15 mg administered orally once daily for up to 6.1 years

Experimental: Ertugliflozin, 5 mg - Ertugliflozin 5 mg 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


Treatment: Drugs: Ertugliflozin
Oral, once daily, up to 6.1 years

Treatment: Drugs: Placebo
Matching placebo to ertugliflozin administered orally once daily for up to 6.1 years

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke])
Timepoint [1] 0 0
Up to 6.1 years
Secondary outcome [1] 0 0
Time to First Occurrence of Cardiovascular Death or Hospitalization for Heart Failure
Timepoint [1] 0 0
Up to 6.1 years
Secondary outcome [2] 0 0
Time to Occurrence of Cardiovascular Death
Timepoint [2] 0 0
Up to 6.1 years
Secondary outcome [3] 0 0
Time to First Occurrence of the Composite of Renal Death, Renal Dialysis/Transplant, or =2x Increase in Baseline Serum Creatinine
Timepoint [3] 0 0
Up to 6.1 years
Secondary outcome [4] 0 0
Time to First Occurrence of Mace Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina)
Timepoint [4] 0 0
Up to 6.1 years
Secondary outcome [5] 0 0
Time to First Occurrence of Fatal or Non-fatal Stroke
Timepoint [5] 0 0
Up to 6.1 years
Secondary outcome [6] 0 0
Time to First Occurrence of Hospitalization for Heart Failure
Timepoint [6] 0 0
Up to 6.1 years
Secondary outcome [7] 0 0
Time to First Occurrence of Individual Components of MACE (Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke)
Timepoint [7] 0 0
Up to 6.1 years
Secondary outcome [8] 0 0
Time to Occurrence of All-cause Mortality
Timepoint [8] 0 0
Up to 6.1 years
Secondary outcome [9] 0 0
Time to Occurrence of All MACE Events (not censored at the time of the first event)
Timepoint [9] 0 0
Up to 6.1 years
Secondary outcome [10] 0 0
Time to Occurrence of All Cardiovascular Death or Hospitalizations for Heart Failure (Not Censored at the Time of the First Event)
Timepoint [10] 0 0
Up to 6.1 years
Secondary outcome [11] 0 0
Change from Baseline in Hemoglobin A1C (HbA1C)
Timepoint [11] 0 0
Up to 6.1 years
Secondary outcome [12] 0 0
Change from Baseline in Fasting Plasma Glucose (FPG)
Timepoint [12] 0 0
Up to 6.1 years
Secondary outcome [13] 0 0
Time to the first Occurrence of a Participant Receiving Glycemic Rescue Therapy (Up to 18 weeks)
Timepoint [13] 0 0
Up to 18 weeks
Secondary outcome [14] 0 0
Time to Initiation of Insulin for Participants Not on Insulin at Randomization
Timepoint [14] 0 0
Up to 6.1 years
Secondary outcome [15] 0 0
Change from Baseline in Insulin Dose at the End of Study (up to 6.1 years)
Timepoint [15] 0 0
Up to 6.1 years
Secondary outcome [16] 0 0
Change from Baseline in Body Weight
Timepoint [16] 0 0
Up to 6.1 years
Secondary outcome [17] 0 0
Number of Participants with a HbA1C <7%
Timepoint [17] 0 0
Up to 6.1 years
Secondary outcome [18] 0 0
Change from Baseline in Systolic Blood Pressure
Timepoint [18] 0 0
Up to 6.1 years
Secondary outcome [19] 0 0
Change from Baseline in Diastolic Blood Pressure
Timepoint [19] 0 0
Up to 6.1 years
Secondary outcome [20] 0 0
Number of Participants Experiencing and Adverse Event (AE)
Timepoint [20] 0 0
Up to 6.1 years
Secondary outcome [21] 0 0
Number of Participants Discontinuing Study Treatment Due to An AE
Timepoint [21] 0 0
Up to 6.1 years
Secondary outcome [22] 0 0
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
Timepoint [22] 0 0
Up to 6.1 years
Secondary outcome [23] 0 0
Change from Baseline in HbA1C at Week 18
Timepoint [23] 0 0
Baseline and Week 18
Secondary outcome [24] 0 0
Change from Baseline in Body Weight at Week 18
Timepoint [24] 0 0
Baseline and Week 18
Secondary outcome [25] 0 0
Number of Participants with a HbA1C <7% at Week 18
Timepoint [25] 0 0
Week 18
Secondary outcome [26] 0 0
Change from Baseline in Systolic Blood Pressure at Week 18
Timepoint [26] 0 0
Baseline and Week 18
Secondary outcome [27] 0 0
Change from Baseline in Diastolic Blood Pressure at Week 18
Timepoint [27] 0 0
Baseline and Week 18
Secondary outcome [28] 0 0
Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction
Timepoint [28] 0 0
Up to 6.1 years

Eligibility
Key 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
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New Mexico
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
North Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
Wisconsin
Country [34] 0 0
Argentina
State/province [34] 0 0
Buenos Aires
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Sofia
Country [36] 0 0
Colombia
State/province [36] 0 0
Bogota
Country [37] 0 0
Czechia
State/province [37] 0 0
Prague
Country [38] 0 0
Georgia
State/province [38] 0 0
Tbilisi
Country [39] 0 0
Greece
State/province [39] 0 0
Alimos
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Hong Kong
State/province [40] 0 0
Hong Kong
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Hungary
State/province [41] 0 0
Budapest
Country [42] 0 0
Latvia
State/province [42] 0 0
Riga
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Lithuania
State/province [43] 0 0
Vilnius
Country [44] 0 0
Mexico
State/province [44] 0 0
Mexico City
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Netherlands
State/province [45] 0 0
Haarlem
Country [46] 0 0
New Zealand
State/province [46] 0 0
Wellington
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Poland
State/province [47] 0 0
Warsaw
Country [48] 0 0
Romania
State/province [48] 0 0
Bucharest
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Serbia
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Belgrade
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Slovakia
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Bratislava
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South Africa
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Midrand
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Thailand
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Bangkok
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Turkey
State/province [53] 0 0
Istanbul
Country [54] 0 0
Ukraine
State/province [54] 0 0
Kiev
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Hoddesdon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT01986881
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications