Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01944618
Status:
TERMINATED
Last Update Posted:
2016-09-13
First Post:
2013-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)
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': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Participant Data obtained to 30Sep2015:\n\nBaseline data: 447 6 month data: 253 Program terminated: recruitment target not met. No analysis will be provided.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2013-09-13', 'studyFirstSubmitQcDate': '2013-09-13', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rates of adverse events, specifically genital infections, urinary tract infections, increased haematocrit, renal impairment, hepatic impairment, bone fractures and cancers, in particular breast, bladder, and prostate cancers', 'timeFrame': 'Up to 6 months', 'description': 'Assessed in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice'}, {'measure': 'Any early adverse effects as a result of drug interactions in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice', 'timeFrame': 'Up to 6 months'}, {'measure': 'Incidence rates of spontaneously reported hypoglycaemia in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice', 'timeFrame': 'Up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Rate of prescribing of Forxiga after its introduction to routine Australian clinical practice', 'timeFrame': 'Upto 6 months'}, {'measure': 'Indication for prescription of Forxiga in routine Australian clinical practice', 'timeFrame': 'Upto 6 months'}, {'measure': 'Change in efficacy and safety variables after treatment with Forxiga for at least 3 months', 'timeFrame': 'Baseline and 3 months', 'description': 'Including:\n\n* HbA1c\n* Weight\n* Systolic blood pressure\n* Diastolic blood pressure\n* Heart rate\n* Serum creatinine\n* Estimated glomerular filtration rate\n* Liver function tests \\[Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or bilirubin\\]'}, {'measure': 'Subgroup analyses may be conducted for selected safety parameters', 'timeFrame': 'Upto 6 months', 'description': 'Subgroups to be evaluated will include gender, age, diabetes duration, concomitant medication, past medical history, and measured laboratory variables (if available)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The study purpose is to assess adverse events in patients with Type 2 diabetes who have newly been prescribed Forxiga for the management of glycemic control', 'detailedDescription': 'Observational Model: Other: A post-marketing evaluation of the safety of Forxiga through an observational prescription adverse event monitoring program (registry-based monitoring program) is warranted to assess real-world incidence of adverse events in routine clinical practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Type 2 Diabetes whom the Healthcare professional (HCP) would consider as suitable candidates for Forxiga treatment will be invited to participate in the program during routine clinical assessment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with Type 2 Diabetes who are:\n\n* Prescribed Forxiga for glycaemic management AND\n* Who have the ability to provide informed consent\n\nExclusion Criteria:\n\nPatients with whom use of Forxiga is contraindicated:\n\n* Patients with Type 1 Diabetes\n* Patients with moderate to severe renal impairment \\[Creatinine clearance (CrCl) \\<60 mL/min or estimated glomerular filtration rate (eGFR) \\<60mL/min/1.73m²\\]\n\nAdditional exclusion criteria:\n\n* Age \\>75 years\n* Concomitant use of loop diuretics or pioglitazone\n* Patients who are currently on another SGLT2 inhibitor'}, 'identificationModule': {'nctId': 'NCT01944618', 'acronym': 'forREAL', 'briefTitle': 'forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'forREAL: FORXIGA (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) PRESCRIPTION EVENT MONITORING PROGRAM', 'orgStudyIdInfo': {'id': 'MB102-209'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'T2DM patients newly prescribed Forxiga', 'description': 'A post-marketing evaluation of the safety of Forxiga (10 mg tablets, orally once daily for 6 months) through an observational prescription adverse event monitoring program (registry-based monitoring program) is warranted to assess real-world incidence of adverse events in routine clinical practice.', 'interventionNames': ['Drug: Forxiga']}], 'interventions': [{'name': 'Forxiga', 'type': 'DRUG', 'otherNames': ['Dapagliflozin'], 'description': 'FORXIGA is a prescription medicine used with diet, exercise and sometimes other medicines (which may include metformin; insulin; a sulfonylurea medicine such as gliclazide, glimepiride and glibenclamide; or a dipeptidyl peptidase-4 inhibitor \\[DPP 4 inhibitor\\] such as sitagliptin or saxagliptin) to control the levels of blood sugar (glucose) in patients with type 2 diabetes mellitus.', 'armGroupLabels': ['T2DM patients newly prescribed Forxiga']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'VIC 3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}], 'overallOfficials': [{'name': 'Sophia Zoungas, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Monash University'}, {'name': 'Christopher Reid, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Monash University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Monash University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}