Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-03-05 @ 1:54 AM
Study NCT ID:
NCT02844803
Status:
UNKNOWN
Last Update Posted:
2016-08-03
First Post:
2016-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2016-07-22', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of serum glucose level after 8 weeks from baseline', 'timeFrame': 'Day1 and Day 57 on the 1st and 2nd periods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The study is a pilot trial to investigate the effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed as a diabetes mellitus patient at least 3 months ago on screening\n* Treated with metformin of ≥ 500 mg/day over 3 months on screening\n* Fasting glucose level of 110\\~180 mg/dl or HbA1c of 7.0\\~9.0% on screening\n\nExclusion Criteria:\n\n* With acute or chronic inflammation\n* Treated with systemic corticosteroids within 4 weeks prior to the first administration of study medication\n* With heart failure, myocardial infarction, stroke, or other acute severe cardiovascular diseases\n* With acute or chronic renal failure or nephrotic syndrome\n* With impaired hepatic function.\n* Drug or Alcoholic abuser\n* Pregnant or nursing woman'}, 'identificationModule': {'nctId': 'NCT02844803', 'briefTitle': 'Study of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients', 'organization': {'class': 'OTHER', 'fullName': 'DongGuk University'}, 'officialTitle': 'Pilot Study to Investigate the Effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients', 'orgStudyIdInfo': {'id': 'S.baicalensis-Metformin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Active drug-> Placebo', 'description': 'Metformin + S. Baicalensis --\\> Metformin + Placebo', 'interventionNames': ['Drug: Combination of Metformin + S. Baicalensis', 'Drug: Combination of Metformin + Placebo']}, {'type': 'OTHER', 'label': 'Placebo -> Active drug', 'description': 'Metformin + Placebo --\\> Metformin + S. Baicalensis', 'interventionNames': ['Drug: Combination of Metformin + S. Baicalensis', 'Drug: Combination of Metformin + Placebo']}], 'interventions': [{'name': 'Combination of Metformin + S. Baicalensis', 'type': 'DRUG', 'description': 'the combination therapy for 8 weeks', 'armGroupLabels': ['Active drug-> Placebo', 'Placebo -> Active drug']}, {'name': 'Combination of Metformin + Placebo', 'type': 'DRUG', 'description': 'the metformin single therapy for 8 weeks', 'armGroupLabels': ['Active drug-> Placebo', 'Placebo -> Active drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-773', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Namyi Gu, MD, PhD', 'role': 'CONTACT', 'email': 'namyi.gu@gmail.com', 'phone': '+82-31-961-8440'}], 'facility': 'Dongguk University Ilsan Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'centralContacts': [{'name': 'Namyi Gu, MD, PhD', 'role': 'CONTACT', 'email': 'namyi.gu@gmail.com', 'phone': '+82-31-961-8440'}, {'name': 'Han Seok Choi, MD, PhD', 'role': 'CONTACT', 'email': 'hschoi402@dumc.or.kr', 'phone': '+82-31-961-5777'}], 'overallOfficials': [{'name': 'Han Seok Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dongguk University College of Medicine and Ilsan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Namyi Gu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Namyi Gu', 'investigatorAffiliation': 'DongGuk University'}}}}