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

Phase 4

Completed

• Conditions: PCOS; Obesity
• Interventions: Drug: Glucophage tablets and Victoza; Drug: Metformin

• Registration Number: NCT02483299
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-06
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-25
• Last Update Submitted: 2015-06-25
• Study First Posted: 2015-06-26
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined	Glucophage tablets and Victoza	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.
metformin	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.

Primary Outcome Measures

Name	Time	Method
The number of good responders to combined treatment regarding body weight	up to 12 weeks of clinical trial
Change in body weight	up to 12 weeks of clinical trial

Secondary Outcome Measures

Name	Time	Method
Change in body mass index (BMI).	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.
Change in waist circumference	up to 12 weeks of clinical trial	waist circumference was measured in centimeters.

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia