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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)

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

November 12, 2013
November 30, 2016
November 2013
October 2019   (final data collection date for primary outcome measure)
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 ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01986881 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Number of Participants Experiencing An Adverse Event (AE) [ Time Frame: Up to 6.3 years ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Treatment Due to An AE [ Time Frame: Up to 6.3 years ] [ Designated as safety issue: Yes ]
  • Change from Baseline In Hemoglobin A1c (HbA1c) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Plasma Glucose (FPG) 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 ]
  • 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) ] [ Designated as safety issue: No ]
  • Number of Participants with a HbA1C <7% at Week 18 [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
  • 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) ] [ 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 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) ] [ 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 ]
  • 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) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8000
October 2019
October 2019   (final data collection date for primary outcome measure)

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
Both
40 Years and older   (Adult, Senior)
No
Contact: Toll Free Number 1-888-577-8839
United States,   Argentina,   Bulgaria,   Colombia,   Czech Republic,   Georgia,   Greece,   Hong Kong,   Mexico,   Netherlands,   New Zealand,   Romania,   Slovakia,   South Africa,   Thailand,   Turkey,   Ukraine,   United Kingdom
Australia,   Canada,   Croatia,   Israel,   Italy,   Korea, Republic of,   Philippines,   Poland,   Russian Federation,   Sweden,   Taiwan
 
NCT01986881
8835-004, 2013-002518-11
Yes
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Pfizer
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2016

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