Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-04 @ 5:58 AM
Study NCT ID:
NCT02201004
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2014-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TOFO Insulin 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"}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-10', 'studyFirstSubmitDate': '2014-07-23', 'studyFirstSubmitQcDate': '2014-07-23', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c from baseline', 'timeFrame': '16 weeks after first intake of investigational product'}], 'secondaryOutcomes': [{'measure': 'Change of Body Weight (BW) from baseline', 'timeFrame': '16 weeks after first intake of investigational product'}, {'measure': 'Change of FPG from baseline', 'timeFrame': '16 weeks after first intake of investigational product'}, {'measure': 'Change of PPG from baseline', 'timeFrame': '16 weeks after first intake of investigational product'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'Up to 52 weeks from the first intake of investigational medicinal product'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '28371205', 'type': 'RESULT', 'citation': 'Terauchi Y, Tamura M, Senda M, Gunji R, Kaku K. Efficacy and safety of tofogliflozin in Japanese patients with type 2 diabetes mellitus with inadequate glycaemic control on insulin therapy (J-STEP/INS): Results of a 16-week randomized, double-blind, placebo-controlled multicentre trial. Diabetes Obes Metab. 2017 Oct;19(10):1397-1407. doi: 10.1111/dom.12957. Epub 2017 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\nTo assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus.\n\nTo assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks.\n\nSecondary Objectives:\n\nTo assess the effects of tofogliflozin in comparison to placebo on:\n\n* Body weight\n* Fasting plasma glucose (FPG)\n* Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.', 'detailedDescription': 'The total study duration from screening for a patient can be approximately up to 1 year, including a screening period of 2 weeks, double-blinded placebo controlled treatment period of 16 weeks, an open-labeled extension period of 36 weeks, and a follow-up period of 3 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients aged 20-75 years old with type 2 diabetes mellitus (T2DM).\n* Hemoglobin A1c ≥7.5% - ≤10.5% and FPG ≤220 mg/dL.\n* Basal bolus (BB), Bolus, Premix, Basal supported oral therapy (BOT) regimens used for more than 12 weeks before screening.\n* Stable dose (-/+20%) of insulin and no change in the dose of oral hypoglycemic agents for more than 12 weeks before screening.\n* Only Dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (BOT) regimen.\n* Body mass index (BMI) ≥18.5 kg/m\\^2 and \\<35.0 kg/m\\^2.\n* No change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening.\n\nExclusion criteria:\n\n* Type 1 diabetes mellitus.\n* Pregnancy or lactation.\n* Severely uncontrolled glycemic situation.\n* History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening.\n* History of myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months.\n* A measured serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women.\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of the reference range at the central laboratory test facility.\n* Has previously received treatment with the investigational product.\n* Has received treatment with another investigational product or non-approved drug within 3 months before tests for provisional enrolment.\n* Corticosteroid therapy for 14 or more days in total within 8 weeks before tests for provisional enrolment (excluding those used for localized effects, such as drugs for topical \\[skin\\] application, eye drops and sprays).\n* Patients who are frequently experiencing orthostatic hypotension.\n* Required a change in the dosing regimen for the following drugs within 4 weeks before tests for provisional enrolment:\n* Lipid-lowering drug\n* Antihypertensive drug\n* Thyroid hormone preparation\n* Uric acid lowering drug\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02201004', 'briefTitle': 'TOFO Insulin Combination Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double Blind Placebo Controlled 2-Arm Parallel Group, Multicenter Study With A 16-Week Treatment Assessing The Efficacy And Safety, And 52-Week Long Term Safety Including 36-Week Open Label Extension Of Tofogliflozin With Insulin Treatment In Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'TOFOGL07061'}, 'secondaryIdInfos': [{'id': 'U1111-1159-5316', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tofogliflozin', 'description': 'Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment.', 'interventionNames': ['Drug: TOFOGLIFLOZIN CSG452', 'Drug: insulin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.', 'interventionNames': ['Drug: TOFOGLIFLOZIN CSG452', 'Drug: insulin', 'Drug: placebo']}], 'interventions': [{'name': 'TOFOGLIFLOZIN CSG452', 'type': 'DRUG', 'otherNames': ['Apleway', 'Deberza'], 'description': 'Pharmaceutical form:tablet Route of administration: oral', 'armGroupLabels': ['placebo', 'tofogliflozin']}, {'name': 'insulin', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution Route of administration: subcutaneous', 'armGroupLabels': ['placebo', 'tofogliflozin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form:tablet Route of administration: oral', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adachi-ku', 'country': 'Japan', 'facility': 'Investigational Site Number 392-028'}, {'city': 'Atsugi-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-007'}, {'city': 'Chuoh-ku', 'country': 'Japan', 'facility': 'Investigational Site Number 392-026'}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Investigational Site Number 392-021', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Ichihara-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-002'}, {'city': 'Iruma-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-012'}, {'city': 'Kawaguchi-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-003'}, {'city': 'Kitakyusyu-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-014'}, {'city': 'Kobe', 'country': 'Japan', 'facility': 'Investigational Site Number 392-027', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Koga-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-004'}, {'city': 'Kunitachi-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-022'}, {'city': 'Kurume-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-019'}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Investigational Site Number 392-001', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Investigational Site Number 392-024', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Matsudo-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-006'}, {'city': 'Mito', 'country': 'Japan', 'facility': 'Investigational Site Number 392-008', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'city': 'Musashino-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-030'}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Investigational Site Number 392-029', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Ōtsu', 'country': 'Japan', 'facility': 'Investigational Site Number 392-017', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}, {'city': 'Sagamihara-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-011'}, {'city': 'Sakaishi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-020', 'geoPoint': {'lat': 33.41239, 'lon': 132.71218}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Investigational Site Number 392-010', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sendai', 'country': 'Japan', 'facility': 'Investigational Site Number 392-016', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Shinjuku-ku', 'country': 'Japan', 'facility': 'Investigational Site Number 392-018'}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Investigational Site Number 392-005', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Suita-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-031'}, {'city': 'Sumida-ku', 'country': 'Japan', 'facility': 'Investigational Site Number 392-015'}, {'city': 'Sunto-gun', 'country': 'Japan', 'facility': 'Investigational Site Number 392-023'}, {'city': 'Tokorozawa-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392-013'}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Investigational Site Number 392-025', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kowa Company, Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}