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

NCT ID: NCT02483299

Last Updated: 2015-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

PCOS; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

combined

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.

Group Type: ACTIVE_COMPARATOR

Glucophage tablets and Victoza

Intervention Type: DRUG

Interventions

Metformin

Intervention Type: DRUG

Glucophage tablets and Victoza

Intervention Type: DRUG

Other Intervention Names

Glucophage tablets; Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Andrej Janez

professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Center Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

LIRA COMBI

Identifier Type: -

Identifier Source: org_study_id