Clinical trial NCT04032197: A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes
Official title: A Trial Investigating the Effect of Semaglutide on Atherosclerosis in Patients With Cardiovascular Disease and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-07-25
Enrollment: 101
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looks into how the type 2 diabetes medicine, semaglutide, can prevent risk of heart disease complications and stroke. Participants will either get semaglutide or placebo ("dummy" medicine) - which treatment is decided by chance. Semaglutide is a new medicine to treat type 2 diabetes and can be prescribed by doctors in some countries. The study medicine will be in a pen, and must be injected with a needle in the stomach, thigh or upper arm once a week. The study will last for 57-63 weeks. Participants will have 10 clinic visits with the study doctor, 5 visits to the specialised clinic for imaging and at least 1 phone contact. Participants' health will be monitored carefully and blood samples will therefore be taken at the clinic visits. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility criteria: Inclusion Criteria:

* Male or female, age above or equal to 50 years at the time of signing informed consent
* Body mass index equal to or less than 39.9 kg/m\^2
* Diagnosed with type 2 diabetes 180 daysor more prior to the day of the first screening visit
* HbA1c 6.0% - 9.0% (42-75 mmol/mol) (both inclusive)
* Established cardiovascular disease

Exclusion Criteria:

* Hospitalisation for unstable angina pectoris or transient ischaemic attack within 90 days prior to the day of the first screening visit
* Planned coronary, carotid or peripheral artery revascularisation.
* Presently classified as being in New York Heart Association (NYHA) equal to or above Class III
* Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or systemic anti-inflammatory drugs within 90 days prior to the first screening visit. Stable treatment with acetylsalicylic acid for prevention of cardiovascular events and occasional use of propionic acid derivatives drugs (e.g. ibuprofen) is allowed

Primary outcomes:
measure: Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries
timeFrame: From baseline (from 41 days before randomisation) to week 26
Secondary outcomes:
measure: Change in maximum target-to-background ratio (TBR) for 68Ga-DOTATATE in the carotid arteries
timeFrame: From baseline (from 40 days before randomisation) to week 26
measure: Change in total wall volume of the most diseased carotid artery
timeFrame: From baseline (from 41 days before randomisation) to week 52
measure: Change in lipid rich necrotic core (LRNC) volume of the atherosclerotic plaque in the most diseased carotid artery
timeFrame: From baseline (from 41 days before randomisation) to week 52
measure: Change in average fibrous cap thickness (FCT) of the atherosclerotic plaque in the most diseased carotid artery
timeFrame: From baseline (from 41 days before randomisation) to week 52
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Clinical Trials Unit / Center for Medical Research
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl
city: Uppsala
country: Sweden
facility: CTC Clinical Trial Consultants AB, Uppsala
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: