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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04255433
Ethics application status
Date submitted
3/02/2020
Date registered
5/02/2020

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)
Timepoint [1] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [1] 0 0
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
Timepoint [2] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [3] 0 0
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
Timepoint [4] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [5] 0 0
Time to First Occurrence of the Expanded Composite of CV Death, MI, Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina
Timepoint [5] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [6] 0 0
Cumulative Number of CV Deaths and Total (First and Recurrent) Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure Visits
Timepoint [6] 0 0
End of Study (Approximate Maximum 54 Months)
Secondary outcome [7] 0 0
Percentage of Participants with More than 10% Weight Loss
Timepoint [7] 0 0
36 Months
Secondary outcome [8] 0 0
Change from Baseline in Body Weight
Timepoint [8] 0 0
Baseline, End of Study (Approximate Maximum 54 Months)
Secondary outcome [9] 0 0
Change from Baseline in Hemoglobin A1c (HbA1c)
Timepoint [9] 0 0
Baseline, End of Study (Approximate Maximum 54 Months)
Secondary outcome [10] 0 0
Change from Baseline in Urinary Albumin to Creatinine Ratio
Timepoint [10] 0 0
Baseline, End of Study (Approximate Maximum 54 Months)
Secondary outcome [11] 0 0
Change from Baseline in Blood Lipids
Timepoint [11] 0 0
Baseline, End of Study (Approximate Maximum 54 Months)
Secondary outcome [12] 0 0
Time to First Occurrence of Revascularization
Timepoint [12] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [13] 0 0
Time to First Occurrence of Hospitalization Due to Unstable Angina
Timepoint [13] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [14] 0 0
Time to First Occurrence of New or Worsening Nephropathy
Timepoint [14] 0 0
Randomization up to Study Completion (Approximate Maximum 54 Months)
Secondary outcome [15] 0 0
Cumulative Number of Primary Composite Events of CV Death and Total (First and Recurrent) MI and/or Stroke
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
Sex
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
* Are currently planning treatment for diabetic retinopathy and/or macular edema
* 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 currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
* 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)
* Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
Accrual to date
Final
13299
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The AIM Centre / Hunter Diabetes Centre - Merewether
Recruitment hospital [2] 0 0
Nepean Hospital - Penrith
Recruitment hospital [3] 0 0
University of Sydney - Charles Perkins Centre - Sydney
Recruitment hospital [4] 0 0
Illawarra Shoalhaven Local Health District - Wollongong
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [6] 0 0
Core Research Group - Brisbane
Recruitment hospital [7] 0 0
Mater Misericordiae Limited - Brisbane
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Gold Coast University Hospital - Southport
Recruitment hospital [9] 0 0
The Townsville Hospital - Townsville
Recruitment hospital [10] 0 0
Nightingale Research - Adelaide
Recruitment hospital [11] 0 0
Royal Adelaide Hospital - Adelaide
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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
Victorian Heart Hospital - Clayton
Recruitment hospital [16] 0 0
Barwon Health - Geelong
Recruitment hospital [17] 0 0
Austin Health - Repatriation Hospital - Heidelberg West
Recruitment hospital [18] 0 0
School of Medicine, Fremantle Hospital - Fremantle
Recruitment hospital [19] 0 0
Advara HeartCare Joondalup - Joondalup
Recruitment hospital [20] 0 0
GenesisCare - Murdoch - Murdoch Drive - Murdoch
Recruitment postcode(s) [1] 0 0
2291 - Merewether
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2747 - Penrith
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2006 - Sydney
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2500 - Wollongong
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4029 - Brisbane
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4064 - Brisbane
