| Trial ID: | L7056 |
| Source ID: | NCT04032197
|
| Associated Drug: |
Semaglutide
|
| Title: |
A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Semaglutide|DRUG: Placebo (semaglutide)
|
| Outcome Measures: |
Primary: Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries, Ratio, From baseline (from 41 days before randomisation) to week 26 | Secondary: Change in maximum target-to-background ratio (TBR) for 68Ga-DOTATATE in the carotid arteries, Ratio, From baseline (from 40 days before randomisation) to week 26|Change in total wall volume of the most diseased carotid artery, mm3, From baseline (from 41 days before randomisation) to week 52|Change in lipid rich necrotic core (LRNC) volume of the atherosclerotic plaque in the most diseased carotid artery, mm3, From baseline (from 41 days before randomisation) to week 52|Change in average fibrous cap thickness (FCT) of the atherosclerotic plaque in the most diseased carotid artery, mm, From baseline (from 41 days before randomisation) to week 52
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
101
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-08-12
|
| Completion Date: |
2023-06-06
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-03
|
| Locations: |
Clinical Trials Unit / Center for Medical Research, Graz, 8010, Austria|Steno Diabetes Center Copenhagen, Herlev, 2730, Denmark|Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl, Stockholm, 171 76, Sweden|CTC Clinical Trial Consultants AB, Uppsala, Uppsala, 75237, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT04032197
|
