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Trial · Interventional

Status unknownPhase 4Registry data

The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)

Short name EGLIPA

NCTNCT02501850 (opens ClinicalTrials.gov in a new tab)Other idVHI-GLP-2014-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
40 participants (estimated)
Sponsor
Hospital Universitari Vall d'Hebron Research Institute · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Spain

Start
Oct 2014
Primary completion
Jul 2015 (estimated)
Completion
Oct 2015 (estimated)
First posted
17 Jul 2015 (estimated)
Last update posted
21 Jul 2015 (estimated)
Conditions
Diabetes Mellitus Type 2

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 4

    EGLIPA

    NCT02501850

    Oct 2014 to est. Oct 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Lipoprotein (a) \[Lp (a)\] is an independent cardiovascular risk (CVR) both in the general population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of CVR. Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R). In addition to lowering blood glucose, these drugs have other beneficial effects. In our laboratory we have demonstrated that both native GLP-1 and various GLP-1R agonsits reduce the synthesis of Lp (a) in hepatocytes. The objective of the study is to test in humans the results observed in vitro. We will analyze whether treatment with GLP-1R agonists (Liraglutide, Exenatide or Lixisenatida) will reduce serum levels of Lp (a) in patients with DM-2.

Interventions

  • LiraglutideDrug
  • metforminDrug

Arms2

  • Experimental

    Group A

    Type 2 diabetic patients whom were prescribed GLP-1R agonists by the endocrinologist, according to usual clinical practice (liraglutide, exenatide, lixisenatide). The intervention is the prescription of an GLP-1R agonist (liraglutide, exenatide, lixisenatide)

  • Active comparator

    Group B

    Type 2 diabetic patients whom were prescribed metformin and/or sulphonilurea, according to usual clinical practice.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in blood levels of Lipoprotein (a) (Lp(a))

    Time frame · Baseline and two months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 2 diabetes * age between 50-65 years * written informed consent Exclusion Criteria: * active GLP-1R agonist, insulin or DPP-IV treatment. * Liver failure (3lsn AST and/or ALT) * Kidney failure (FG \<30ml/min/1,73m2), * HbA1c\> 10% * LDL-cholesterol\> 180 mg/dl * Triglycerides\> 350 mg/dl

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