Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-28 @ 10:15 PM
Study NCT ID:
NCT01911468
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2013-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-26', 'studyFirstSubmitDate': '2013-07-21', 'studyFirstSubmitQcDate': '2013-07-26', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The other outcomes was changes changes in fasting concentrations of glucose.', 'timeFrame': "Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.", 'description': "Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L."}, {'measure': 'Other outcome was change in fasting concentration of insulin.', 'timeFrame': "Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.", 'description': "Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L."}, {'measure': 'Other outcome was change in blood concentrations of LH (luteinizing hormone).', 'timeFrame': "Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.", 'description': "Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L."}, {'measure': 'Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone).', 'timeFrame': "Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.", 'description': "Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L."}, {'measure': 'Other outcome was change in blood concentration of testosterone.', 'timeFrame': "Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.", 'description': "Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L."}, {'measure': 'Other outcome was change in blood concentration in androstenedione.', 'timeFrame': "Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.", 'description': "Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L."}, {'measure': 'Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).', 'timeFrame': "Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.", 'description': "Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L."}, {'measure': 'Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate).', 'timeFrame': "Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.", 'description': "Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L."}], 'primaryOutcomes': [{'measure': 'The main outcome was change in body weight.', 'timeFrame': "Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial."}], 'secondaryOutcomes': [{'measure': 'The secondary outcome was change in body mass index (BMI).', 'timeFrame': "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.", 'description': "Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters."}, {'measure': 'The secondary outcome was change in waist circumference.', 'timeFrame': "Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.", 'description': "Patient's waist circumference was measured in centimeters."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCOS', 'obesity', 'GLP-1 receptor agonist', 'liraglutide', 'metformin'], 'conditions': ['PCOS', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '25330463', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years old to menopause\n* polycystic ovary syndrome (NICHD criteria)\n* BMI of 30 kg/m² or higher\n* poor response to previous treatment with metformin for at least 3 months\n\nExclusion Criteria:\n\n* type 1 or type 2 diabetes mellitus\n* history of carcinoma\n* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia\n* personal or family history of MEN 2\n* significant cardiovascular, kidney or hepatic disease\n* the use of medications known or suspected to affect reproductive or metabolic functions\n* the use of statins, within 90 days prior to study entry"}, 'identificationModule': {'nctId': 'NCT01911468', 'briefTitle': 'Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '20120047-LIRA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'metformin', '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.', 'interventionNames': ['Drug: metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'liraglutide', '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.', 'interventionNames': ['Drug: liraglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'metformin and liraglutide', '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.', 'interventionNames': ['Drug: metformin and liraglutide']}], 'interventions': [{'name': 'metformin', 'type': 'DRUG', 'otherNames': ['Glucophage tablets'], 'armGroupLabels': ['metformin']}, {'name': 'liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza 6 mg/ml solution for injection in pre-filled pen'], 'armGroupLabels': ['liraglutide']}, {'name': 'metformin and liraglutide', 'type': 'DRUG', 'otherNames': ['Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen'], 'armGroupLabels': ['metformin and liraglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Center Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Andrej Janez, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Ljubljana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor, MD, PhD', 'investigatorFullName': 'Andrej Janez', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}