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Trial · Interventional

CompletedPhase 4Registry data

Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin

NCTNCT01911468 (opens ClinicalTrials.gov in a new tab)Other id20120047-LIRA1
Open at ClinicalTrials.govAsk about this trial

Overview

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

Slovenia

Start
Nov 2011
Primary completion
Oct 2012
Completion
Apr 2013
First posted
30 Jul 2013 (estimated)
Last update posted
30 Jul 2013 (estimated)
Conditions
PCOS · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014
  1. Ph 4

    Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin

    NCT01911468

    Nov 2011 to Apr 2013

Registry summary

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

The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than liraglutide or metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with liraglutide or metformin.

Interventions

  • metforminDrug
  • liraglutideDrug
  • metformin and liraglutideDrug

Arms3

  • Active comparator

    metformin

    In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os.

  • Active comparator

    liraglutide

    In the liraglutide group liraglutide was initiated at a dose of 0.6 mg injected sc once per day and increased to 1.2 mg/day after 1 week.

  • Active comparator

    metformin and liraglutide

    In the metformin and liraglutide group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os. At the same time liraglutide was initiated at a dose of 0.6 mg injected sc once per day and increased to 1.2 mg/day after 1 week.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The main outcome was change in body weight.

    Time frame · Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.

Secondary outcomes(2)

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

    Time frame · Patient's body weight were measured at the basepoint and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint.

    Registry description

    Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.

  2. The secondary outcome was change in waist circumference.

    Time frame · Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.

    Registry description

    Patient's waist circumference was measured in centimeters.

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: Clinical trial · 2015

6 results

Short-term intervention with liraglutide improved eating behavior in obese women with polycystic ovary syndrome.

Jensterle et al. 2015Endocrine researchcited by 66

PMID 25330463DOI 10.3109/07435800.2014.966385PUB-25330463

Full text at the publisher6 results
Publisher pageSee results (6)

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 * poor response to previous treatment with metformin for at least 3 months 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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