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

Study Overview
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Brief Summary
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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.

Conditions
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PCOS, Obesity

Intervention / Treatment
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* Drug: Metformin
* Drug: Glucophage tablets and Victoza


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin<br>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<br> <br> * Other names: Glucophage tablets;|
| Active Comparator: combined<br>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<br> <br> * Other names: Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | up to 12 weeks of clinical trial | 
| The number of good responders to combined treatment regarding body weight |  | up to 12 weeks of clinical trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index (BMI). | Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters. | up to 12 weeks of clinical trial | 
| Change in waist circumference | waist circumference was measured in centimeters. | up to 12 weeks of clinical trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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response to therapy