Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-04-17 @ 3:08 AM
Study NCT ID:
NCT02909933
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2016-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'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': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-16', 'studyFirstSubmitDate': '2016-09-13', 'studyFirstSubmitQcDate': '2016-09-16', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main outcome was change in body weight.', 'timeFrame': "Patient's body weight was measured at the base point and after 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 base point and after 12 weeks of clinical trial. Patient's height was measured at the base point."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '28143456', 'type': 'DERIVED', 'citation': 'Jensterle M, Kravos NA, Goricar K, Janez A. Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial. BMC Endocr Disord. 2017 Jan 31;17(1):5. doi: 10.1186/s12902-017-0155-9.'}]}, 'descriptionModule': {'briefSummary': 'Weight reduction is the most important treatment target when polycystic ovary syndrome (PCOS) is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide.\n\nWe investigates short term interventions with low dose liraglutide in combination with metformin and high dose liraglutide alone influence on significant weight reduction in obese women with PCOS.'}, '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\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': 'NCT02909933', 'briefTitle': 'Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'orgStudyIdInfo': {'id': 'COMBO - LIRA 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'liraglutide', 'description': 'liraglutide 3 mg QD for 12 weeks', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'metformin and liraglutide', 'description': 'metformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks', 'interventionNames': ['Drug: metformin and liraglutide']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza'], 'armGroupLabels': ['liraglutide']}, {'name': 'metformin and liraglutide', 'type': 'DRUG', 'otherNames': ['Glucophage and Victoza'], '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Andrej Janez', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}