Effect of Liraglutide on Cardiovascular Endpoints in Diabetes Mellitus Type 2 Patients

Summary

The most important cause of mortality amongst DM2 patients is cardiovascular disease. An early finding of cardiovascular disease in DM2 and obesity is diastolic dysfunction. Diastolic dysfunction is an independent predictor of mortality and has been shown to improve in patients on a low calorie diet. The improvement of diastolic function was associated with a reduction in triglyceride accumulation in the heart and liver. A relatively new widely prescribed therapeutic agent for DM2 patients is Liraglutide (Victoza®). Liraglutide is a Glucagon Like Peptide - 1 homologue that improves glucose homeostasis and reduces blood pressure and body weight. Next to the induction of weight loss, which is potentially beneficial for cardiac function, GLP-1 therapy might have a direct advantageous effect on the cardiovascular system. However, the effect of Liraglutide on cardiovascular function has not been investigated yet. The investigators hypothesize that treatment of DM2 patients with Liraglutide is associated with improvement of cardiovascular function and a reduction of triglyceride accumulation in end-organs.

Conditions

• Diabetes Mellitus Type 2
• Metabolic Syndrome
• Cardiovascular Disease
• Diastolic Dysfunction
• Fatty Liver

Interventions

DRUG

Liraglutide

Preparation and labelling of Investigational Medicinal Product: Liraglutide will be packed and labeled by Novo Nordisk A/S and provided in non-subject specific boxes. Labeling will be in accordance with Annex 13, local law and trial requirements. The examples of labels are not readily available, but will be supplied when received from Novo Nordisk. Drug accountability: Drug accountability will be cared for by the Department of Clinical Pharmacy of the LUMC. The trial product will be dispensed to each subject as required according to treatment group by the clinical pharmacist. No trial product will be dispensed to any person not enrolled in the trial.

DRUG

Liraglutide - Placebo

Preparation and labelling of Investigational Medicinal Product: Liraglutide - Placebo will be packed and labeled by Novo Nordisk A/S and provided in non-subject specific boxes. Labeling will be in accordance with Annex 13, local law and trial requirements. The examples of labels are not readily available, but will be supplied when received from Novo Nordisk. Drug accountability: Drug accountability will be cared for by the Department of Clinical Pharmacy of the LUMC. The trial product will be dispensed to each subject as required according to treatment group by the clinical pharmacist. No trial product will be dispensed to any person not enrolled in the trial.

Sponsors & Collaborators

• Novo Nordisk A/S

  collaborator INDUSTRY

• Leiden University Medical Center

  lead OTHER

Principal Investigators

• Maurice B Bizino, MD · Leiden University Medical Center

• Jan WA Smit, MD PhD · University Nijmegen Medical Centre

• Hildo J Lamb, MD PhD · Leiden University Medical Center

• Albert de Roos, MD PhD · Leiden University Medical Center

• Ingrid M Jazet, MD PhD · Leiden University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2016-03-31

Completion

2016-03-31

Countries

• Netherlands

Study Locations