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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05467514

Enrollment

Registered

2022-07-20

Start date

2022-07-01

Completion date

2023-02-28

Last updated

2023-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Liraglutide, Diabetes Mellitus, Type 1, Atherosclerosis

Brief summary

The aim of the trail is investigate the effect of liraglutide 1.8mg as add-on to insulin for 6 months on carotid intima media thickness and cardiovascular risk factors in subjects with type 1 diabetes mellitus.

Interventions

DRUGLiraglutide

Application of liraglutide 1.8 mg subcutaneous daily for 6 months to evaluate subclinical atherosclerosis, by means of carotid doppler US, lipid profile in patients with type 1 diabetes mellitus

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Application of liraglutide 1.8 mg subcutaneous daily for 6 months to evaluate subclinical atherosclerosis, by means of carotid doppler US, lipid profile in patients with type 1 diabetes mellitus

Eligibility

Sex/Gender

ALL

Age

15 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
To assess the effect of liraglutide on carotid intima media thickness in patients with type 1 diabetes mellitus.	Baseline and 6 months	Change from baseline measure of right carotid intima media thickness with doppler ultrasound at 6 months in patients with type 1 diabetes mellitus who meet inclusion criteria.

Secondary

Measure	Time frame	Description
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers (BMI, weight and abdominal circumference)	0, 1, 2, 3, 4, 5 and 6 months	Somatometry: weight will be measured at baseline and every month until completing 6 months.
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. Somatometry (BMI, weight and abdominal circumference)	0, 1, 2, 3, 4, 5 and 6 months	Somatometry: Body mass index will be measured at baseline and every month until completing 6 months.
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (total cholesterol, LDL, HDL, triglycerides, non-HDL cholesterol)	0, 3 and 6 months	Laboratory studies will be taken: complete lipid profile (total cholesterol, LDL, HDL, triglycerides, non-HDL cholesterol) at baseline, 3 and 6 months.
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (HbA1c)	0, 3 and 6 months	Laboratory studies will be taken: HbA1c at baseline, 3 and 6 months.
To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. eGDR (Estimated glucose disposal rate)	0, 3 and 6 months	Estimated glucose disposal rate will be calculated at baseline, 3 and 6 months.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026