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Trial · Interventional

CompletedPhase 4Registry data

Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity

NCTNCT02909933 (opens ClinicalTrials.gov in a new tab)Other idCOMBO - LIRA 3
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
30 participants (actual)
Sponsor
University Medical Centre Ljubljana · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Slovenia

Start
Jul 2015
Primary completion
Oct 2015
Completion
Oct 2015
First posted
21 Sept 2016 (estimated)
Last update posted
21 Sept 2016 (estimated)
Conditions
Polycystic Ovary Syndrome · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016
  1. Ph 4

    Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity

    NCT02909933

    Jul 2015 to Oct 2015

Registry summary

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

Weight reduction is the most important treatment target when polycystic ovary syndrome (PCOS) is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide. We investigates short term interventions with low dose liraglutide in combination with metformin and high dose liraglutide alone influence on significant weight reduction in obese women with PCOS.

Interventions

  • liraglutideDrug
  • metformin and liraglutideDrug

Arms2

  • Experimental

    liraglutide

    liraglutide 3 mg QD for 12 weeks

  • Experimental

    metformin and liraglutide

    metformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The main outcome was change in body weight.

    Time frame · Patient's body weight was measured at the base point and after 12 weeks of clinical trial.

Secondary outcomes(1)

  1. The secondary outcome was change in body mass index (BMI)

    Time frame · Patient's body weight were measured at the base point and after 12 weeks of clinical trial. Patient's height was measured at the base point.

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.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

8 results

Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial.

Jensterle et al. 2017BMC endocrine disorderscited by 58

PMID 28143456PMC5286837DOI 10.1186/s12902-017-0155-9PUB-28143456

CC BY8 results
Download PDFSee results (8)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 18 years old to menopause * polycystic ovary syndrome (NICHD criteria) * BMI of 30 kg/m² or higher Exclusion Criteria: * type 1 or type 2 diabetes mellitus * history of carcinoma * Cushing's syndrome or congenital (non-classic) adrenal hyperplasia * personal or family history of MEN 2 * significant cardiovascular, kidney or hepatic disease * the use of medications known or suspected to affect reproductive or metabolic functions * the use of statins, within 90 days prior to study entry

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