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

NCT05467514 | Completed Phase 3 DMC

• 1 other identifier: F-2022-1901-019
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Liraglutide; Diabetes Mellitus, Type 1; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and 6 months

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

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

  0, 3 and 6 months

Study Arms (1)

Liraglutide

EXPERIMENTAL

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

Drug: Liraglutide

Interventions

Liraglutide DRUG

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

Liraglutide

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• David Sanchez Garcia: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25

Monterrey, Nuevo León, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Atherosclerosis

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator David Sanchez Garcia

Model Details: 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 Record Dates

• First Submitted: July 7, 2022
• First Posted: July 20, 2022
• Study Start: July 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

ME (1)