DelfaGLP-1 Atlas

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Completed

Replication of the LEAD-2 Diabetes Trial in Healthcare Claims Data

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

3,474

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•HbA1c, change

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 IDNCT05162183
Org study ID2018P002966-DUP-LEAD2

Timeline

Milestones

Study start2019-09-01actual
Primary completion2021-09-01actual
Study completion2021-09-01actual
Study first posted2021-12-17actual
Last update posted2023-07-27actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

This study will involve a new user, parallel group, propensity score-matched, retrospective cohort design comparing injectable subcutaneous liraglutide (1.2 or 1.8 mg/day) to oral glimepiride (4 mg once daily). Treatments in both arms are administered in combination with metformin (up to 2,000 mg/day). Patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of liraglutide or glimepiride. The analyses will be restricted to individuals with type 2 diabetes mellitus who have been previously treated with antidiabetic drugs. In the replication, previous anti-diabetic treatment was defined as the presence of at least 2 prescriptions for metformin within 6 months before and including cohort entry.

Inclusion criteria

•Diagnosis of Type 2 Diabetes mellitus [0,0] days
•3 or more recorded HbA1c values [-365, 0] days
•At least two dispensing claims for metformin [-180,0] days
•1 or more recorded HbA1c values [-90,0] days
•Age between 18-80 [0,0] days

Exclusion criteria

•Cancer, malignant neoplasm, or MEN2 [-1,825,0] days
•Use of other anti-diabetic medications [-180,0] days
•Cirrhosis or Hepatic decompensation [-180,0] days
•Viral hepatitis B or C [-180,0] days
•Stage 5 CKD, ESRD, dialysis or renal transplant [-180,0] days
•MI or HF [-180,0] days
•Treatment with Anti-VEGFi or Photocoagulation [-180,0] days
•Hypertensive crisis or uncontrolled hypertension [-180,0] days
•Two diagnoses of hypoglycemia [-180,0] days
•Alcohol/drug abuse/dependence [-180,0] days
•Dementia and brain damages or non-compliance [-180,0] days
•Pregnancy [-180,0] days
•Type 1 DM, DKA, or other metabolic acidosis [-180,0] days
•Systemic corticosteroids [-90,0] days

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.

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Relative Hazard of change in HbA1c from baseline to 26 weeks of treatment (end of follow-up)

Time frame:26-week follow-up window with a median follow-up time of 99 [84, 148] days

HbA1c, change

change from baseline, improvement

LOINC 4548-4

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.