DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05478707

KML002

SuspendedPhase 2

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

47

estimated

Study population

Type 1 diabetes

Key I/E criteria

•BMI 19-34.9•HbA1c ≤8.5%

Primary endpoint

•Microvascular blood volume (MBV)

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 IDNCT05478707
Org study ID210198

Timeline

Milestones

Study first posted2022-07-28actual
Study start2023-10-05actual
Last update posted2026-04-09actual
Primary completion2028-06-30estimated
Study completion2028-07-30estimated

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•History of type 1 diabetes, duration > 5 years
•Age 18-40 years
•HbA1c < 8.5%
•BMI 19-34.9 kg/m2
•Using insulin for diabetes treatment only (multiple daily injections or insulin pump with or without sensor augmentation)
•On stable regimen of non-diabetic medications for the last 6 months
•All screening labs within normal limits or not clinically significant
•C-peptide <0.6 ng/ml

Exclusion criteria

•Pregnancy or currently breastfeeding
•Smoking history within 6 months
•History of microvascular (microalbuminuria, retinopathy, neuropathy) or macrovascular diabetes complications (coronary artery disease, stroke, peripheral vascular disease) as well as clinically significant cardiac arrhythmias or conduction disorders
•Taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers).
•Known hypersensitivity to perflutren (contained in Definity© contrast)
•Screening O2 saturation <90%
•Musculoskeletal condition preventing participation in exercise testing or exercise training
•Acute or unstable disease other than T1D
•Hypoglycemia unawareness (based on Clarke's questionnaire)
•History of gastroparesis, severe gastroesophageal reflux, pancreatitis, personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
•Anemia (hemoglobin <12 g/dL in women, hemoglobin <13 g/dL in men), eosinophilia (absolute eosinophil count >500 cells/microliter) leukopenia (total white blood cells <4,000 cells/microliter)
•Diabetic ketoacidosis (DKA) on presentation to screening visits or study admission days
•Hospital admission for DKA within 1 year

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

Other (unclassified)
2
Glycemic / diabetes
1
Cardiometabolic biomarkers
1
Other clinical outcomes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Glucose infusion rate (GIR)

Time frame:At baseline and after 14 weeks of treatment

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Brachial artery flow mediated dilation (FMD)

Time frame:At baseline and after 14 weeks of treatment

percent change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Cardiorespiratory fitness, maximum consumption of oxygen (VO2max)

Time frame:At baseline and after 14 weeks of treatment

change from baseline, improvement

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Microvascular blood volume (MBV)

Time frame:At baseline and after 14 weeks of treatment.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Skeletal muscle oxygenation, deoxyhemoglobin (HHb)

Time frame:At baseline and after 14 weeks of treatment. Measured before and after insulin clamp.

change from baseline, descriptive

Publications (58)

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.