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

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: PCOS; Obesity

Treatments: Drug: metformin and liraglutide; Drug: liraglutide; Drug: metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01911468

20120047-LIRA1

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

metformin

Active Comparator group

Description:

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.

Treatment:

Drug: metformin

liraglutide

Active Comparator group

Description:

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.

Treatment:

Drug: liraglutide

metformin and liraglutide

Active Comparator group

Description:

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.

Treatment:

Drug: metformin and liraglutide