HARRP

Completed

Harmonizing RCT-Duplicate Emulations In A Real World Replication Program (HARRP)

Harmonizing RCT-Duplicate Emulations: A Real World Replication Program Analyzing Three Clinical Trials, CANVAS, LEADER, and SAVOR TIMI in Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

239,990

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

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

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 IDNCT06099067

Org study IDD1843R00345

Timeline

Milestones

Study start2020-05-15actual

Primary completion2023-08-31actual

Study completion2023-08-31actual

Study first posted2023-10-25actual

Last update posted2024-08-30actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Type 2 diabetes mellitus (T2DM) adult patients enrolled in the two claims databases and are eligible to be included according to the inclusion and exclusion criteria of each of the three investigated clinical trial studies: CANVAS, LEADER and SAVOR-TIMI. All subjects meeting the inclusion and exclusion criteria will be assessed. Remaining sample size will be dependent on the number of matched subjects in each cohort using the two data sources combined.

Eligibility criteria

The Eligibility Criteria for CANVAS, LEADER and SAVOR-TIMI are replicated

Please see the Criteria for each under:

•CANVAS: https://clinicaltrials.gov/ct2/show/NCT03936010

•LEADER: https://clinicaltrials.gov/ct2/show/NCT03936049

•SAVOR-TIMI: https://clinicaltrials.gov/ct2/show/NCT03936023

Endpoints (1)

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.

Cardiovascular outcomes

1 endpoint

Primary/protocol endpoint

3-point MACE

Time frame:Follow up begins the day after drug initiation for the three investigated studies [a median of 134-167 days]

3-point MACE

time to event, event

componentsNon-fatal stroke, Non-fatal MI, Cardiovascular death

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.