Semaglutide Anti-Atherosclerotic Mechanisms of Action Study in Type 2 Diabetes Patients
SAMAS
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2021
CompletedFirst Posted
Study publicly available on registry
December 7, 2021
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMay 24, 2022
May 1, 2022
1 year
November 21, 2021
May 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in morphological arterial wall characteristics
Ultrasonographic assessment of cIMT (in millimetres)
1 year
Change in functional arterial wall characteristics
Endothelial function assessment by EndoPAT
1 year
Change in structural arterial wall characteristics
Arterial stiffness assessment by Sphygmocor device (in meters per second)
1 year
Secondary Outcomes (4)
Change in atherogenic small dense low-density lipoproteins (sdLDL)
1 year
Change in glycated haemoglobin (HbA1c)
1 year
Change in high sensitivity C-reactive protein (hsCRP)
1 year
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
1 year
Study Arms (2)
Interventional Arm
ACTIVE COMPARATORBeside 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.
Comparative Arm
NO INTERVENTIONThis 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.
Interventions
Semaglutide Oral Tablets will be introduced to the active arm as per protocol for regular therapy introduction.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Centre Ljubljanalead
- University of Palermocollaborator
Study Sites (1)
UMC Ljubljana, Diabetes Outpatient Clinic
Ljubljana, Slovenia
Related Publications (1)
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.
PMID: 35258841DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrej Janež, Prof
University Medical Centre Ljubljana
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Prof
Study Record Dates
First Submitted
November 21, 2021
First Posted
December 7, 2021
Study Start
May 1, 2022
Primary Completion
May 1, 2023
Study Completion
December 1, 2023
Last Updated
May 24, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share