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

NCT ID: NCT01911468

Last Updated: 2013-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-04-30

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.

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

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.

Group Type: ACTIVE_COMPARATOR

liraglutide

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

metformin and liraglutide

Intervention Type: DRUG

Interventions

metformin

Intervention Type: DRUG

liraglutide

Intervention Type: DRUG

metformin and liraglutide

Intervention Type: DRUG

Other Intervention Names

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

• 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

Principal Investigators

Andrej Janez, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

University Medical Center Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

References

Jensterle M, Kocjan T, Kravos NA, Pfeifer M, Janez A. Short-term intervention with liraglutide improved eating behavior in obese women with polycystic ovary syndrome. Endocr Res. 2015;40(3):133-8. doi: 10.3109/07435800.2014.966385. Epub 2014 Oct 20.

Reference Type: DERIVED

PMID: 25330463 (View on PubMed)

Other Identifiers

20120047-LIRA1

Identifier Type: -

Identifier Source: org_study_id