← Trials/Trial dossier/NCT05597202

DOTAFLAME

UnknownPhase 4

Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Coronary 68Ga-Dotatate uptake after 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 IDNCT05597202

Org study IDNL80519.018.22

Timeline

Milestones

Study first posted2022-10-27actual

Study start2023-01-01actual

Last update posted2023-05-09actual

Primary completion2024-03estimated (month precision)

Study completion2024-04estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age >50 years old

•Diagnosed with type 2 diabetes

•HbA1c >64mmol/mol

Exclusion criteria

1. (History of) malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.

2. Chronic or recent infections and/or clinical signs of infection and/or a plasma C-reactive protein above 10ng/ml

3. Auto-immune diseases (including type 1 diabetes)

4. Recent or chronic immunosuppressant or antibiotic usage

5. Use of any GLP1R-agonist at baseline or prior intolerance to use of GLP1R-agonists.

6. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

7. Uncontrolled hypertension (systolic blood pressure > 180mmHg, diastolic blood pressure > 100mmHg)

8. Uncontrolled chronic inflammatory conditions, including gout.

9. Women of childbearing age who are not using effective contraceptives.

10. Heart failure New York Heart Association (NYHA) class IV at screening visit.

11. Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) ≥ 2 times the upper limit of normal (ULN) at screening visit.

12. Pancreatitis in medical history.

Endpoints (2)

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

Cardiometabolic biomarkers

Other (unclassified)

Cardiometabolic biomarkers

1 endpoint

Primary/protocol endpoint

Difference in coronary 68Ga-Dotatate uptake after treatment.

Time frame:6 months

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Difference in bone marrow aspirates after treatment.

Time frame:6 months

change from baseline, 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.