Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-02 @ 7:23 AM
Study NCT ID:
NCT02123732
Status:
UNKNOWN
Last Update Posted:
2017-03-07
First Post:
2014-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 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'}], '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'lastUpdateSubmitDate': '2017-03-05', 'studyFirstSubmitDate': '2014-04-02', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1C concentrations and fasting glucose levels', 'timeFrame': '6 months from last patient in'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Diabetes Mellitus', 'Herbal', 'food supplement'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a 2-arm, single-blind, crossover, placebo-controlled clinical study, with 24 weeks of therapy to evaluate the efficacy and safety of DbXell in improving metabolic control in patients with Type 2 Diabetes that is mildly uncontrolled, defined as HbA1c above target but less than 8.0% on their current conventional therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects with age of 18-70 years Established type 2 diabetes mellitus as defined by the American Diabetes Association, but of duration less than 10 years.\n* Suboptimal glycemic control as judged by HbA1c over target but not more than 8.0%.Current medication of not more than 2 oral hypoglycemic agents. No current or past insulin or GLP1 therapy.\n* FPG ≤ 180 mg/dL\n* Hemoglobin level of ≥ 10.0 g/dL\n* Serum ALT ≤ 2.5 times upper limit of normal\n* Serum creatinine \\< 1.5 times upper limit of normal\n\nExclusion Criteria:\n\n* Female of childbearing potential\n* Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment\n* Uncontrolled hypertension (SBP \\> 160 mmHg and/or DBP \\> 100 mmHg)\n* History of renal and/or liver disease\n* History of or the presence of any clinical evidence of malignancies\n* Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections\n* Current treatment with systemic corticosteroids or herbal (alternative) medicines\n* Participation in any other intervention trial within 30 days prior to Screening'}, 'identificationModule': {'nctId': 'NCT02123732', 'briefTitle': 'Role of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Laniado Hospital'}, 'officialTitle': 'Role of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'DbXell1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DbXell', 'description': "Drug: DbXell three times daily for 12 weeks and then switching to Placebo of DbXell for 12 additional months Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.", 'interventionNames': ['Dietary Supplement: DbXell']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "Drug: Placebo of DbXell Placebo of DbXell three times daily for 12 weeks and then switching to DbXell for 12 additional weeks Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.", 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'DbXell', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['DbXell']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42150', 'city': 'Netanya', 'country': 'Israel', 'facility': 'Laniado Hospital, Diabetes Unit', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'overallOfficials': [{'name': 'Mark J Niven, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laniado Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laniado Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'KGS Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Mark J NIVEN Director of Endocrine and Diabetes Unit', 'investigatorFullName': 'Laniado Hospital', 'investigatorAffiliation': 'Laniado Hospital'}}}}