Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 August 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: August 11, 2016
Last verified: August 2016
  Purpose
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).

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Ertugliflozin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 8000
Study Start Date: November 2013
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ertugliflozin, 15 mg
Ertugliflozin 15 mg administered orally once daily for up to 6.1 years
Drug: Ertugliflozin
Oral, once daily, up to 6.1 years
Other Name: MK-8835
Experimental: Ertugliflozin, 5 mg
Ertugliflozin 5 mg administered orally once daily for up to 6.1 years
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
Placebo Comparator: Placebo
Matching placebo to ertugliflozin administered orally once daily for up to 6.1 years
Drug: Placebo
Matching placebo to ertugliflozin administered orally once daily for up to 6.1 years

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986881

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, Florida
Call for Information (Investigational Site 1700) Recruiting
Boynton Beach, Florida, United States, 33472
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01986881     History of Changes
Other Study ID Numbers: 8835-004  2013-002518-11 
Study First Received: November 12, 2013
Last Updated: August 11, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2016