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Completed

NCT Number: NCT01911468

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

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.

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Key information

Conditions

PCOS Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Other names: Glucophage tablets

liraglutide

Drug

Other names: Victoza 6 mg/ml solution for injection in pre-filled pen

metformin and liraglutide

Drug

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

Primary outcomes

  1. The main outcome was change in body weight.

    Time frame: Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.

Secondary outcomes

  1. The secondary outcome was change in body mass index (BMI).

    Time frame: 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.

  2. The secondary outcome was change in waist circumference.

    Time frame: 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.

Other outcomes

  1. The other outcomes was changes changes in fasting concentrations of glucose.

    Time frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.

    Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.

  2. Other outcome was change in fasting concentration of insulin.

    Time frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.

    Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.

  3. Other outcome was change in blood concentrations of LH (luteinizing hormone).

    Time frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.

    Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L.

  4. Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone).

    Time frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.

    Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L.

  5. Other outcome was change in blood concentration of testosterone.

    Time frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.

    Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.

  6. Other outcome was change in blood concentration in androstenedione.

    Time frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.

    Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L.

  7. Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).

    Time frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.

    Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L.

  8. Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate).

    Time frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.

    Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Short-term Combined Treatment With Liraglutide and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome and Previous Poor Response to Metformin

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 30, 2013
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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