Cardiovascular Outcomes Following Treatment With Ertugliflozin in Participants With Type 2 Diabetes Mellitus and Established Vascular Disease (MK-8835-004)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 9, 2014
Last verified: September 2014

November 12, 2013
September 9, 2014
November 2013
June 2020   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01986881 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cardiovascular Outcomes Following Treatment With Ertugliflozin in Participants With Type 2 Diabetes Mellitus and Established Vascular Disease (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

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 and another pre-defined glycemic sub-study in participants receiving background sulfonylurea monotherapy.

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 6.3 years
    Other Name: MK-8835
  • Drug: Placebo
    Matching placebo to ertugliflozin administered orally once daily for up to 6.3 years
  • Experimental: Ertugliflozin, 15 mg
    Ertugliflozin 15 mg administered orally once daily for up to 6.3 years
    Intervention: Drug: Ertugliflozin
  • Experimental: Ertugliflozin, 5 mg
    Ertugliflozin 5 mg administered orally once daily for up to 6.3 years
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Matching placebo to ertugliflozin administered orally once daily for up to 6.3 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
3900
June 2020
June 2020   (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
  • 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
  • Additional Inclusion Criteria Specific to the Insulin +/- Metformin Add-on Glycemic Sub-Study
  • Insulin >=20 units/day with or without metformin >=1,500 mg/day stable doses for at least 8 weeks prior to study participation
  • Additional Inclusion Criteria Specific to the sulfonylurea (SU) Monotherapy Add-on Glycemic Sub-Study
  • Monotherapy with an acceptable dose of a SU. The dose of the SU monotherapy must have been stable for at least 8 weeks prior to study participation.

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) Class III or IV heart failure at study participation
  • History of type 1 diabetes mellitus or a history of ketoacidosis
  • Additional Exclusion Criteria Specific to the Insulin +/- Metformin Add-on Glycemic Sub-Study
  • Use of prandial insulin alone without basal insulin
Both
40 Years and older
No
Contact: Toll Free Number 1-888-577-8839
United States,   Australia,   Bulgaria,   Canada,   Croatia,   Georgia,   Hong Kong,   Israel,   Korea, Republic of,   Netherlands,   New Zealand,   Philippines,   Poland,   Russian Federation,   South Africa,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom
 
NCT01986881
8835-004, 2013-002518-11
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Pfizer
Not Provided
Merck Sharp & Dohme Corp.
September 2014

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