DelfaGLP-1 Atlas

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CompletedPhase 3Results posted

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

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.

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

629

Recruiting sites

—

Enrollment

14,752

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 6.5-10%

Primary endpoint

•3-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01144338
Org study IDD5551C00003
Secondary IDBCB109Bristol-Myers Squibb
Secondary IDMB001-002Bristol Myers Squibb

Timeline

Milestones

Study first posted2010-06-15estimated
Study start2010-06-18actual
Primary completion2017-04-21actual
Study completion2017-04-24actual
Last update posted2018-08-08actual
Results first posted2018-08-08actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age130 Years
SexAll
Healthy volunteersNot accepted

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.

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
7
Heart failure
1

Cardiovascular outcomes

7 endpoints
Primary/protocol endpoint

Primary Efficacy Outcome MACE Events

Time frame:Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo905—
Exenatide Once Weekly839—
Hazard Ratio (HR)0.9195% CI0.832 – 1.004p0.061Regression, Cox
Primary/protocol endpoint

Primary Safety Outcome MACE Events

Time frame:Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo905—
Exenatide Once Weekly839—
Hazard Ratio (HR)0.9195% CI0.832 – 1.004p< 0.001Regression, Cox

This analysis uses the same endpoint and cox regression method as the primary efficacy analysis. However, the statistical hypothesis is a non-inferiority test with a margin of HR=1.3.

Secondary/protocol endpoint

Secondary Efficacy Outcome All-Cause Mortality

Time frame:Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

All-cause death

time to event, event

SNOMED 419620001

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo584—
Exenatide Once Weekly507—
Hazard Ratio (HR)0.8695% CI0.77 – 0.97p0.016Regression, Cox
Secondary/protocol endpoint

Secondary Efficacy Outcome CV Death

Time frame:Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Cardiovascular death

time to event, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo383—
Exenatide Once Weekly340—
Hazard Ratio (HR)0.8895% CI0.76 – 1.02p0.096Regression, Cox
Secondary/protocol endpoint

Secondary Efficacy Outcome MI

Time frame:Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo493—
Exenatide Once Weekly483—
Hazard Ratio (HR)0.9795% CI0.85 – 1.10p0.622Regression, Cox
Secondary/protocol endpoint

Secondary Efficacy Outcome Stroke

Time frame:Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Stroke (any)

time to event, event

SNOMED 230690007

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo218—
Exenatide Once Weekly187—
Hazard Ratio (HR)0.8595% CI0.70 – 1.03p0.095Regression, Cox
Secondary/protocol endpoint/low confidence

Secondary Efficacy Outcome Hospitalization for ACS

Time frame:Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

time to event, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo570—
Exenatide Once Weekly602—
Hazard Ratio (HR)1.0595% CI0.94 – 1.18p0.402Regression, Cox

Heart failure

1 endpoint
Secondary/protocol endpoint

Secondary Efficacy Outcome Hospitalization for HF

Time frame:Time to first event. Information collected during study period (anticipated to be up to 7.5 years).

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Posted result

GroupValue (count_of_participants), Participants95% CI
Placebo231—
Exenatide Once Weekly219—
Hazard Ratio (HR)0.9495% CI0.78 – 1.13p0.485Regression, Cox

Publications (19)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.