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4101 - Brisbane
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4215 - Southport
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4814 - Townsville
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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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3084 - Heidelberg West
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6160 - Fremantle
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6027 - Joondalup
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6150 - Murdoch
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Country [186] 0 0
Netherlands
State/province [186] 0 0
Zuid-Holland
Country [187] 0 0
Netherlands
State/province [187] 0 0
Utrecht
Country [188] 0 0
Poland
State/province [188] 0 0
Dolnoslaskie
Country [189] 0 0
Poland
State/province [189] 0 0
Lubelskie
Country [190] 0 0
Poland
State/province [190] 0 0
Mazowieckie
Country [191] 0 0
Poland
State/province [191] 0 0
Malopolskie
Country [192] 0 0
Poland
State/province [192] 0 0
Podlaskie
Country [193] 0 0
Poland
State/province [193] 0 0
Pomorskie
Country [194] 0 0
Poland
State/province [194] 0 0
Wielkopolskie
Country [195] 0 0
Poland
State/province [195] 0 0
Lódzkie
Country [196] 0 0
Poland
State/province [196] 0 0
Slaskie
Country [197] 0 0
Puerto Rico
State/province [197] 0 0
Bayamon
Country [198] 0 0
Puerto Rico
State/province [198] 0 0
Manati
Country [199] 0 0
Puerto Rico
State/province [199] 0 0
Ponce
Country [200] 0 0
Puerto Rico
State/province [200] 0 0
San Juan
Country [201] 0 0
Romania
State/province [201] 0 0
Alba
Country [202] 0 0
Romania
State/province [202] 0 0
Bihor
Country [203] 0 0
Romania
State/province [203] 0 0
Bra?ov
Country [204] 0 0
Romania
State/province [204] 0 0
Bucure?ti
Country [205] 0 0
Romania
State/province [205] 0 0
Constan?a
Country [206] 0 0
Romania
State/province [206] 0 0
Dolj
Country [207] 0 0
Romania
State/province [207] 0 0
Maramure?
Country [208] 0 0
Romania
State/province [208] 0 0
Mure?
Country [209] 0 0
Romania
State/province [209] 0 0
Prahova
Country [210] 0 0
Romania
State/province [210] 0 0
Timi?
Country [211] 0 0
Romania
State/province [211] 0 0
Bacau
Country [212] 0 0
Romania
State/province [212] 0 0
Gala?i
Country [213] 0 0
Romania
State/province [213] 0 0
Ia?i
Country [214] 0 0
Russian Federation
State/province [214] 0 0
Arkhangel'skaya Oblast'
Country [215] 0 0
Russian Federation
State/province [215] 0 0
Komi, Respublika
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Russian Federation
State/province [216] 0 0
Leningradskaya Oblast'
Country [217] 0 0
Russian Federation
State/province [217] 0 0
Moskva
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Russian Federation
State/province [218] 0 0
Novosibirskaya Oblast'
Country [219] 0 0
Russian Federation
State/province [219] 0 0
Rostovskaya Oblast'
Country [220] 0 0
Russian Federation
State/province [220] 0 0
Ryazanskaya Oblast'
Country [221] 0 0
Russian Federation
State/province [221] 0 0
Sankt-Peterburg
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Russian Federation
State/province [222] 0 0
Saratovskaya Oblast'
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Russian Federation
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Tomskaya Oblast'
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Russian Federation
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Slovakia
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Slovakia
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Slovakia
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Spain
State/province [232] 0 0
Almería
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Spain
State/province [233] 0 0
Andalucía
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Spain
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Spain
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Castilla Y León
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Spain
State/province [236] 0 0
Cádiz
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Spain
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Spain
State/province [238] 0 0
Madrid
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Spain
State/province [239] 0 0
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Spain
