Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-27 @ 10:07 PM
Study NCT ID:
NCT01341795
Status:
UNKNOWN
Last Update Posted:
2014-03-26
First Post:
2011-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Variation in the Transporters and Hypoglycemic Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-03-25', 'studyFirstSubmitDate': '2011-04-21', 'studyFirstSubmitQcDate': '2011-04-25', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'differences of sitagliptin and metformin trough concentration according to genetic variations of transporters', 'timeFrame': 'After 3 months of sitagliptin and metformin treatment'}], 'secondaryOutcomes': [{'measure': 'differences of HbA1c change according to genetic variations of transporters', 'timeFrame': 'Baseline and after 3 months of sitagliptin and metformin treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Newly diagnosed type 2 diabetes patients'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Type 2 diabetes have become a major global health problem. Currently, metformin is used as first-line therapy in combination with lifestyle changes, and sitagliptin can be added to metformin in case of insufficient glycemic control by metformin alone, and fixed-dose combination of sitagliptin and metformin is available.\n\nIn clinical practice, inter-individual variations in response to sitagliptin and metformin treatment are commonly found, which may reflect inter-patient differences in disposition of these medications.\n\nSitagliptin and metformin are known as substrates of some transporters (P-gp, OAT3, OCT1 and OCT2) and some functional variations of these transporters were reported. This study is designed to clarify the effect of these transporter variants on response to sitagliptin and metformin in type 2 DM patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly Diagnosed Type 2 Diabetes Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly Diagnosed Type 2 Diabetes Patients\n* 20-80 years old\n* Taking sitagliptin and metformin for more than 3 months\n\nExclusion Criteria:\n\n* Taking other oral hypoglycemic agents\n* Taking medications can induce or inhibit transporters'}, 'identificationModule': {'nctId': 'NCT01341795', 'briefTitle': 'Genetic Variation in the Transporters and Hypoglycemic Agents', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Effect of Genetic Variation in the Transporters on Glycemic Response and Pharmacokinetics of Sitagliptin and Metformin', 'orgStudyIdInfo': {'id': 'GDM01'}}, 'contactsLocationsModule': {'locations': [{'zip': '433-721', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Doo-Yeoun Cho, MD', 'role': 'CONTACT', 'email': 'dooycho@ajou.ac.kr', 'phone': '+82-31-219-4271'}, {'name': 'Young-Sang Kim, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ajou University School of Medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Doo-Yeoun Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assitant Professor', 'investigatorFullName': 'Doo-Yeoun Cho', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}