Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004) - Full Text View

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 Intervention Model: Parallel Assignment Masking: Participant, 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:

MedlinePlus related topics: Vascular Diseases

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	8000
Actual Study Start Date:	November 4, 2013
Estimated Study Completion Date:	October 31, 2019
Estimated Primary Completion Date:	October 31, 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)
Sexes Eligible for Study:	All
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

Show 149 Study Locations

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 ( EudraCT Number )
Study First Received:	November 12, 2013
Last Updated:	April 6, 2017

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 July 07, 2017