Semaglutide Anti-Atherosclerotic Mechanisms of Action Study in Type 2 Diabetes Patients

NCT ID: NCT05147896

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-12-01

Brief Summary

Diabetes is a chronic disease characterized by chronic hyperglycaemia, causing microvascular and macrovascular complications. The latter lead to various disabilities: blindness, end-stage renal failure, nerve damage, formation of leg ulcers, and atherosclerosis. In people with type 2 diabetes, the probability of these atherosclerosis associated complications is twice as high as in people without diabetes. Cardiovascular diseases are also the main cause of mortality in people with diabetes.

Preventive measures are therefore crucial. In people with type 2 diabetes, in addition to good glycaemic control, the choice of antidiabetic drugs is also important. Large-scale research has shown that certain glucagon-like peptide (GLP-1) receptor agonists, in addition to improving the regulation of diabetes, also have a significant effect on reducing the macrovascular complications. It is now possible to use semaglutide, a GLP-1 receptor agonist, in the tablet form. Semaglutide lowers blood sugar only when the blood sugar value rises, due to food in the digestive tract, Thus, not increasing the risk of hypoglycaemia. In addition, semaglutide has a significant effect on weight loss and very beneficial, protective effects on the cardiovascular system. Large studies have shown that in its injectable form, it significantly reduces the incidence of cardiovascular death in patients with type 2 diabetes.

Therefore, the aim of the present study is to examine how semaglutide provides protective effects on the cardiovascular system and reduces the risk of diabetes type 2 associated complications.

The present study will include 100 people with type 2 diabetes and last for 12 months. The subjects will receive a semaglutide oral tablet daily in addition to their current treatment (combination of metformin and a sulphonyl urea). At the beginning of the study, after 6 months and at the end of the study (after 12 months of treatment), a detailed clinical examination will be performed and blood will be taken for laboratory parameters. In addition to basic blood tests, inflammatory and oxidative stress parameters, as well as lipid fractions parameters will also be assessed. Ultrasound examination of the changes in the carotid arteries and measures of additional properties of the arteries will also be performed. The confidentiality of the data of the participants in the research will be ensured, as the data obtained during the investigation will be encrypted before processing.

Conditions

Diabetes Mellitus, Type 2; Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Interventional Arm

Beside metformin and sulphonyl urea treatment, the active, interventional arm, will be receiving Semaglutide Oral Tablets as per protocol, 3 mg for the first month, 7 mg in the second month and 14 mg form the third month onwards.

Group Type: ACTIVE_COMPARATOR

Semaglutide Oral Tablet

Intervention Type: DRUG

Semaglutide Oral Tablets will be introduced to the active arm as per protocol for regular therapy introduction.

Comparative Arm

This group will not be receiving the additional therapy besides metformin and sulphonyl urea treatment. After 6 months a revaluation of glycemic control will be performed, if needed, rescue therapy with basal insulin will be implemented.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Semaglutide Oral Tablet

Semaglutide Oral Tablets will be introduced to the active arm as per protocol for regular therapy introduction.

Intervention Type: DRUG

Other Intervention Names

Rybelsus

Eligibility Criteria

Inclusion Criteria

• type 2 diabetes
• therapy including at least metformin 1000 mg and sulphonyl urea at least half of the maximal dose
• BMI > or = 30 kg/m2
• HbA1c < or = 8,5%
• associated risk factors including smoking, dyslipidaemia, arterial hypertension, chronic kidney disease stage 1 to 3.

Exclusion Criteria

• therapy with injectable GLP-1 receptor agonist ongoing or was taking place in the last year
• manifested cardiovascular disease
• heart failure
• chronic kidney disease stages 4 and 5
• advanced liver disease
• proliferative retinopathy or maculopathy

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Palermo

OTHER

Sponsor Role: collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Andrej Janez

MD, PhD, Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrej Janež, Prof

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

UMC Ljubljana, Diabetes Outpatient Clinic

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Miodrag Janic, MD, PhD

Role: CONTACT

miodrag.janic@kclj.si

+38640303383

Mojca Lunder, MD, PhD

Role: CONTACT

mojca.lunder@kclj.si

+38641527618

Facility Contacts

Miodrag Janic

Role: primary

miodrag.janic@kclj.si

Mojca Lunder

Role: backup

mojca.lunder@kclj.si

References

Janic M, Rizzo M, Cosentino F, Pantea Stoian A, Lunder M, Sabovic M, Janez A. Effect of Oral Semaglutide on Cardiovascular Parameters and Their Mechanisms in Patients with Type 2 Diabetes: Rationale and Design of the Semaglutide Anti-Atherosclerotic Mechanisms of Action Study (SAMAS). Diabetes Ther. 2022 Apr;13(4):795-810. doi: 10.1007/s13300-022-01226-y. Epub 2022 Mar 8.

Reference Type: DERIVED

PMID: 35258841 (View on PubMed)

Other Identifiers

UMCLjubljana20210043

Identifier Type: -

Identifier Source: org_study_id