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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01144338




Registration number
NCT01144338
Ethics application status
Date submitted
10/06/2010
Date registered
15/06/2010
Date last updated
8/08/2018

Titles & IDs
Public title
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus
Scientific title
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus.
Secondary ID [1] 0 0
MB001-002
Secondary ID [2] 0 0
D5551C00003
Universal Trial Number (UTN)
Trial acronym
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 - Exenatide Once Weekly
Treatment: Drugs - Placebo

Experimental: Exenatide Once Weekly -

Placebo Comparator: Placebo -


Treatment: Drugs: Exenatide Once Weekly
Subcutaneous injection, 2 mg, administered once weekly.

Treatment: Drugs: Placebo
Subcutaneous injection, matching volume of placebo, administered once weekly.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy Outcome MACE Events
Timepoint [1] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Primary outcome [2] 0 0
Primary Safety Outcome MACE Events
Timepoint [2] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [1] 0 0
Secondary Efficacy Outcome All-Cause Mortality
Timepoint [1] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [2] 0 0
Secondary Efficacy Outcome CV Death
Timepoint [2] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [3] 0 0
Secondary Efficacy Outcome MI
Timepoint [3] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [4] 0 0
Secondary Efficacy Outcome Stroke
Timepoint [4] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [5] 0 0
Secondary Efficacy Outcome Hospitalization for ACS
Timepoint [5] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary outcome [6] 0 0
Secondary Efficacy Outcome Hospitalization for HF
Timepoint [6] 0 0
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Eligibility
Key inclusion criteria
- Patient has type 2 diabetes mellitus

- Patient has an HbA1c of = 6.5 % and = 10.0% and is currently using one of the
following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B)
Insulin therapy, either alone or in combination with up to two oral agents

- Female patients must not be breast feeding and agree to use an effective method of
contraception or must not otherwise be at risk of becoming pregnant.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.

- Patient has ever been treated with an approved or investigational GLP-1 receptor
agonist.

- Patient is enrolled in another experimental protocol which involves the use of an
investigational drug or device, or an intervention that would interfere with the
conduct of the trial.

- Patient has a planned or anticipated revascularization procedure.

- Pregnancy or planned pregnancy during the trial period.

- Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR)
of <30 mL/min/1.73m2.

- Patient has a history of gastroparesis or pancreatitis.

- Personal or family history of medullary thyroid cancer or MEN2 (Multiple
EndocrineNeoplasia Type 2) or calcitonin level of >40 ng/L at baseline.

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 assessing the outcomes
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2017
Sample size
Target
Accrual to date
Final
14752
Recruitment in Australia
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Research Site - Camperdown
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Research Site - Sydney
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5000 - Adelaide
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2050 - Camperdown
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3168 - Clayton
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2250 - East Gosford
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5112 - Elizabeth Vale
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3065 - Fitzroy
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2605 - Garran
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3220 - Geelong
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3081 - Heidelberg West
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4131 - Meadobank
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4064 - Milton
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3050 - Parkville
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2006 - Sydney
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West Sussex

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will compare the impact of including exenatide once weekly in addition to usual
care vs. usual care without exenatide on major cardiovascular outcomes as measured by the
primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction
(MI), or nonfatal stroke.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01144338
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephanie Gustavson, PhD
Address 0 0
AstraZeneca
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