Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease

Sponsor
RWTH Aachen University
Study ID
NCT04057261
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide Pen Injector [Victoza] — DRUG
    Increasing dose of Liraglutide: 0.6 mg/d for the first week, 1.2 mg/d for the second week aiming for a maximum of 1.8 mg/d beginning with the third week (or highest tolerated dose).Subcutaneous injection once daily via pre-filled pen
  • Placebo — DRUG
    Matching Placebo once daily, subcutaneous injection via pre-filled pen.

Study Details

In an unbiased metabolomics approach with subsequent pathway analyses, the current study seeks to examine the effect of Liraglutide treatment on the metabolic signature in treated patients as well as the effect of Liraglutide on various echocardiographic parameters of cardiac function and rhythm profile, thus paving the way for future research to explain the effects of Liraglutide on cardiovascular mortality and overall mortality in treated patients.

Key Dates

Start date
Nov 30, 2020
Status verified
Mar 2021
Primary completion
Aug 31, 2022
Completion
Nov 30, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Liraglutide
    Increasing dose of Liraglutide: 0.6 mg/d for the first week, 1.2 mg/d for the second week aiming for a maximum of 1.8 mg/d beginning with the third week (or highest tolerated dose).Subcutaneous injection once daily via pre-filled pen.
  • Placebo Comparator: Placebo
    Matching Placebo once daily, subcutaneous injection via pre-filled pen.

Primary Outcome Measure

Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months [ Time Frame: 3 month ]

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