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

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ClinicalTrials.gov Identifier: NCT02483299
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Andrej Janez, University Medical Centre Ljubljana

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
PCOS Obesity Drug: Metformin Drug: Glucophage tablets and Victoza Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: up to 12 weeks of clinical trial ]
  2. The number of good responders to combined treatment regarding body weight [ Time Frame: up to 12 weeks of clinical trial ]

Secondary Outcome Measures :
  1. Change in body mass index (BMI). [ Time Frame: 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 [ Time Frame: up to 12 weeks of clinical trial ]
    waist circumference was measured in centimeters.


Other Outcome Measures:
  1. Change in fasting concentrations of glucose [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483299


Locations
Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana

Responsible Party: Andrej Janez, professor, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02483299     History of Changes
Other Study ID Numbers: LIRA COMBI
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by Andrej Janez, University Medical Centre Ljubljana:
response to therapy

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists