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

Diabetes Mellitus, Type 2 Clinical Trial

— SAMAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05147896
• Other study ID #: UMCLjubljana20210043
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2022
• Source: University Medical Centre Ljubljana
• Contact: Miodrag Janic, MD, PhD
• Phone: +38640303383
• Email: miodrag.janic[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana, Diabetes Outpatient Clinic	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Palermo

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in morphological arterial wall characteristics	Ultrasonographic assessment of cIMT (in millimetres)	1 year
Primary	Change in functional arterial wall characteristics	Endothelial function assessment by EndoPAT	1 year
Primary	Change in structural arterial wall characteristics	Arterial stiffness assessment by Sphygmocor device (in meters per second)	1 year
Secondary	Change in atherogenic small dense low-density lipoproteins (sdLDL)	Assessment by gel electrophoresis	1 year
Secondary	Change in glycated haemoglobin (HbA1c)	Assessment by biochemical methods	1 year
Secondary	Change in high sensitivity C-reactive protein (hsCRP)	Assessment by biochemical methods	1 year
Secondary	Correlations between changes in rate of cIMT reduction, % of endothelial function improvement and rate of arterial stiffness reduction on one hand and changes in concentration of sdLDL, % of HbA1c and concentration of hsCRP on the other	Statistical methods	1 year