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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionPCOS
Obesity
InterventionDrug: metformin
Drug: liraglutide
Drug: metformin and liraglutide
PhasePhase 4
SponsorUniversity Medical Centre Ljubljana
Responsible PartyUniversity Medical Centre Ljubljana
ClinicalTrials.gov IdentifierNCT01911468
First ReceivedJuly 21, 2013
Last UpdatedJuly 26, 2013
Last verifiedJuly 2013

Tracking Information[ + expand ][ + ]

First Received DateJuly 21, 2013
Last Updated DateJuly 26, 2013
Start DateNovember 2011
Estimated Primary Completion DateApril 2013
Current Primary Outcome MeasuresThe 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.] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • 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.] [Designated as safety issue: No]Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.
  • 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.] [Designated as safety issue: No]Patient's waist circumference was measured in centimeters.

Descriptive Information[ + expand ][ + ]

Brief TitlePolycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin
Official TitleShort-term Combined Treatment With Liraglutide and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome and Previous Poor Response to Metformin
Brief Summary
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • PCOS
  • Obesity
InterventionDrug: metformin
Other Names:
Glucophage tabletsDrug: liraglutide
Other Names:
Victoza 6 mg/ml solution for injection in pre-filled penDrug: metformin and liraglutide
Other Names:
Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen
Study Arm (s)
  • 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment36
Estimated Completion DateApril 2013
Estimated Primary Completion DateOctober 2012
Eligibility Criteria
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
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesSlovenia

Administrative Information[ + expand ][ + ]

NCT Number NCT01911468
Other Study ID Numbers20120047-LIRA1
Has Data Monitoring CommitteeNo
Information Provided ByUniversity Medical Centre Ljubljana
Study SponsorUniversity Medical Centre Ljubljana
CollaboratorsNot Provided
Investigators Principal Investigator: Andrej Janez, MD PhD University Medical Centre Ljubljana
Verification DateJuly 2013

Locations[ + expand ][ + ]

University Medical Center Ljubljana
Ljubljana, Slovenia, 1000