Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-25 @ 2:04 PM
Study NCT ID:
NCT00994266
Status:
COMPLETED
Last Update Posted:
2011-04-29
First Post:
2009-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-27', 'studyFirstSubmitDate': '2009-10-13', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of insulin daily doses at week 24 and at the beginning of the study', 'timeFrame': '24 weeks'}, {'measure': 'Difference of glucose concentrations (fasting and post-prandial) at week 24 and at the beginning of the study considering the adjusted insulin doses during treatment', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Occurrence of hypoglycemic episodes during treatment', 'timeFrame': '24 weeks'}, {'measure': 'Difference of HbA1c concentrations at week 24 and at the beginning of the study', 'timeFrame': '24 weeks'}, {'measure': 'Difference of triglycerides and cholesterol concentrations at week 24 and at the beginning of the study', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'Diamel', 'Dietary supplement'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of Diamel (dietary supplement) administration in the treatment of patients with type 2 diabetes receiving insulin therapy. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of patients to be recruited and randomized for the study is 116. Daily insulin requirements, blood glucose (fasting and post-prandial) concentrations, glycosylated hemoglobin (HbA1c), triglycerides and cholesterol will be assessed at the beginning and after 24 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes with insulin therapy regimen of two daily doses.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Type 1 diabetes.\n* Type 2 diabetes with glibenclamide treatment.\n* Nephropathy or liver condition diagnosed by clinical and/or biochemical examination.\n* Sepsis.\n* Pregnancy.\n* HbA1c values greater than 10%.'}, 'identificationModule': {'nctId': 'NCT00994266', 'briefTitle': 'Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catalysis SL'}, 'officialTitle': 'Efficacy of Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy', 'orgStudyIdInfo': {'id': 'CAT-0912-CU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Diamel', 'interventionNames': ['Dietary Supplement: Diamel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Diamel', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks, in combination with the standard treatment consisting in two daily doses of insulin and proper diet.', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks, in combination with the standard treatment consisting in two daily doses of insulin and proper diet.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20200', 'city': 'Pinar del Río', 'state': 'Provincia de Pinar del Río', 'country': 'Cuba', 'facility': 'Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital', 'geoPoint': {'lat': 22.41649, 'lon': -83.69657}}], 'overallOfficials': [{'name': 'Maria Elena de la Uz Herrera, MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Abel Santamaría Cuadrado" General Hospital'}, {'name': 'Arturo Hernández Yero, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Endocrinology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalysis SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Maria Elena de la Uz Herrera', 'oldOrganization': '"Abel Santamaría Cuadrado"General Hospital'}}}}