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Liraglutide as Add on Therapy on Metformin in Women With Polycystic Ovary Syndrome

Sponsor
University Medical Centre Ljubljana (Other)
Overall Status
Completed
CT.gov ID
NCT02483299
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
14.9
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Metformin
Other Names:
  • Glucophage tablets

    		•
    Active Comparator: combined

    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.

    Drug: Glucophage tablets and Victoza
    Other Names:
  • Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in body weight [up to 12 weeks of clinical trial]

    2. The number of good responders to combined treatment regarding body weight [up to 12 weeks of clinical trial]

    Secondary Outcome Measures

    1. Change in body mass index (BMI). [up to 12 weeks of clinical trial]

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

    2. Change in waist circumference [up to 12 weeks of clinical trial]

      waist circumference was measured in centimeters.

    Other Outcome Measures

    1. Change in fasting concentrations of glucose [up to 12 weeks of clinical trial]

      Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.

    2. Change in fasting concentration of insulin [up to 12 weeks of clinical trial]

      Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.

    3. Change in blood concentrations of LH (luteinizing hormone) [up to 12 weeks of clinical trial]

      Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L.

    4. Change in blood concentrations of FSH (follicle-stimulating hormone) [up to 12 weeks of clinical trial]

      Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L.

    5. Change in blood concentration of testosterone [up to 12 weeks of clinical trial]

      Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.

    6. Change in blood concentration in androstenedione [up to 12 weeks of clinical trial]

      Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L.

    7. Change in blood concentrations of SHBG (sex hormone-binding globulin) [up to 12 weeks of clinical trial]

      Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L.

    8. Change in blood concentration of DHEAS (dehydroepiandrosterone sulfate) [up to 12 weeks of clinical trial]

      Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Ljubljana Ljubljana Slovenia 1000

    Sponsors and Collaborators

    • University Medical Centre Ljubljana

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrej Janez, professor, MD, PhD, University Medical Centre Ljubljana
    ClinicalTrials.gov Identifier:
    NCT02483299
    Other Study ID Numbers:
    • LIRA COMBI
    First Posted:
    Jun 26, 2015
    Last Update Posted:
    Jun 26, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Andrej Janez, professor, MD, PhD, University Medical Centre Ljubljana
    response to therapy
    Additional relevant MeSH terms:
    Metformin
    Liraglutide

    Study Results

    No Results Posted as of Jun 26, 2015