GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT05214573

CompletedResults posted

Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk

Lead sponsor

Mayo Clinic

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

—

Enrollment

386,301

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•3-point Major Adverse Cardiovascular Event (MACE)•Expanded Major Adverse Cardiovascular Events (MACE) and Its Components•Patient Preferences for Second-line Type 2 Diabetes Medication Treatment

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 IDNCT05214573

Org study ID21-007688

Timeline

Milestones

Study start2021-12-01actual

Study first posted2022-01-28actual

Primary completion2023-09-30actual

Study completion2025-07-22actual

Last update posted2025-10-10actual

Results first posted2025-10-10actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Aims 1, 2B, 3: De-identified data sets using laboratory results, electronic health record and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data. Aim 2A: Adults with Type 2 diabetes receiving care from primary care and endocrinology practices in Mayo Clinic Rochester, MN or Mayo Clinic Health System in Minnesota and Wisconsin.

Inclusion criteria

for all Aims

•≥ 21 years old.

•Diagnosis of Type 2 diabetes.

•Use of ≥ 1 study drug (GLP-1RA, SGLT2i, DPP-4i, SU).

Exclusion criteria

for Aims 1, 2B, 3

•Fill for any study drug during the baseline period or simultaneous (within 30 days) start of ≥2 study drugs

•Insulin use

•Type 1 diabetes

•High risk of CVD

•Pregnancy

•Metastatic cancer

Exclusion Criteria for Aim 2A

•Insulin use.

•Cognitive impairment.

•Terminal or advanced illness.

•Non-English speaking.

•Residency in a long-term care setting.

Endpoints (20)

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

Other clinical outcomes

Glycemic / diabetes

Renal / kidney

Safety / tolerability / PK

Patient-reported / QoL

Cardiovascular outcomes

9 endpoints

Primary/registry result

3-point Major Adverse Cardiovascular Event (MACE)

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

descriptive

Posted result

Group	Value (number), Hazard Ratio	95% CI
Aims 1, 2B, and 3 GroupsGLP-1RA versus DPP4i	0.87	0.82 – 0.93
SGLT2i versus DPP4i	0.85	0.81 – 0.90
SU versus DPP4i	1.19	1.16 – 1.22
SGLT2i versus GLP-1RA	0.97	0.90 – 1.05
SU versus GLP-1RA	1.36	1.28 – 1.46
SU versus SGLT2i	1.40	1.33 – 1.47

Primary/registry result

Expanded Major Adverse Cardiovascular Events (MACE) and Its Components

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

descriptive

Posted result

Group	Value (number), Hazard Ratio	95% CI
Aims 1, 2B, and 3 GroupsGLP-1RA versus DPP4i	0.95	0.91 – 1.00
SGLT2i versus DPP4i	0.93	0.89 – 0.96
SU versus DPP4i	1.14	1.12 – 1.17
SGLT2i versus GLP-1RA	0.97	0.92 – 1.02
SU versus GLP-1RA	1.20	1.15 – 1.26
SU versus SGLT2i	1.24	1.20 – 1.28

Primary/protocol endpoint

3-point Major Adverse Cardiovascular Event (MACE)

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

3-point MACE

time to event, event

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

Primary/protocol endpoint

Expanded Major Adverse Cardiovascular Events (MACE) and Its Components

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

5-point MACE

time to event, event

componentsNon-fatal MI, Non-fatal stroke, All-cause death, Heart-failure hospitalization, Coronary revascularization

Secondary/registry result

Non-fatal Myocardial Infarction (MI)

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

descriptive

Posted result

Group	Value (number), Hazard Ratio	95% CI
Aims 1, 2B, and 3 GroupsGLP-1RA versus DPP4i	0.89	0.78 – 1.01
SGLT2i versus DPP4i	0.93	0.85 – 1.02
SU versus DPP4i	1.21	1.15 – 1.26
SGLT2i versus GLP-1RA	1.05	0.91 – 1.21
SU versus GLP-1RA	1.35	1.20 – 1.53
SU versus SGLT2i	1.30	1.19 – 1.41

Secondary/registry result

Non-fatal Stroke Events

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

descriptive

Posted result

Group	Value (number), Hazard Ratio	95% CI
Aims 1, 2B, and 3 GroupsGLP-1RA versus DPP4i	0.89	0.78 – 1.02
SGLT2i versus DPP4i	0.89	0.81 – 0.98
SU versus DPP4i	1.18	1.13 – 1.24
SGLT2i versus GLP-1RA	1.00	0.86 – 1.16
SU versus GLP-1RA	1.33	1.17 – 1.50
SU versus SGLT2i	1.33	1.22 – 1.45

Secondary/protocol endpoint

Non-fatal Myocardial Infarction (MI)

