Effect of Liraglutide on Diastolic Dysfunction on Cardiac MRI in Type 2 Diabetes Patients

Sponsor
Rigshospitalet, Denmark
Study ID
NCT02655770
Phase
PHASE4
Status
Completed

Conditions

  • Cardiac MRI
  • Diabetes Mellitus Type 2
  • Diastolic Dysfunction
  • Myocardial Perfusion

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac MRI. Secondary if the treatment has any effect on the perfusion of the heart on a cardiac-MRI.

Key Dates

Start date
Feb 29, 2016
Status verified
Jan 2021
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Liraglutide arm
    Patients will be treated with liraglutide (up to 1.8 mg s.c. once daily). Total treatment period will be 18 weeks.
  • Placebo Comparator: Placebo arm
    Patients will be treated with placebo (up to equal to 1.8 mg drug dose s.c. once daily). Total treatment period will be 18 weeks. The study will be placebo-controlled with placebo as an add-on to conventional diabetes treatment. Thus, no patient will receive a sub-standard treatment.

Primary Outcome Measure

Change in diastolic properties as assessed by CMR. [ Time Frame: Measured in week 18 and compared to baseline. ]

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