CompletedPhase 3

Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus

Lead sponsor

David Sanchez Garcia

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 1 diabetes

Eligibility highlights

Primary endpoint

•Effect of liraglutide on carotid intima media thickness

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05467514

Org study IDF-2022-1901-019

Timeline

Milestones

Study start2022-07-01actual

Study first posted2022-07-20actual

Primary completion2023-02-28actual

Study completion2023-02-28actual

Last update posted2023-03-02actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age15 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age from 15 to 60 years

•Patients diagnosed with Type 1 Diabetes Mellitus.

•Diabetes duration more than 1 year.

•Both genders.

•C - peptide less than 0.3 nmol/L

Exclusion criteria

•Patients with type 2 diabetes mellitus, LADA (latent autoimmune diabetes in adults), MODY (maturity-onset diabetes of youth), or other types of diabetes other than type 1 diabetes mellitus.

•Pregnant patients or desire to become pregnant in the next 6 months.

•Family history of medullary thyroid cancer or multiple endocrine neoplasia 2

•History of pancreatitis

•Familial hypercholesterolemia

•Use of adjunctive treatment to insulin (SGLT-2 [sodium-glucose cotransporter-2] inhibitor, Pramlintide, metformin)

•Start of treatment with statins, ezetimibe or PSCK9 (proprotein convertase subtilisin/kexin type 9) inhibitors, amlodipine, metoprolol in the last 6 months before the study.

•Bariatric surgery

•Use of medications (immunosuppressants, calcineurin inhibitors, mTOR (mammilian target of rapamycin) inhibitors, corticosteroids, aspirin, or anticoagulants)

•Metabolic abnormalities (inborn errors of cholesterol storage metabolism, glycogen storage, abetalipoproteinemia, Reye's disease, LCAT (lecithin-cholesterol acyltransferase) deficiency)

Endpoints (7)

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

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

3 endpoints

Secondary/protocol endpoint

To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers (BMI, weight and abdominal circumference)

Time frame:0, 1, 2, 3, 4, 5 and 6 months

change from baseline, improvement

Secondary/protocol endpoint

To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. Somatometry (BMI, weight and abdominal circumference)

Time frame:0, 1, 2, 3, 4, 5 and 6 months

change from baseline, improvement

Secondary/protocol endpoint

To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. Somatometry (BMI, weight and abdominal circumference)

Time frame:0, 1, 2, 3, 4, 5 and 6 months

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (HbA1c)

Time frame:0, 3 and 6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. eGDR (Estimated glucose disposal rate)

Time frame:0, 3 and 6 months

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Primary/protocol endpoint

To assess the effect of liraglutide on carotid intima media thickness in patients with type 1 diabetes mellitus.

Time frame:Baseline and 6 months

change from baseline, improvement

Secondary/protocol endpoint

To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (total cholesterol, LDL, HDL, triglycerides, non-HDL cholesterol)

Time frame:0, 3 and 6 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.