Effect of Liraglutide on Vascular Inflammation in Type-2 Diabetes
- Sponsor
- Steno Diabetes Center Copenhagen
- Study ID
- NCT03449654
- Phase
- PHASE4
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Liraglutide — DRUGLiraglutid
- Placebo (for liraglutide) — DRUGPlacebo (for liraglutide)
Study Details
The objective of this study is to evaluate the mechanism behind the anti-atherogenic effects of liraglutide. In a randomized, placebo-controlled, double-blind, parallel trial we will included 100 patients with type 2 diabetes. Patients will be randomized 1:1 to an active treatment period of 26 weeks or placebo for 26 weeks. The primary endpoint is change from baseline to week 26 in vascular inflammation, assessed by Flour Deoxy Glucose (FDG)-Positron Emission Tomography/Computed Tomography (PET/CT)
Key Dates
- Start date
- Oct 26, 2017
- Status verified
- Jun 2020
- Primary completion
- Aug 16, 2019
- Completion
- Aug 16, 2019
Study Design
- Enrollment
- 102 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Other: Liraglutide
- Other: placebo
Primary Outcome Measure
Change in vascular inflammation [ Time Frame: baseline to week 26 ]
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