DelfaGLP-1 Atlas

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Completed

Replication of the LEADER Diabetes Trial in Healthcare Claims

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

168,690

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Expanded / custom MACE composite (Myocardial infarction (any), Stroke (any), All-cause 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 IDNCT03936049
Org study ID2018P002966-DUP-LEADER

Timeline

Milestones

Study start2017-09-22actual
Study first posted2019-05-03actual
Primary completion2021-02-18actual
Study completion2021-02-18actual
Last update posted2023-07-27actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years
Maximum age120 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

This study will involve a new user, parallel group, cohort study design comparing liraglutide to the DPP4 inhibitor (DPP4i) antidiabetic class as a proxy for placebo. Both 2nd generation sulfonylureas (SUs) and DPP4is are not known to have an impact on the outcome of interest. The comparison against DPP4i is the primary comparison. Initiators of 2nd generation SUs are used as a secondary comparator group. The patients will be required to have continuous enrollment during the baseline period of 180 days before initiation of liraglutide or a comparator drug (cohort entry date). Follow-up for the outcome (3P-MACE), begins the day after drug initiation. As in the trial, patients are allowed to take other antidiabetic medications during the study.

Inclusion criteria

Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

Eligible cohort entry dates Market availability of liraglutide in the U.S. started on January 20, 2010. For Marketscan and Medicare: January 20, 2010-Dec 31, 2016 (end of data availability).

For Optum: January 20, 2010-Sep 30, 2017 (end of data availability).

Inclusion Criteria:

•Men or women with type 2 diabetes
•Either of the following:
–Prior cardiovascular disease cohort: Age ≥ 50 years at screening, AND at least one of the following:
–Prior MI
–Prior stroke or TIA
–Prior coronary, carotid or peripheral arterial revascularization
–>50% stenosis of coronary, carotid, or lower extremity arteries coded by Peripheral vascular disease
–Chronic heart failure NYHA class II-III
–CKD stage 3-6 as Chronic renal failure:
•No Prior cardiovascular disease group: Age ≥ 60 years at screening, AND at least one of the following:
–Microalbuminuria or proteinuria
–Hypertension and left ventricular hypertrophy by ECG or imaging
–Ankle-brachial index <0.9

Exclusion criteria

•Type 1 diabetes
•Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any (dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening
•Use of long-term insulin in 90 days prior
•Diabetic ketoacidosis in 3 months prior to index date as Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (e.g., diabetic ketoacidosis) in the previous 3 months
•Inpatient (hospitalization) code for MI, stroke, revascularization, PTCA, CABG IN PRIOR 14 DAYS as An acute coronary or cerebrovascular event in the previous 14 days
•inpatient Heart failure (CHF) as Chronic heart failure NYHA class IV
•ESRD codes as Current continuous renal replacement therapy
•Liver disease as "End stage liver disease, defined as the presence of acute or chronic liver disease and recent history of one or more of the following: ascites, encephalopathy, variceal bleeding, bilirubin ≥ 2.0 mg/dL, albumin level ≤ 3.5 g/dL, prothrombin time ≥ 4 seconds prolonged, international normalised ratio (INR) ≥1.7 or prior liver transplant"
•Organ transplant codes as A prior solid organ transplant or awaiting solid organ transplant
•History of malignant neoplasm in previous 5 years 140.xx-208.xx (except 173.xx, non-melanoma skin cancer)
•Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
•Personal history of non-familial medullary thyroid carcinoma
•Drug abuse or dependence as Known use of non prescribed narcotics or illicit drugs
•Encounter for contraceptive management, Oral contraceptives, and pregnancy as "Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)"

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

Relative hazard of composite outcome of Stroke, MI, and Mortality

Time frame:Through study completion (a median of 154-188 days)

Expanded / custom MACE composite

time to event, event

componentsMyocardial infarction (any), Stroke (any), All-cause death

Publications (1)

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 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.