Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-21 @ 12:18 PM
Study NCT ID:
NCT01071850
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2010-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'C572941', 'term': 'ipragliflozin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 412}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'dispFirstSubmitDate': '2012-04-29', 'completionDateStruct': {'date': '2011-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2010-02-18', 'dispFirstSubmitQcDate': '2012-04-29', 'studyFirstSubmitQcDate': '2010-02-18', 'dispFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline in fasting plasma glucose (FPG)', 'timeFrame': '12 weeks'}, {'measure': 'Proportion of subjects achieving target goal of HbA1c <7.0%', 'timeFrame': '12 weeks'}, {'measure': 'Proportion of subjects achieving target goal of HbA1c <6.5%', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASP1941', 'Metformin', 'Type 2 diabetes', 'diabetes'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '31606880', 'type': 'DERIVED', 'citation': 'Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.'}, {'pmid': '23276620', 'type': 'DERIVED', 'citation': 'Fonseca VA, Ferrannini E, Wilding JP, Wilpshaar W, Dhanjal P, Ball G, Klasen S. Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus. J Diabetes Complications. 2013 May-Jun;27(3):268-73. doi: 10.1016/j.jdiacomp.2012.11.005. Epub 2012 Dec 29.'}], 'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/study.aspx?ID=1', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has been diagnosed with type 2 diabetes\n* Subject has a HbA1c value between 6.8 and 9.5%\n* Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study\n* Subject is on a stable diet and exercise program\n* Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study\n\nExclusion Criteria:\n\n* Subject has type 1 diabetes mellitus\n* Subject is using insulin therapy\n* Subject has a serum creatinine higher than upper limit of normal\n* Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal\n* Subject has persistent, uncontrolled severe hypertension as indicated by a\n\nsystolic blood pressure \\>180 mmHg or a diastolic blood pressure of\n\n\\>110mmHg\n\n* Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months\n* Subject is known to have hepatitis or be a carrier of hepatitis B surface\n\nantigen, hepatitis C virus antibody or is known positive for HIV1 and/or\n\nHIV2\n\n* Subject has a history of lactic acidosis\n* Subject has a history of drug and alcohol abuse/dependency within last 12\n\nmonths\n\n* Subject has had a malignancy in the last 5 years, except for successfully\n\ntreated basal or squamous cell carcinoma of the skin or of the cervix\n\n* Subject has a symptomatic urinary tract infection or genital infection\n* Female subject is lactating\n* Subject has an unstable medical or psychiatric illness'}, 'identificationModule': {'nctId': 'NCT01071850', 'briefTitle': 'A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '1941-CL-0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP1941 lowest dose', 'description': 'oral tablet', 'interventionNames': ['Drug: ipragliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'ASP1941 low dose', 'description': 'oral tablet', 'interventionNames': ['Drug: ipragliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'ASP1941 high dose', 'description': 'oral tablet', 'interventionNames': ['Drug: ipragliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'ASP1941 highest dose', 'description': 'oral tablet', 'interventionNames': ['Drug: ipragliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'oral tablet', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'oral tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ipragliflozin', 'type': 'DRUG', 'otherNames': ['ASP1941'], 'description': 'oral tablet', 'armGroupLabels': ['ASP1941 high dose', 'ASP1941 highest dose', 'ASP1941 low dose', 'ASP1941 lowest dose']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['Metformin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35215', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Parkway Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35565', 'city': 'Haleyville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Winston Technology Research, LLC', 'geoPoint': {'lat': 34.22649, 'lon': -87.62141}}, {'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Desert Clinical Research', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Central Phoenix Medical Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '71603', 'city': 'Pine Bluff', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Paul W. 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Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}