Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-02 @ 1:08 AM
Study NCT ID:
NCT01333592
Status:
COMPLETED
Last Update Posted:
2014-12-15
First Post:
2011-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Study of KAD-1229 in Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C087255', 'term': 'mitiglinide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rinsyousiken@pharm.kissei.co.jp', 'title': 'Clinical Development Division', 'organization': 'Kissei Pharmaceutical Co., Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'KAD-1229 / DPP-4 Inhibitors', 'otherNumAtRisk': 67, 'otherNumAffected': 34, 'seriousNumAtRisk': 67, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'KAD-1229 / Biguanides', 'otherNumAtRisk': 69, 'otherNumAffected': 47, 'seriousNumAtRisk': 69, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 8}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 30}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Alanine aminotransferase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'γ-glutamyltransferase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 7}], 'organSystem': 'Investigations'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'White blood cell count increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 5}], 'organSystem': 'Investigations'}], 'seriousEvents': [{'term': 'large intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'traumatic lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KAD-1229 / DPP-4 Inhibitors'}, {'id': 'OG001', 'title': 'KAD-1229 / Biguanides'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at week 0 and week 52', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidences of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KAD-1229 / DPP-4 Inhibitors'}, {'id': 'OG001', 'title': 'KAD-1229 / Biguanides'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'KAD-1229 / DPP-4 Inhibitors'}, {'id': 'FG001', 'title': 'KAD-1229 / Biguanides'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'KAD-1229 / DPP-4 Inhibitors'}, {'id': 'BG001', 'title': 'KAD-1229 / Biguanides'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '58.6', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.47', 'spread': '0.54', 'groupId': 'BG000'}, {'value': '7.50', 'spread': '0.66', 'groupId': 'BG001'}, {'value': '7.49', 'spread': '0.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'One patient in the KAD-1229 / biguanides group was excluded because of early discontinuation and no evaluable HbA1c.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-27', 'studyFirstSubmitDate': '2011-04-06', 'resultsFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2011-04-10', 'lastUpdatePostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-17', 'studyFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidences of Adverse Events', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at 52 Weeks', 'timeFrame': 'at week 0 and week 52'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'HbA1c', 'Long-term study'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy\n* Age in the 20 years or over inclusive\n* HbA1c in the range of ≥ 6.5 to \\< 9%\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Patients with serious diabetic complications and other serious complications'}, 'identificationModule': {'nctId': 'NCT01333592', 'briefTitle': 'Long-term Study of KAD-1229 in Type 2 Diabetes Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Open Label, Long-term Study of KAD-1229 in Type 2 Diabetes Patients Who Show Inadequate Glycemic Control With Diet, and Biguanide or DPP-4 Inhibitor Monotherapy', 'orgStudyIdInfo': {'id': 'KAD4301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KAD-1229', 'interventionNames': ['Drug: KAD-1229']}], 'interventions': [{'name': 'KAD-1229', 'type': 'DRUG', 'armGroupLabels': ['KAD-1229']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kanto Region, Chugoku Region, Kyushu Region', 'country': 'Japan', 'facility': 'Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}}}}