Status:
COMPLETED
A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
50+ years
Phase:
PHASE1
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) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2023
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04032197
Start Date
August 12 2019
End Date
June 6 2023
Last Update
April 29 2025
Active Locations (4)
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1
Clinical Trials Unit / Center for Medical Research
Graz, Austria, 8010
2
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730
3
Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl
Stockholm, Sweden, 171 64
4
CTC Clinical Trial Consultants AB, Uppsala
Uppsala, Sweden, 75237