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

NCT02483299 | Completed Phase 4

• 1 other identifier: LIRA COMBI
• Study Type: interventional
• Target: 40
• 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 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.

Conditions

PCOS; Obesity

Keywords

response to therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in body mass index (BMI).

  up to 12 weeks of clinical trial

• Change in waist circumference

  up to 12 weeks of clinical trial

Other Outcomes (8)

• Change in fasting concentrations of glucose

  up to 12 weeks of clinical trial

• Change in fasting concentration of insulin

  up to 12 weeks of clinical trial

• Change in blood concentrations of LH (luteinizing hormone)

  up to 12 weeks of clinical trial

Study Arms (2)

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

combined

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: Glucophage tablets and Victoza

Interventions

Metformin DRUG

Also known as: Glucophage tablets

metformin

Glucophage tablets and Victoza DRUG

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

combined

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

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 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: June 24, 2015
• First Posted: June 26, 2015
• Study Start: January 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

SL (1)