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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; PCOS
• Intervention / Treatment: Drug: Metformin; Drug: Glucophage tablets and Victoza

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Center Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: Metformin; Other Names: Glucophage tablets
ACTIVE_COMPARATOR: 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.	Drug: Glucophage tablets and Victoza; Other Names: Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in body weight	up to 12 weeks of clinical trial
The number of good responders to combined treatment regarding body weight	up to 12 weeks of clinical trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass index (BMI).	Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.	up to 12 weeks of clinical trial
Change in waist circumference	waist circumference was measured in centimeters.	up to 12 weeks of clinical trial

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting concentrations of glucose	Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.	up to 12 weeks of clinical trial
Change in fasting concentration of insulin	Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.	up to 12 weeks of clinical trial
Change in blood concentrations of LH (luteinizing hormone)	Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L.	up to 12 weeks of clinical trial
Change in blood concentrations of FSH (follicle-stimulating hormone)	Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L.	up to 12 weeks of clinical trial
Change in blood concentration of testosterone	Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.	up to 12 weeks of clinical trial
Change in blood concentration in androstenedione	Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L.	up to 12 weeks of clinical trial
Change in blood concentrations of SHBG (sex hormone-binding globulin)	Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L.	up to 12 weeks of clinical trial
Change in blood concentration of DHEAS (dehydroepiandrosterone sulfate)	Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L.	up to 12 weeks of clinical trial

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (ESTIMATE): June 26, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): June 26, 2015
• Last Update Submitted That Met QC Criteria: June 25, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: response to therapy
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide; Metformin
• Other Study ID Numbers: LIRA COMBI