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

NCT01911468 | Completed Phase 4

• 1 other identifier: 20120047-LIRA1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

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 basepoint 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 (3)

metformin

ACTIVE COMPARATOR

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

liraglutide

ACTIVE COMPARATOR

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.

Drug: liraglutide

metformin and liraglutide

ACTIVE COMPARATOR

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: metformin and liraglutide

Interventions

metformin DRUG

Also known as: Glucophage tablets

metformin

liraglutide DRUG

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

liraglutide

metformin and liraglutide DRUG

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

metformin and liraglutide

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
• poor response to previous treatment with metformin for at least 3 months

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

Related Publications (1)

• 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.

  PMID: 25330463 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Metformin; Liraglutide; Solutions; Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; 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

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 21, 2013
• First Posted: July 30, 2013
• Study Start: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

SL (1)