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

Status

Completed

Phase

Phase 4

Enrollment

50 participants (actual)

Sponsor

Leiden University Medical Center · Other

Design

Randomized · Quadruple masking

Countries

1 country

Netherlands

Start

Nov 2013

Primary completion

Mar 2016

Completion

Mar 2016

First posted

4 Jan 2013 (estimated)

Last update posted

5 May 2016 (estimated)

Conditions

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

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.

• Active comparator

  Liraglutide

  Liraglutide: Solution for subcutaneous injection 6 mg/ml; Flexpen 3 ml. Dose: s.c. 0,6 mg (0,1 mL) once daily. After 1 week, the dose will be increased to 1,2 mg (0,2 mL) once daily. If tolerated, after 1 week, dose will be increased to 1.8 mg (0,3 mL) once daily. In case of a hypoglycaemic episode, the dosage of oral blood glucose lowering medicaments will be adjusted first. If hypoglycaemia persists, Liraglutide / Liraglutide placebo will be adjusted on the basis of clinical parameters. Duration: 26 weeks

• Placebo comparator

  Liraglutide-placebo

  Liraglutide placebo: Solution for injection; Flexpen 3 ml. Dosage: same as Liraglutide Duration: 26 weeks

1. Stroke volume

   Time frame · 0 and 26 weeks

   Registry description

   Change from baseline in ml: difference between groups

2. Ejection Fraction

   Time frame · 0 and 26 weeks

   Registry description

   Change from baseline in percentage: difference between groups

3. Cardiac output

   Time frame · 0 and 26 weeks

   Registry description

   Change from baseline in L/min: difference between groups

4. Cardiac index

   Time frame · 0 and 26 weeks

   Registry description

   Change from baseline in L/min/m2: difference between groups

5. Peak ejection rate

   Time frame · 0 and 26 weeks

   Registry description

   Change from baseline in ml end-diastolic volume/sec: difference between groups

6. Early peak filling rate

   Time frame · 0 and 26 weeks

   Registry description

   Change from baseline in ml end-diastolic volume/sec: difference between groups

7. Early deceleration peak

   Time frame · 0 and 26 weeks

   Registry description

   Change from baseline in ml/sec: difference between groups

8. Atrial peak filling rate

   Time frame · 0 and 26 weeks

   Registry description

   Change from baseline in ml/sec: difference between groups

9. Early deceleration peak / Atrial peak filling rate (E/A ratio)

   Time frame · 0 and 26 weeks

   Registry description

   Change from baseline of the ratio: difference between groups

10. Peak mitral annulus longitudinal motion

    Time frame · 0 and 26 weeks

    Registry description

    Change from baseline in cm/sec: difference between groups

11. Left ventricular filling pressure (= early peak filling rate / peak mitral annulus longitudinal motion)

    Time frame · 0 and 26 weeks

    Registry description

    Change from baseline in mmHg: difference between groups