Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT01005069
Status:
COMPLETED
Last Update Posted:
2010-09-28
First Post:
2009-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-26', 'studyFirstSubmitDate': '2009-10-28', 'studyFirstSubmitQcDate': '2009-10-29', 'lastUpdatePostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of venous Fasting Plasma Glucose from baseline', 'timeFrame': 'every 2-week interval over 6 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Reduction of 2h-post-prandial plasma glucose from baseline', 'timeFrame': 'six weeks'}, {'measure': 'Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline', 'timeFrame': 'six weeks'}, {'measure': 'Change of high sensitivity C-reactive protein (hs-CRP) from baseline', 'timeFrame': 'six weeks'}, {'measure': 'Liver Function, Renal Function, Adverse events', 'timeFrame': 'six weeks'}, {'measure': 'Change in HbA1c from baseline', 'timeFrame': 'six weeks'}, {'measure': 'Change in lipid profile from baseline', 'timeFrame': 'six weeks'}]}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'DLBS-32', 'fasting plasma glucose', 'insulin resistance'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting capillary blood glucose of 127-249 mg/dL at screening\n* BMI \\>= 18.5 kg/m\\^2 or waist circumference of \\>= 90 cm (male) or \\>= 80 cm (female)\n* Normal liver function\n* Normal renal function\n* OHA-naive type-II-diabetic patients\n\nExclusion Criteria:\n\n* Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia\n* Uncontrolled hypertension\n* History of or current treatment with insulin\n* Current treatment with systemic corticosteroids or herbal (alternative) medicines\n* History of renal and/or liver disease\n* Pregnant or breast feeding females'}, 'identificationModule': {'nctId': 'NCT01005069', 'briefTitle': 'Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dexa Medica Group'}, 'officialTitle': 'Phase-II Clinical Study: A Randomized, Double Blind, Dose Ranging, and Controlled Study to Evaluate the Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'DLBS-32-0309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment I', 'interventionNames': ['Drug: DLBS-32']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment II', 'interventionNames': ['Drug: DLBS-32']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment III', 'interventionNames': ['Drug: DLBS-32']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment IV', 'interventionNames': ['Drug: DLBS-32']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo capsule']}], 'interventions': [{'name': 'DLBS-32', 'type': 'DRUG', 'description': 'DLBS-32 50 mg once daily and lifestyle modification', 'armGroupLabels': ['Treatment I']}, {'name': 'DLBS-32', 'type': 'DRUG', 'description': 'DLBS-32 100 mg once daily and lifestyle modification', 'armGroupLabels': ['Treatment II']}, {'name': 'DLBS-32', 'type': 'DRUG', 'description': 'DLBS-32 200 mg once daily and lifestyle modification', 'armGroupLabels': ['Treatment III']}, {'name': 'DLBS-32', 'type': 'DRUG', 'description': 'DLBS-32 300 mg once daily and lifestyle modification', 'armGroupLabels': ['Treatment IV']}, {'name': 'Placebo capsule', 'type': 'DRUG', 'description': 'Placebo capsules once daily and lifestyle modification', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denpasar', 'state': 'Bali', 'country': 'Indonesia', 'facility': 'Sanglah Hospital Denpasar', 'geoPoint': {'lat': -8.65, 'lon': 115.21667}}, {'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'RSUD Tarakan', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Ketut Suastika, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Endocrinology and Metabolic Disease University of Udayana / Sanglah Denpasar Hospital'}, {'name': 'Nuniek E Nugrahini, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of internal medicine, RSUD Tarakan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dexa Medica Group', 'class': 'INDUSTRY'}}}}