DelfaGLP-1 Atlas

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BESTMED

Unknown

BESTMED: Observational Evaluation of Second Line Therapy Medications in Diabetes

Assets

Dulaglutide / Exenatide / GLP-1 / incretin class catch-all / Liraglutide / Semaglutide

Listed sites

5

Recruiting sites

5

Enrollment

550,000

estimated

Study population

Type 2 diabetes

Key I/E criteria

•HbA1c 7-11%•eGFR ≥45

Primary endpoints

•4-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke, Heart-failure hospitalization)•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 IDNCT05161429
Org study ID2021P001171

Timeline

Milestones

Study start2021-07-01actual
Study first posted2021-12-17actual
Last update posted2023-06-22actual
Primary completion2024-06-30estimated
Study completion2024-06-30estimated

Assets

Investigational agents

DulaglutideExenatideGLP-1 / incretin class catch-allLiraglutideSemaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

The study population is adults aged 30 or older who have type 2 diabetes and are at moderate risk of Atherosclerotic Cardiovascular Disease (ASCVD), and who are starting a second diabetes medication (after metformin). Patients from collaborating institutions will be included in the analysis based on study population inclusion and exclusion criteria.

Eligibility criteria

Individuals meeting the following criteria between January 1, 2015 and December 31, 2021:

•Diabetes mellitus (DM) type II
•HbA1c of 7-11% within the past year
•Monotherapy with metformin for at least 3 months
•No prior non-metformin outpatient diabetes therapy
•Aged ≥30y
•At "moderate" risk of ASCVD
–Men aged ≥35y and women aged ≥45y with no history* of stroke, myocardial infarction, revascularization, or heart failure hospitalization
–Men aged 30-34 and women aged 30-44 with history* of hypertension, hyperlipidemia, retinopathy, kidney disease or neuropathy
•estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2 within the past 3 years
•Not pregnant at time 0
•No history* of institutionalization with a diagnosis of dementia, metastatic cancer, end stage lung disease, end stage liver disease, pancreatitis, medullary thyroid cancer or severe UTIs
•Engagement with the healthcare system: enrollment for at least 12 months and attendance of at least one outpatient encounter in the prior 12 months

(*) History will be derived from at least 12 months of EHR and claims prior to time zero and will use all available EHR and claims data between January 1, 2014 and time zero

Endpoints (5)

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
3
Safety / tolerability / PK
1
Other (unclassified)
1

Cardiovascular outcomes

3 endpoints
Primary/protocol endpoint

4-point major adverse cardiac events (MACE)

Time frame:Follow-up begins 30 days after enrollment and ends at the earliest of a) the first study outcome; b) study end or c) loss to follow-up. Maximum duration of follow-up will be 10.5 years.

4-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Heart-failure hospitalization

Primary/protocol endpoint

3-point major adverse cardiac events (MACE)

Time frame:Follow-up begins 30 days after enrollment and ends at the earliest of a) the first study outcome; b) study end or c) loss to follow-up. Maximum duration of follow-up will be 10.5 years.

3-point MACE

time to event, event

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

Secondary/protocol endpoint/low confidence

Severe clinical outcomes

Time frame:Follow-up begins 30 days after enrollment and ends at the earliest of a) the first study outcome; b) study end or c) loss to follow-up. Maximum duration of follow-up will be 10.5 years.

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, All-cause hospitalization

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse outcomes

Time frame:Follow-up begins 30 days after enrollment and ends at the earliest of a) the first study outcome; b) study end or c) loss to follow-up. Maximum duration of follow-up will be 10.5 years.

time to event, event

componentsSevere hypoglycemia, Pancreatitis, Major amputation, All-cause death

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Non-cardiovascular outcomes

Time frame:Follow-up begins 30 days after enrollment and ends at the earliest of a) the first study outcome; b) study end or c) loss to follow-up. Maximum duration of follow-up will be 10.5 years.

composite event, event

componentsCustom renal composite, other clinical outcomes retinopathy treatment, mash liver advanced fibrosis or nash

Publications (3)

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.