Short-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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- The main outcome was change in body weight.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: metformin (Drug)
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.
Intervention: liraglutide (Drug)
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.
Intervention: metformin and liraglutide (Drug)
Outcomes
Primary Outcomes
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
- The secondary outcome was change in body mass index (BMI).(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.)
- The secondary outcome was change in waist circumference.(Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.)
Investigators
Andrej Janez
professor, MD, PhD
University Medical Centre Ljubljana