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Non-fatal MI

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Non-fatal Stroke Events

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Non-fatal stroke

time to event, event

SNOMED 230690007

Secondary/protocol endpoint

All-cause Mortality

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

All-cause death

time to event, event

SNOMED 419620001

Glycemic / diabetes

2 endpoints

Primary/registry result

Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes

Time frame:1 hour

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Aim 2A GroupSerious Infection	2	—
Being admitted	2	—
Pancreatitis	3	—
Issues with your feet	4	—
Eye Issues	4	—
Worsening Kidney Function	4	—
Very low blood sugar	4	—
Cancer	7	—
Vessel Blockages	7	—
Stroke	7	—
Amputation	10	—
Heart Attack	10	—
End Stage Kidney Disease (ESKD)	11	—
Death	12	—
Heart Failure	13	—
Blindness	16	—

Secondary/registry result

Treatment for Diabetic Retinopathy or Macular Edema

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

descriptive

Posted result

Group	Value (number), Hazard Ratio	95% CI
Aims 1, 2B, and 3 GroupsSGLT2i versus GLP-1RA	0.73	0.55 – 0.97
SGLT2i versus DPP4i	0.79	0.64 – 0.97
SGLT2i versus SU	0.61	0.50 – 0.74
GLP-1RA versus DPP4i	1.07	0.85 – 1.35
GLP-1RA versus SU	0.83	0.67 – 1.03
SU versus DPP4i	1.29	1.17 – 1.42

Renal / kidney

2 endpoints

Secondary/registry result

Incident End-stage Kidney Disease

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

descriptive

Posted result

Group	Value (number), Hazard Ratio	95% CI
Aims 1, 2B, and 3 GroupsSGLT2i versus DPP4i	0.65	0.56 – 0.76
GLP-1RA versus DPP4i	0.81	0.66 – 0.99
SU versus DPP4i	1.01	0.93 – 1.08
SGLT2i versus SU	0.65	0.56 – 0.75
GLP-1RA versus SU	0.80	0.66 – 0.97
SGLT2i versus GLP-1RA	0.81	0.64 – 1.02

Secondary/protocol endpoint

Incident End-stage Kidney Disease

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

End-stage renal disease

time to event, event

SNOMED 46177005

Patient-reported / QoL

1 endpoint

Primary/protocol endpoint

Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes

Time frame:1 hour

descriptive

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Severe Hypoglycemia

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

descriptive

Posted result

Group	Value (number), Hazard Ratio	95% CI
Aims 1, 2B, and 3 GroupsGLP-1RA versus DPP4i	0.63	0.51 – 0.76
SGLT2i versus DPP4i	0.56	0.46 – 0.68
SU versus DPP4i	2.51	2.29 – 2.75
SGLT2i versus GLP-1RA	0.90	0.70 – 1.16
SU versus GLP-1RA	4.00	3.32 – 4.85
SU versus SGLT2i	4.46	3.73 – 5.32

Secondary/protocol endpoint

Severe Hypoglycemia

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

Severe hypoglycemia

time to event, event

Other clinical outcomes

4 endpoints

Secondary/registry result

All-cause Mortality

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

descriptive

Posted result

Group	Value (number), Hazard Ratio	95% CI
Aims 1, 2B, and 3 GroupsGLP-1RA versus DPP4i	0.86	0.78 – 0.94
SGLT2i versus DPP4i	0.79	0.73 – 0.85
SU versus DPP4i	1.22	1.18 – 1.26
SGLT2i versus GLP-1RA	0.92	0.82 – 1.03
SU versus GLP-1RA	1.42	1.30 – 1.56
SU versus SGLT2i	1.55	1.44 – 1.66

Secondary/registry result

Lower Extremity Complications

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

descriptive

Posted result

Group	Value (number), Hazard Ratio	95% CI
Aims 1, 2B, and 3 GroupsSU versus DPP4i	1.15	1.11 – 1.19
SU versus GLP-1RA	1.20	1.13 – 1.28
SU versus SGLT2i	1.08	1.02 – 1.14
SGLT2i versus GLP-1RA	1.11	1.03 – 1.21
GLP-1RA versus DPP4i	0.96	0.89 – 1.02
SGLT2i versus DPP4i	1.07	1.00 – 1.13

Secondary/protocol endpoint

Treatment for Diabetic Retinopathy or Macular Edema

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

time to event, event

Secondary/protocol endpoint/low confidence

Lower Extremity Complications

Time frame:Retrospective Data between 1/1/2014 - 12/31/2022, up to 8 years, collected over a 2-year period

time to event, event

componentsMajor amputation

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

Comparative effectiveness of sulfonylureas on kidney outcomes in adults with type 2 diabetes and moderate cardiovascular risk: a target trial emulation.
BMJ open diabetes research & care2026 May 21PMID42167878doi:10.1136/bmjdrc-2025-005775via clinicaltrials gov reference derived + pubmed nct search
Kidney Outcomes with Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter 2 Inhibitors, Dipeptidyl Peptidase-4 Inhibitors, and Sulfonylureas in Type 2 Diabetes and Moderate Cardiovascular Risk.
Clinical journal of the American Society of Nephrology : CJASN2025 Feb 1PMID39729347doi:10.2215/CJN.0000000587via clinicaltrials gov reference derived + pubmed nct search
Effectiveness of glucose-lowering medications on cardiovascular outcomes in patients with type 2 diabetes at moderate cardiovascular risk.
Nature cardiovascular research2024 Apr (month)PMID38846711doi:10.1038/s44161-024-00453-9via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.