Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-25 @ 1:01 AM
Study NCT ID:
NCT02537834
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2015-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tofogliflozin GLP-1 Analogue Combination Trial
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': 'C575086', 'term': "6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-15', 'studyFirstSubmitDate': '2015-08-25', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction', 'timeFrame': 'baseline and Week 52'}, {'measure': 'Change from Baseline in HbA1c at 52 weeks', 'timeFrame': 'Week 52'}], 'secondaryOutcomes': [{'measure': 'Change in Fasting plasma glucose', 'timeFrame': 'baseline and week 52'}, {'measure': 'Change in Body Weight', 'timeFrame': 'baseline and week 52'}, {'measure': 'Change in Blood pressure', 'timeFrame': 'baseline and week 52'}, {'measure': 'Change in Uric Acid', 'timeFrame': 'baseline and week 52'}, {'measure': 'Change in Total cholesterol', 'timeFrame': 'baseline and week 52'}, {'measure': 'Change in HDL-C', 'timeFrame': 'baseline and week 52'}, {'measure': 'Change in LDL-C', 'timeFrame': 'baseline and week 52'}, {'measure': 'Change in non HDL-C', 'timeFrame': 'baseline and week 52'}, {'measure': 'Change in Free Fatty Acid', 'timeFrame': 'baseline and week 52'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '31033218', 'type': 'RESULT', 'citation': 'Terauchi Y, Fujiwara H, Kurihara Y, Suganami H, Tamura M, Senda M, Gunji R, Kaku K. Long-term safety and efficacy of the sodium-glucose cotransporter 2 inhibitor, tofogliflozin, added on glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week open-label, multicenter, post-marketing clinical study. J Diabetes Investig. 2019 Nov;10(6):1518-1526. doi: 10.1111/jdi.13066. Epub 2019 May 28.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/31033218/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject aged from 20 to 75 years old with type 2 diabetes mellitus(T2DM)\n* The subject with hemoglobin A1c ≧7.5% - \\<10.5 %\n* The subject who has been receiving a stable dose and regimen of GLP-1 analogue over 8 weeks before Screening test\n\nExclusion Criteria:\n\n* The subject with type 1 diabetes mellitus\n* The subject with Pregnancy or lactation\n* The subject with Fasting Plasma Glucose ≧ 270 mg/dl\n* The subject with history of metabolic acidosis, including diabetic ketoacidosis ,within 1 year prior to screening\n* The subject with myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months\n* The subject with serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women\n* The subject with aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times the upper limit of the reference range at the central laboratory test facility\n* The subject has received treatment with another investigational product or non-approved drug 3 months before screening\n* The subject with history of Tofogliflozin therapy\n* The subject with estimated glomerular filtration rate of \\<30 mL/min/1.73 m\\^2\n* The subject who frequently experiencing orthostatic hypotension\n* The subject systolic blood pressure of ≧ 180 or mmHg of diastolic blood pressure of ≧ 100 mmHg\n* The subject required a change in the dosing regiment for the following drugs within 4 weeks before screening : Lipid-lowering drug , Antihypertensive drug, Thyroid hormone drug , Uric acid lowering drug'}, 'identificationModule': {'nctId': 'NCT02537834', 'briefTitle': 'Tofogliflozin GLP-1 Analogue Combination Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Company, Ltd.'}, 'officialTitle': 'An Open-Label, Multicenter Study to Evaluate 52-Week Long-Term Safety, Tolerability and Efficacy of Tofogliflozin With Glucagon-like Peptide-1(GLP-1) Analogue Treatment In Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'DEBT02'}, 'secondaryIdInfos': [{'id': 'TOFOGL07279', 'type': 'OTHER', 'domain': 'Sanofi'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tofogliflozin ＋GLP-1 analogue', 'description': 'Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.', 'interventionNames': ['Drug: Tofogliflozin', 'Drug: GLP-1 analogue']}], 'interventions': [{'name': 'Tofogliflozin', 'type': 'DRUG', 'otherNames': ['DEBERZA', 'APLEWAY'], 'armGroupLabels': ['Tofogliflozin ＋GLP-1 analogue']}, {'name': 'GLP-1 analogue', 'type': 'DRUG', 'armGroupLabels': ['Tofogliflozin ＋GLP-1 analogue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '456-0058', 'city': 'Atsuta-ku', 'state': 'Aichi-ken', 'country': 'Japan'}, {'zip': '455-0018', 'city': 'Minato-ku', 'state': 'Aichi-ken', 'country': 'Japan'}, {'zip': '292-0038', 'city': 'Kisarazu', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.38329, 'lon': 139.93254}}, {'zip': '379-0116', 'city': 'Annaka', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.33011, 'lon': 138.89585}}, {'zip': '311-0113', 'city': 'Naka', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.05, 'lon': 140.16667}}, {'zip': '252-0302', 'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '714-0043', 'city': 'Kasaoka', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.50597, 'lon': 133.50391}}, {'zip': '329-0433', 'city': 'Shimono', 'state': 'Tochigi', 'country': 'Japan'}, {'zip': '123-0845', 'city': 'Adachi-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '103-0027', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '181-0013', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kowa Company, Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}