State/province [240] 0 0
València
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Spain
State/province [241] 0 0
Granada
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Spain
State/province [242] 0 0
Sevilla
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Sweden
State/province [243] 0 0
Dalarnas Län [se-20]
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Sweden
State/province [244] 0 0
Jämtlands Län [se-23]
Country [245] 0 0
Sweden
State/province [245] 0 0
Skåne Län [se-12]
Country [246] 0 0
Sweden
State/province [246] 0 0
Stockholms Län [se-01]
Country [247] 0 0
Sweden
State/province [247] 0 0
Västra Götalands Län [se-14]
Country [248] 0 0
Sweden
State/province [248] 0 0
Örebro Län [se-18]
Country [249] 0 0
Taiwan
State/province [249] 0 0
Changhua
Country [250] 0 0
Taiwan
State/province [250] 0 0
Hsinchu
Country [251] 0 0
Taiwan
State/province [251] 0 0
Hualien
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Taiwan
State/province [252] 0 0
Kaohsiung
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Taiwan
State/province [253] 0 0
Tainan
Country [254] 0 0
Taiwan
State/province [254] 0 0
Taichung
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Taiwan
State/province [255] 0 0
Taipei
Country [256] 0 0
Taiwan
State/province [256] 0 0
Taoyuan
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Turkey
State/province [257] 0 0
Adana
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Turkey
State/province [258] 0 0
Diyarbakir
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Turkey
State/province [259] 0 0
Eskisehir
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Turkey
State/province [260] 0 0
Izmir
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Turkey
State/province [261] 0 0
Mersin
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Turkey
State/province [262] 0 0
Ankara
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Turkey
State/province [263] 0 0
Antalya
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Turkey
State/province [264] 0 0
Aydin
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Turkey
State/province [265] 0 0
Denizli
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Turkey
State/province [266] 0 0
Erzurum
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Turkey
State/province [267] 0 0
Gaziantep
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Turkey
State/province [268] 0 0
Istanbul
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Turkey
State/province [269] 0 0
Kayseri
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Turkey
State/province [270] 0 0
Kocaeli
Country [271] 0 0
Turkey
State/province [271] 0 0
Malatya
Country [272] 0 0
Ukraine
State/province [272] 0 0
Chernivetska Oblast
Country [273] 0 0
Ukraine
State/province [273] 0 0
Dnipropetrovska Oblast
Country [274] 0 0
Ukraine
State/province [274] 0 0
Kharkivska Oblast
Country [275] 0 0
Ukraine
State/province [275] 0 0
Kyivska Oblast
Country [276] 0 0
Ukraine
State/province [276] 0 0
Kyiv
Country [277] 0 0
Ukraine
State/province [277] 0 0
Lvivska Oblast
Country [278] 0 0
Ukraine
State/province [278] 0 0
Odeska Oblast
Country [279] 0 0
Ukraine
State/province [279] 0 0
Poltavska Oblast
Country [280] 0 0
Ukraine
State/province [280] 0 0
Sumska Oblast
Country [281] 0 0
Ukraine
State/province [281] 0 0
Vinnytska Oblast
Country [282] 0 0
Ukraine
State/province [282] 0 0
Zaporizka Oblast
Country [283] 0 0
United Kingdom
State/province [283] 0 0
Aberdeen City
Country [284] 0 0
United Kingdom
State/province [284] 0 0
Angus
Country [285] 0 0
United Kingdom
State/province [285] 0 0
Bristol, City Of
Country [286] 0 0
United Kingdom
State/province [286] 0 0
Cambridgeshire
Country [287] 0 0
United Kingdom
State/province [287] 0 0
Devon
Country [288] 0 0
United Kingdom
State/province [288] 0 0
England
Country [289] 0 0
United Kingdom
State/province [289] 0 0
Glasgow City
Country [290] 0 0
United Kingdom
State/province [290] 0 0
Kingston Upon Hull
Country [291] 0 0
United Kingdom
State/province [291] 0 0
Leicestershire
Country [292] 0 0
United Kingdom
State/province [292] 0 0
Suffolk
Country [293] 0 0
United Kingdom
State/province [293] 0 0
Swansea [Abertawe Gb-ata]
Country [294] 0 0
United Kingdom
State/province [294] 0 0
Liverpool

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04255433