GLP-1 Peptide Atlas, by Delfa

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Cardiovascular Outcomes and HbA1c Among Patients With Type 2 Diabetes Newly Initiating GLP1RAs vs Basal Insulin

An Observational Study of Glycemic Control and Cardiovascular Outcomes Among Patients With Type 2 Diabetes Newly Initiating Glucagon-like Peptide-1 Receptor Agonists (GLP1) Versus Basal Insulin in Routine Care Settings

Lead sponsor

Brigham and Women's Hospital

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

20,000

estimated

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Expanded / custom MACE composite (Myocardial infarction (any), Stroke (any))

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 IDNCT04034524

Org study ID2011P002580-118

Timeline

Milestones

Study start2019-05-01actual

Study first posted2019-07-26actual

Last update posted2020-07-09actual

Primary completion2020-12-31estimated

Study completion2020-12-31estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Sampling methodNon probability sample

Study population text

Patients with type 2 diabetes with prior and concomitant use of metformin and other oral anti diabetic agents

Inclusion criteria

•Age>=18 years

•at least 180 days of continuous enrollment prior to index date

•at least 1 Type 2 diabetes diagnosis code prior to index date

•(for cohort #1) at least 2 metformin dispensings prior to index date AND days supply overlap on cohort entry date (with 14 days of grace period before)

Exclusion criteria

•any type 1 diabetes diagnosis code prior to index date

•medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (both black box warnings) prior to index date

•h/o pancreatitis

•h/o recurrent hypoglycemia (i.e. more than 1 hospitalization / emergency department encounter in primary diagnosis position for hypoglycemia)

•index injectable is a combination of GLP1-RA plus insulin

•index GLP1-RA is Saxenda (indicated for weight loss) or liraglutide at 3.0mg dose

•index insulin regimen includes both basal and prandial insulin, or premixed insulin

•Any prior GLP1-RA use (Applied washout for 180 days)

•Any prior insulin use; Sometimes insulin is transiently used at diagnosis (Applied washout for 180 days)

•Secondary diabetes

•Gestational diabetes

•Nursing home admission (because we don't have pharmacy claims)

•Age <18 years

•Chronic kidney disease stage 4-6

•Advanced cancer

•End stage renal disease

For A1c cohort only:

-HbA1c >12%

Endpoints (9)

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

Glycemic / diabetes

Safety / tolerability / PK

Cardiovascular outcomes

3 endpoints

Primary/protocol endpoint

Time until first composite CV event (myocardial infarction, stroke)

Time frame:Through Study Completion, an estimated average of 1 year

Expanded / custom MACE composite

time to event, event

componentsMyocardial infarction (any), Stroke (any)

Secondary/protocol endpoint

Time until first myocardial infarction

Time frame:Through Study Completion, an estimated average of 1 year

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Time until first stroke

Time frame:Through Study Completion, an estimated average of 1 year

Stroke (any)

time to event, event

SNOMED 230690007

Glycemic / diabetes

3 endpoints

Other/protocol endpoint

Proportion of patients with HbA1c post-index < 7% (EAGLE)

Time frame:24 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Other/protocol endpoint

Proportion of patients with HbA1c post-index < 8% (EAGLE)

Time frame:24 weeks

threshold achievement, improvement

LOINC 4548-4

Other/protocol endpoint

Change from baseline HbA1c

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Time until first serious hypoglycemic event

Time frame:Through Study Completion, an estimated average of 1 year

Severe hypoglycemia

time to event, event

Secondary/protocol endpoint

Time until first episode of acute pancreatitis

Time frame:Through Study Completion, an estimated average of 1 year

Pancreatitis

time to event, event

Secondary/protocol endpoint

Time until first episode of acute cholecystitis

Time frame:Through Study Completion, an estimated average of 1 year

Gallbladder event

time to event, event

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.