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

Sponsor
University Medical Centre Ljubljana
Study ID
NCT01911468
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 30, 2011
Status verified
Jul 2013
Primary completion
Oct 31, 2012
Completion
Apr 30, 2013

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

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. ]

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