Polycystic Ovary Syndrome and Liraglutide

NCT01899430 | Completed Phase 4

• 1 other identifier: 20120047
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to determine whether liraglutide is more effective than metformin in the treatment of obese women with newly diagnosed polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients treated with liraglutide than in those treated with metformin.

Conditions

PCOS; Obesity

Keywords

PCOS; obesity; GLP-1 receptor agonist; liraglutide; metformin

Outcome Measures

Primary Outcomes (1)

• The main outcome was change in body weight.

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

Secondary Outcomes (2)

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

  Patient's body weight were measured at the base point and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint.

• The secondary outcome was change in waist circumference.

  Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.

Other Outcomes (8)

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

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

• Other outcome was change in fasting concentration of insulin.

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

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

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

Study Arms (2)

metformin

ACTIVE COMPARATOR

In the MET 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

liraglutide

EXPERIMENTAL

In the LIRA 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.

Drug: liraglutide

Interventions

liraglutide DRUG

Also known as: Victoza 6 mg/ml solution for injection in pre-filled pen

liraglutide

metformin DRUG

Also known as: Glucophage tablets

metformin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old to menopause
• polycystic ovary syndrome (NICHD criteria)
• BMI of 30 kg/m² or higher

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide; Solutions; Injections; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Andrej Janez, MD, PhD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, MD, PhD

Study Record Dates

• First Submitted: July 7, 2013
• First Posted: July 15, 2013
• Study Start: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2013
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

SL (1)