Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-01 @ 6:02 PM
Study NCT ID:
NCT02628392
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2015-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629701', 'term': 'firuglipel'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 368}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2015-12-09', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in HbA1c', 'timeFrame': 'baseline (Day -1) to Week 12', 'description': 'HbA1c = glycated hemoglobin'}], 'secondaryOutcomes': [{'measure': 'change in HbA1c', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in HbA1c', 'timeFrame': 'baseline (Day -1) to Week 8'}, {'measure': 'proportion of subjects with HbA1c <7.0', 'timeFrame': 'baseline (Day -1) to Week 12', 'description': 'proportion of subjects who achieve HbA1c \\<7.0'}, {'measure': 'change in plasma glucose', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in plasma glucose', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in AUC derived from plasma glucose', 'timeFrame': 'baseline (Day -1) to Week 4', 'description': 'change in pharmacodynamics profile consists of Area Under Curve (AUC), Concentration maximum (Cmax), Time of maximum concentration (Tmax)'}, {'measure': 'change in AUC derived from plasma glucose', 'timeFrame': 'baseline (Day -1) to Week 12', 'description': 'pharmacodynamics profile consists of AUC, Cmax, Tmax'}, {'measure': 'change in serum insulin', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in AUC 0-3h serum insulin', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in serum insulin', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in AUC 0-3h serum insulin', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in proinsulin', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in AUC 0-3h proinsulin', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in proinsulin', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in AUC 0-3h proinsulin', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in C-peptide', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in AUC 0-3h C-peptide', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in C-peptide', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in AUC 0-3h C-peptide', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in PYY', 'timeFrame': 'baseline (Day -1) to Week 4', 'description': 'PYY = peptide YY'}, {'measure': 'change in AUC 0-3h PYY', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in PYY', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in AUC 0-3h PYY', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in total GLP-1', 'timeFrame': 'baseline (Day -1) to Week 4', 'description': 'GLP-1 = Glucagon-Like Peptide-1'}, {'measure': 'change in total AUC 0-3h GLP-1', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in total GLP-1', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in AUC 0-3h total GLP-1', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in active GLP-1', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in AUC 0-3h active GLP-1', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in active GLP-1', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in AUC 0-3h active GLP-1', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in total GIP', 'timeFrame': 'baseline (Day -1) to Week 4', 'description': 'GIP = Gastric Inhibitory Polypeptide'}, {'measure': 'change in AUC 0-3h total GIP', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in total GIP', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in AUC 0-3h total GIP', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in glucagon', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in AUC 0-3h glucagon', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in glucagon', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in AUC 0-3h glucagon', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in 1,5 AG', 'timeFrame': 'baseline (Day -1) to Week 4', 'description': '1,5 AG = 1,5 anhydrogucitol'}, {'measure': 'change in AUC 0-3h 1,5 AG', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in 1,5 AG', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in AUC 0-3h 1,5 AG', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in total cholesterol', 'timeFrame': 'baseline (Day -1) to Week 2'}, {'measure': 'change in total cholesterol', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in total cholesterol', 'timeFrame': 'baseline (Day -1) to Week 8'}, {'measure': 'change in total cholesterol', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in HDL cholesterol', 'timeFrame': 'baseline (Day -1) to Week 2', 'description': 'HDL = high density lipoprotein'}, {'measure': 'change in HDL cholesterol', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in HDL cholesterol', 'timeFrame': 'baseline (Day -1) to Week 8'}, {'measure': 'change in HDL cholesterol', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in LDL cholesterol', 'timeFrame': 'baseline (Day -1) to Week 2', 'description': 'LDL = low density lipoprotein'}, {'measure': 'change in LDL cholesterol', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in LDL cholesterol', 'timeFrame': 'baseline (Day -1) to Week 8'}, {'measure': 'change in LDL cholesterol', 'timeFrame': 'baseline (Day -1) to Week 12'}, {'measure': 'change in triglyceride', 'timeFrame': 'baseline (Day -1) to Week 2'}, {'measure': 'change in triglyceride', 'timeFrame': 'baseline (Day -1) to Week 4'}, {'measure': 'change in triglyceride', 'timeFrame': 'baseline (Day -1) to Week 8'}, {'measure': 'change in triglyceride', 'timeFrame': 'baseline (Day -1) to Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Adult', 'Developmental Phase II'], 'conditions': ['Type2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus.', 'detailedDescription': 'The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus after a 12-week oral administration of DS-8500a at 25, 50, or 75 mg in a double-blind, parallel-group comparison study. In addition, the clinical positioning of DS-8500a relative to an existing drug will be investigated using sitagliptin as a comparator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥ 20 years at the time of informed consent\n* Japanese patients with type 2 diabetes\n* Patients who have HbA1c ≥ 7.0% and \\< 10.0%\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis\n* Patients receiving or requiring treatment with insulin\n* Patients with a body mass index (BMI) of \\< 18.5 kg/m2 or ≥ 35.0 kg/m2\n* Patients with clinically evident renal impairment (estimated glomerular filtration rate \\[eGFR\\] of \\< 45 mL/min per 1.73 m2) or clinically significant renal disease\n* Patients with fasting plasma glucose ≥ 240 mg/dL'}, 'identificationModule': {'nctId': 'NCT02628392', 'briefTitle': 'A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Dose Finding Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'DS8500-A-J203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DS-8500a 25 mg QD', 'description': 'DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule', 'interventionNames': ['Drug: DS-8500a', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DS-8500a 50 mg QD', 'description': 'DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule', 'interventionNames': ['Drug: DS-8500a', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DS-8500a 75 mg QD', 'description': 'DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule', 'interventionNames': ['Drug: DS-8500a', 'Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively.', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin', 'description': 'capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet', 'interventionNames': ['Drug: Sitagliptin', 'Drug: placebo']}], 'interventions': [{'name': 'DS-8500a', 'type': 'DRUG', 'description': 'DS-8500a tablets 25mg, 50mg, 75mg', 'armGroupLabels': ['DS-8500a 25 mg QD', 'DS-8500a 50 mg QD', 'DS-8500a 75 mg QD']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': 'capsules', 'armGroupLabels': ['Sitagliptin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'matching DS-8500a tablets and sitagliptin capsules', 'armGroupLabels': ['DS-8500a 25 mg QD', 'DS-8500a 50 mg QD', 'DS-8500a 75 mg QD', 'Sitagliptin', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Heishinkai Medical Group Incorporated OCROM Clinic'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}