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CER-4-T2D

Active not recruiting

Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study

Lead sponsor

Brigham and Women's Hospital

Assets

Albiglutide / Dulaglutide / Exenatide / Liraglutide / Lixisenatide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

781,430

estimated

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•3-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke)•Expanded / custom MACE composite (Myocardial infarction (any), Ischemic stroke, All-cause death)•Heart-failure hospitalization

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 IDNCT05220917

Org study ID2021P001784

Timeline

Milestones

Study start2021-08-01actual

Study first posted2022-02-02actual

Last update posted2026-05-15actual

Primary completion2026-05-31estimated

Study completion2027-09-30estimated

Assets

Investigational agents

Albiglutide Dulaglutide Exenatide Liraglutide Lixisenatide Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Optum and MarketScan databases are U.S. research claims databases that include adults with employer-based health plans, with nationwide coverage for over 60 million Americans, and meaningful numbers of patients ≥65 years from Medicare Advantage plans, employer-sponsored plans covering seniors, and Medicare supplemental insurance plans. Medicare FFS is a U.S. federal health insurance program providing coverage to individuals ≥65 years and to younger individuals with disabilities. The Partners RPDR captures longitudinal EHR data for all patients that receive care at 2 large health care provider networks in the Boston metro area. The VHA is the largest integrated national health system, serving over 12 million U.S. Veterans. The VHA database includes demographic, diagnostic and procedure information from inpatient/outpatient encounters. The CPRD is comprised of two large, computerized databases of longitudinal primary care records, GOLD and Aurum, for \>50 million UK patients.

Inclusion criteria

•Age ≥ 18 years for Optum Cliniformatics, IBM Marketscan, CPRD, and VHA, and ≥ 65 years for Medicare FFS at cohort entry

•At least 12 months of continuous health plan enrollment (only claims) or registration with a general practitioner (CPRD) before and including cohort entry

•Diagnosis of T2D within 12 months before (or ever before in CPRD) and including cohort entry

•Low or moderate cardiovascular (CV) risk (≤3% risk of CV events/year) at cohort entry *

•Metformin maintenance therapy, defined as 2 fills (or prescriptions in CPRD) of metformin monotherapy recorded within 6 months before and including cohort entry

Exclusion criteria

•Missing age or gender information

•Nursing care admission within 12 months before and including cohort entry (criteria ignored in CPRD)

•Diagnosis of type 1 diabetes within 12 months before and including cohort entry

•Diagnosis of secondary or gestational diabetes within 12 months before and including cohort entry

•Any insulin fill or prescription within 12 months before and including cohort entry

•Diagnosis of end stage renal disease (stage ≥ 5) within 12 months before and including cohort entry

•Diagnosis of acute or chronic pancreatitis within 12 months before and including cohort entry

•Diagnosis of cirrhosis or acute hepatitis within 12 months before and including cohort entry

•Diagnosis of MEN-2 within 12 months before and including cohort entry

•Recorded solid organ transplant code within 12 months before and including cohort entry

•Patients with recorded initiation of more than one agent within a comparator class at cohort entry

Endpoints (30)

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

Safety / tolerability / PK

Cardiovascular outcomes

Renal / kidney

Glycemic / diabetes

Other clinical outcomes

Weight & body composition

Heart failure

Other (unclassified)

Cardiovascular outcomes

8 endpoints

Primary/protocol endpoint

MACE

Time frame:through study completion, an average of 1 year

3-point MACE

time to event, event

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

Primary/protocol endpoint

Modified MACE

Time frame:through study completion, an average of 1 year

Expanded / custom MACE composite

composite event, event

componentsMyocardial infarction (any), Ischemic stroke, All-cause death

Secondary/protocol endpoint

Myocardial Infarction (MI)

Time frame:through study completion, an average of 1 year

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Stroke

Time frame:through study completion, an average of 1 year

Stroke (any)

time to event, event

SNOMED 230690007

Secondary/protocol endpoint

Cardiovascular Mortality

Time frame:through study completion, an average of 1 year

Cardiovascular death

time to event, event

Secondary/protocol endpoint

All-cause mortality

Time frame:through study completion, an average of 1 year

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Coronary revascularization

Time frame:through study completion, an average of 1 year

Coronary revascularization

time to event, event

SNOMED 415070008

Other/protocol endpoint

Lower-limb amputations

Time frame:through study completion, an average of 1 year

Major amputation

event count, event

Weight & body composition

1 endpoint

Other/protocol endpoint

Weight loss or gain

Time frame:through study completion, an average of 1 year

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Other/protocol endpoint

Glycemic control

Time frame:through study completion, an average of 1 year

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

Insulin initiation

Time frame:through study completion, an average of 1 year

time to event, event

Heart failure

1 endpoint

Primary/protocol endpoint

Hospitalization for Heart Failure (HHF) Hospitalization for Heart Failure (HHF)

Time frame:through study completion, an average of 1 year

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Renal / kidney

6 endpoints

Other/protocol endpoint

CKD progression

Time frame:through study completion, an average of 1 year

Custom renal composite

composite event, event

componentseGFR, change, Kidney-replacement therapy, Renal death

Other/protocol endpoint

Sustained decrease in eGFR

Time frame:through study completion, an average of 1 year

eGFR, change

change from baseline, improvement

LOINC 98979-8

Other/protocol endpoint

Kidney replacement therapy (KRT)

Time frame:through study completion, an average of 1 year

Kidney-replacement therapy

time to event, event

Other/protocol endpoint

Kidney death

Time frame:through study completion, an average of 1 year

Renal death

time to event, event

Other/protocol endpoint

Kidney failure

Time frame:through study completion, an average of 1 year

End-stage renal disease

composite event, event

componentseGFR, change, Kidney-replacement therapy

SNOMED 46177005

Other/protocol endpoint

Early kidney disease

Time frame:through study completion, an average of 1 year

eGFR, change

change from baseline, improvement

LOINC 98979-8

Safety / tolerability / PK

9 endpoints

Other/protocol endpoint

Diabetic ketoacidosis

Time frame:through study completion, an average of 1 year

event count, event

Other/protocol endpoint

Bone fractures

Time frame:through study completion, an average of 1 year

event count, event

Other/protocol endpoint

Acute kidney injury

Time frame:through study completion, an average of 1 year

time to event, event

Other/protocol endpoint

Urinary infections

Time frame:through study completion, an average of 1 year

descriptive, event

Other/protocol endpoint

Genital infections

Time frame:through study completion, an average of 1 year

descriptive, event

Other/protocol endpoint

Acute pancreatitis

Time frame:through study completion, an average of 1 year

Pancreatitis

descriptive, event

Other/protocol endpoint

Biliary events

Time frame:through study completion, an average of 1 year

Gallbladder event

descriptive, event

Other/protocol endpoint

Severe hypoglycemia

Time frame:through study completion, an average of 1 year

Severe hypoglycemia

event count, event

Other/protocol endpoint

Medication persistence

Time frame:through study completion, an average of 1 year

time to event, descriptive

Other clinical outcomes

2 endpoints

Other/protocol endpoint/low confidence

Short-term retinopathy progression

Time frame:through study completion, an average of 1 year

categorical status, event

Other/protocol endpoint/low confidence

Home time

Time frame:through study completion, an average of 1 year

descriptive

Other (unclassified)

1 endpoint

Other/protocol endpoint/low confidence

Switching patterns

Time frame:through study completion, an average of 1 year

descriptive

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.