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

(Overall Cardiovascular Study):

- Diagnosis of T2DM in accordance with American Diabetes Association (ADA) guidelines

- Hemoglobin A1c (A1C) 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

(Overall Cardiovascular Study):


- Previous randomization into this trial


- 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


Key Inclusion Criteria for the 3 Glycemic Sub-studies:


1. Insulin With or Without Metformin Sub-study: Stable doses of insulin (>=20 units/day,
with variations up to 10% in the daily dose permitted) with or without metformin
(>=1500 mg/day) for at least 8 weeks prior to the time of the Screening Visit (V1) and
during the period between the Screening Visit (V1) and randomization.


2. Sulfonylurea (SU) Monotherapy Sub-study: Participants receiving a stable dose of SU
monotherapy for at least 8 weeks prior to the time of the Screening Visit (V1) and
during the period between the Screening Visit (V1) and randomization.


3. Metformin with SU Sub-study: Participants receiving a stable dose metformin (≥1500
mg/day) with a SU for at least 8 weeks prior to the time of the Screening Visit (V1)
and during the period between the Screening Visit (V1) and randomization.

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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

An overall 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 3 pre-defined glycemic sub-studies; 1. In participants receiving background insulin with or without metformin, 2. In participants receiving background sulfonylurea monotherapy, and 3. In participants receiving background metformin with sulfonylurea (all fully-enrolled).

Participants enrolled prior to Amendment 1 were in the overall study as well as a sub-study, if they met certain entry criteria. Participants enrolled following the start of Amendment 1 were only enrolled in the overall study. The sub-studies were the initial 18 weeks of the overall study period.

Detailed Description

The primary hypotheses for the 4 studies are:

  1. Overall Cardiovascular Study:

    The time to first occurrence of the composite endpoint of MACE: cardiovascular death, non-fatal myocardial infarction [MI] or non-fatal stroke in participants treated with ertugliflozin is non-inferior compared to that in participants treated with placebo.

  2. The 3 Glycemic Sub-studies:

    1. The mean reduction from baseline in hemoglobin A1c (A1C) for 15 mg ertugliflozin is greater than that for placebo.
    2. The mean reduction from baseline in A1C for 5 mg ertugliflozin is greater than that for placebo.
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, for up to approximately 6 years
    Other Name: MK-8835, PF-04971729, Steglatro
  • Drug: Placebo
    Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
  • Drug: Glycemic Rescue
    Doses of background anti-hyperglycemic agents (AHA), medications will be required to be held constant in all participants enrolled for the initial 18 weeks of the trial with 2 exceptions: First, participant will be prescribed glycemic rescue therapy if they meet specific, progressively more stringent, glycemic thresholds based on repeated, confirmed fasting plasma glucose (FPG) measured at a central laboratory. Second, a participant experiencing clinically significant hypoglycemia according to the investigator at any time during the trial is permitted to have the dose of appropriate background AHA (e.g., insulin, sulfonylurea [SU], glinide) reduced or discontinued as per the judgment of the investigator or the treating physician. Choice and dosing of glycemic rescue will be at the discretion of the investigator or the treating physician consistent with standards of care for management of patients with Type 2 diabetes mellitus (T2DM) within the country of the investigational site.
Study Arms  ICMJE
  • Experimental: Ertugliflozin, 15 mg
    Ertugliflozin 15 mg administered orally once daily for up to approximately 6 years
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Glycemic Rescue
  • Experimental: Ertugliflozin, 5 mg
    Ertugliflozin 5 mg administered orally once daily for up to approximately 6 years
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo
    • Drug: Glycemic Rescue
  • Placebo Comparator: Placebo
    Matching placebo to ertugliflozin administered orally once daily for up to approximately 6 years
    Interventions:
    • Drug: Placebo
    • Drug: Glycemic Rescue
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 (Overall Cardiovascular Study):

  • Diagnosis of T2DM in accordance with American Diabetes Association (ADA) guidelines
  • Hemoglobin A1c (A1C) 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 (Overall Cardiovascular Study):

  • Previous randomization into this trial
  • 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

Key Inclusion Criteria for the 3 Glycemic Sub-studies:

  1. Insulin With or Without Metformin Sub-study: Stable doses of insulin (>=20 units/day, with variations up to 10% in the daily dose permitted) with or without metformin (>=1500 mg/day) for at least 8 weeks prior to the time of the Screening Visit (V1) and during the period between the Screening Visit (V1) and randomization.
  2. Sulfonylurea (SU) Monotherapy Sub-study: Participants receiving a stable dose of SU monotherapy for at least 8 weeks prior to the time of the Screening Visit (V1) and during the period between the Screening Visit (V1) and randomization.
  3. Metformin with SU Sub-study: Participants receiving a stable dose metformin (?1500 mg/day) with a SU for at least 8 weeks prior to the time of the Screening Visit (V1) and during the period between the Screening Visit (V1) and randomization.
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 )
B1521021 ( Other Identifier: Pfizer Protocol 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 January 2021

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