Back to resultsPolycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin
Primary Purpose
PCOS, Obesity
Status
Completed
Phase
Phase 4
Locations
Slovenia
Study Type
Interventional
Intervention
metformin
liraglutide
metformin and liraglutide
Sponsored by
About this trial
This is an interventional treatment trial for PCOS focused on measuring PCOS, obesity, GLP-1 receptor agonist, liraglutide, metformin
Eligibility Criteria
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
Sites / Locations
- University Medical Center Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
metformin
liraglutide
metformin and liraglutide
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
The main outcome was change in body weight.
Secondary Outcome Measures
The secondary outcome was 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.
The secondary outcome was change in waist circumference.
Patient's waist circumference was measured in centimeters.
Full Information
NCT ID
NCT01911468
First Posted
July 21, 2013
Last Updated
July 26, 2013
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT01911468
Brief Title
Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS, Obesity
Keywords
PCOS, obesity, GLP-1 receptor agonist, liraglutide, metformin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metformin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
liraglutide
Arm Type
Active Comparator
Arm Description
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.
Arm Title
metformin and liraglutide
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
Glucophage tablets
Intervention Type
Drug
Intervention Name(s)
liraglutide
Other Intervention Name(s)
Victoza 6 mg/ml solution for injection in pre-filled pen
Intervention Type
Drug
Intervention Name(s)
metformin and liraglutide
Other Intervention Name(s)
Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The secondary outcome was change in body mass index (BMI).
Description
Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.
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.
Title
The secondary outcome was change in waist circumference.
Description
Patient's waist circumference was measured in centimeters.
Time Frame
Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.
Other Pre-specified Outcome Measures:
Title
The other outcomes was changes changes in fasting concentrations of glucose.
Description
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.
Time Frame
Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.
Title
Other outcome was change in fasting concentration of insulin.
Description
Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.
Time Frame
Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.
Title
Other outcome was change in blood concentrations of LH (luteinizing hormone).
Description
Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L.
Time Frame
Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.
Title
Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone).
Description
Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L.
Time Frame
Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.
Title
Other outcome was change in blood concentration of testosterone.
Description
Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.
Time Frame
Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.
Title
Other outcome was change in blood concentration in androstenedione.
Description
Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L.
Time Frame
Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.
Title
Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).
Description
Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L.
Time Frame
Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.
Title
Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate).
Description
Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L.
Time Frame
Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Janez, MD PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25330463
Citation
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.
Results Reference
derived
Learn more about this trial
Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin
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