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

NCT04057261 · Withdrawn

Last updated 2026-05-28

This clinical trial tested the effects of the medication liraglutide on the blood chemistry of adults with type 2 diabetes and heart disease over 1 and 3 months.

Status Withdrawn Stopped before any participant enrolled.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind study

Who can join Ages 18+ · all sexes

Timeline Started 2020-11 · est. completion 2022-11

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT04057261 ↗

Description as written by the study sponsor.

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.

Treatments tested

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.

Main thing measured	Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months
Sponsor	RWTH Aachen University
Conditions studied	Type 2 Diabetes, Cardiovascular Diseases
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04057261 ↗