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

Phase 4

Completed

• Conditions: PCOS; Obesity
• Interventions: Drug: metformin and liraglutide; Drug: metformin; Drug: liraglutide

• Registration Number: NCT01911468
• 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 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 Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-10
• Study Completion: 2013-04
• Status Verified: 2013-07
• Study First Submitted: 2013-07-21
• Study First Submitted QC: 2013-07-26
• Last Update Submitted: 2013-07-26
• Study First Posted: 2013-07-30
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin and liraglutide	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.
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.
liraglutide	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.

Primary Outcome Measures

Name	Time	Method
The main outcome was change in body weight.	Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.

Secondary Outcome Measures

Name	Time	Method
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.	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.	Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.	Patient's waist circumference was measured in centimeters.

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia