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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 : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Tirzepatide Drug: Dulaglutide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : October 17, 2024
Estimated Study Completion Date : October 17, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC) once a week.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Active Comparator: Dulaglutide
Dulaglutide administered SC once a week.
 Drug: Dulaglutide
Administered SC
Other Name: LY2189265


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time to Death from Any Cause [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to Death from Any Cause

  2. Time to CV Death [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to CV Death

  3. Time to First Occurrence of MI [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to First Occurrence of MI

  4. Time to First Occurrence of Stroke [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to First Occurrence of Stroke

  5. Percentage of Participants with More than 10% Weight Loss [ Time Frame: 36 Months ]
    Percentage of Participants with More than 10% Weight Loss

  6. Change from Baseline in Body Weight [ Time Frame: Baseline, End of Study (Approximate Maximum 54 Months) ]
    Change from Baseline in Body Weight

  7. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, End of Study (Approximate Maximum 54 Months) ]
    Change from Baseline in HbA1c

  8. 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

  9. 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)

  10. Time to First Occurrence of Revascularization [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]
    Time to First Occurrence of Revascularization

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04255433


Contacts
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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

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04255433    
Other Study ID Numbers: 17073
I8F-MC-GPGN ( Other Identifier: Eli Lilly and Company )
2019-002735-28 ( EudraCT Number )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 1, 2020
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
 Tirzepatide
Incretins
Glucagon-Like Peptide 1
Gastric Inhibitory Polypeptide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs