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A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes (SURPASS-CVOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04255433
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE February 3, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date September 17, 2020
Actual Study Start Date  ICMJE May 29, 2020
Estimated Primary Completion Date October 17, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2020)
Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3) [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
Time to First Occurrence of a component event of MACE-3
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2020)
  • Time to Death from Any Cause [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to Death from Any Cause
  • Time to CV Death [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to CV Death
  • Time to First Occurrence of MI [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to First Occurrence of MI
  • Time to First Occurrence of Stroke [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to First Occurrence of Stroke
  • Percentage of Participants with More than 10% Weight Loss [ Time Frame: 36 Months ]
    Percentage of Participants with More than 10% Weight Loss
  • Change from Baseline in Body Weight [ Time Frame: Baseline, End of Study (Approximate Maximum 54 Months) ]
    Change from Baseline in Body Weight
  • Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, End of Study (Approximate Maximum 54 Months) ]
    Change from Baseline in HbA1c
  • Change from Baseline in Urinary Albumin to Creatinine Ratio [ Time Frame: Baseline, End of Study (Approximate Maximum 54 Months) ]
    Change from Baseline in Urinary Albumin to Creatinine Ratio
  • Change from Baseline in Blood Lipids [ Time Frame: Baseline, End of Study (Approximate Maximum 54 Months) ]
    Change from Baseline in Blood Lipids (Total Cholesterol, Low-Density Lipoprotein Cholesterol, High-Density Lipoprotein Cholesterol, and Triglycerides)
  • Time to First Occurrence of Revascularization [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to First Occurrence of Revascularization
  • Time to First Occurrence of Hospitalization Due to Unstable Angina [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to First Occurrence of Hospitalization Due to Unstable Angina
  • Time to First Occurrence of New or Worsening Nephropathy [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to First Occurrence of New or Worsening Nephropathy
  • Time to CV Death, MI, Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to CV Death, MI, Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina
  • Cumulative Number of Primary Composite Events of CV Death and Total (First and Recurrent) MI and/or Stroke [ Time Frame: End of Study (Approximate Maximum 54 Months) ]
    Cumulative Number of Primary Composite Events of CV Death and Total (First and Recurrent) MI and/or Stroke
  • Cumulative Number of CV Deaths and Total (First and Recurrent) Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure Visits [ Time Frame: End of Study (Approximate Maximum 54 Months) ]
    Cumulative Number of CV Deaths and Total (First and Recurrent) Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure Visits
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
Official Title  ICMJE The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)
Brief Summary The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
Detailed Description Not Provided
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: Tirzepatide
    Administered SC
    Other Name: LY3298176
  • Drug: Dulaglutide
    Administered SC
    Other Name: LY2189265
Study Arms  ICMJE
  • Experimental: Tirzepatide
    Tirzepatide administered subcutaneously (SC) once a week.
    Intervention: Drug: Tirzepatide
  • Active Comparator: Dulaglutide
    Dulaglutide administered SC once a week.
    Intervention: Drug: Dulaglutide
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2020)
12500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 17, 2024
Estimated Primary Completion Date October 17, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis of type 2 diabetes
  • Have confirmed atherosclerotic cardiovascular disease
  • HbA1c ≥7.0% to ≤10.5%
  • Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)

Exclusion Criteria:

  • Have had a major cardiovascular event within the last 60 days
  • Have type 1 diabetes mellitus
  • Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
  • Have a history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment
  • Currently planning a coronary, carotid, or peripheral artery revascularization
  • Have a history of pancreatitis
  • Have a history of ketoacidosis or hyperosmolar state/coma
  • Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect gastrointestinal (GI) motility
  • Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
  • Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
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: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czechia,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04255433
Other Study ID Numbers  ICMJE 17073
I8F-MC-GPGN ( Other Identifier: Eli Lilly and Company )
2019-002735-28 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date September 2020

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