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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04255433




Registration number
NCT04255433
Ethics application status
Date submitted
3/02/2020
Date registered
5/02/2020
Date last updated
18/11/2020

Titles & IDs
Public title
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
Scientific title
The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)
Secondary ID [1] 0 0
I8F-MC-GPGN
Secondary ID [2] 0 0
17073
Universal Trial Number (UTN)
Trial acronym
SURPASS-CVOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tirzepatide
Treatment: Drugs - Dulaglutide

Experimental: Tirzepatide - Tirzepatide administered subcutaneously (SC) once a week.

Active Comparator: Dulaglutide - Dulaglutide administered SC once a week.


Treatment: Drugs: Tirzepatide
Administered SC

Treatment: Drugs: Dulaglutide
Administered SC

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3) - Time to First Occurrence of a component event of MACE-3
Timepoint [1] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [1] 0 0
Time to Death from Any Cause - Time to Death from Any Cause
Timepoint [1] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [2] 0 0
Time to CV Death - Time to CV Death
Timepoint [2] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [3] 0 0
Time to First Occurrence of MI - Time to First Occurrence of MI
Timepoint [3] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [4] 0 0
Time to First Occurrence of Stroke - Time to First Occurrence of Stroke
Timepoint [4] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [5] 0 0
Percentage of Participants with More than 10% Weight Loss - Percentage of Participants with More than 10% Weight Loss
Timepoint [5] 0 0
36 Months
Secondary outcome [6] 0 0
Change from Baseline in Body Weight - Change from Baseline in Body Weight
Timepoint [6] 0 0
Baseline, End of Study (Approximate Maximum 54 Months)
Secondary outcome [7] 0 0
Change from Baseline in Hemoglobin A1c (HbA1c) - Change from Baseline in HbA1c
Timepoint [7] 0 0
Baseline, End of Study (Approximate Maximum 54 Months)
Secondary outcome [8] 0 0
Change from Baseline in Urinary Albumin to Creatinine Ratio - Change from Baseline in Urinary Albumin to Creatinine Ratio
Timepoint [8] 0 0
Baseline, End of Study (Approximate Maximum 54 Months)
Secondary outcome [9] 0 0
Change from Baseline in Blood Lipids - Change from Baseline in Blood Lipids (Total Cholesterol, Low-Density Lipoprotein Cholesterol, High-Density Lipoprotein Cholesterol, and Triglycerides)
Timepoint [9] 0 0
Baseline, End of Study (Approximate Maximum 54 Months)
Secondary outcome [10] 0 0
Time to First Occurrence of Revascularization - Time to First Occurrence of Revascularization
Timepoint [10] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [11] 0 0
Time to First Occurrence of Hospitalization Due to Unstable Angina - Time to First Occurrence of Hospitalization Due to Unstable Angina
Timepoint [11] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [12] 0 0
Time to First Occurrence of New or Worsening Nephropathy - Time to First Occurrence of New or Worsening Nephropathy
Timepoint [12] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [13] 0 0
Time to CV Death, MI, Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina - Time to CV Death, MI, Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina
Timepoint [13] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [14] 0 0
Cumulative Number of Primary Composite Events of CV Death and Total (First and Recurrent) MI and/or Stroke - Cumulative Number of Primary Composite Events of CV Death and Total (First and Recurrent) MI and/or Stroke
Timepoint [14] 0 0
End of Study (Approximate Maximum 54 Months)
Secondary outcome [15] 0 0
Cumulative Number of CV Deaths and Total (First and Recurrent) Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure Visits - Cumulative Number of CV Deaths and Total (First and Recurrent) Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure Visits
Timepoint [15] 0 0
End of Study (Approximate Maximum 54 Months)

Eligibility
Key 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)
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders - Camperdown
Recruitment hospital [2] 0 0
Nepean Family Metabolic Health Service - Kingswood
Recruitment hospital [3] 0 0
The AIM Centre / Hunter Diabetes Centre - Merewether
Recruitment hospital [4] 0 0
Illawarra Shoalhaven Local Health District - Wollongong
Recruitment hospital [5] 0 0
Core Research Group - Brisbane
Recruitment hospital [6] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [7] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [8] 0 0
Mater Adult Hospital Brisbane - South Brisbane
Recruitment hospital [9] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [10] 0 0
Heart and Vascular Institute - Adelaide
Recruitment hospital [11] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [12] 0 0
Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
Recruitment hospital [13] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [14] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [15] 0 0
Monash Cardiovascular Research Centre - Clayton
Recruitment hospital [16] 0 0
Barwon Health - The Geelong Hospital - Geelong
Recruitment hospital [17] 0 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg Heights
Recruitment hospital [18] 0 0
School of Medicine, Fremantle Hospital - Fremantle
Recruitment hospital [19] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [20] 0 0
GenesisCare - Wexford Medical Centre WA - Murdoch
Recruitment hospital [21] 0 0
GenesisCare - Shenton House - Joondalup
Recruitment postcode(s) [1] 0 0
2006 - Camperdown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
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2291 - Merewether
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2500 - Wollongong
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4064 - Brisbane
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4814 - Douglas
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4029 - Herston
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4700 - South Brisbane
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4215 - Southport
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5000 - Adelaide
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5046 - Oaklands Park
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7250 - Launceston
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3128 - Box Hill
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3168 - Clayton
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3220 - Geelong
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3081 - Heidelberg Heights
Recruitment postcode(s) [17] 0 0
6160 - Fremantle
Recruitment postcode(s) [18] 0 0
6150 - Murdoch
Recruitment postcode(s) [19] 0 0
6027 - Joondalup
Recruitment outside Australia
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Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04255433
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
Clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04255433