Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-22 @ 9:36 AM
Study NCT ID:
NCT04149067
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain
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'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1080}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '0.5% in Hb1Ac and 1.5 kg in body weight', 'timeFrame': '6 months +/- 3 months', 'description': 'The aim of the study is to assess the effectiveness of the SGLT2i (dapagliflozin) and DPP4i (Sitagliptin) over the composite endpoint of Hb1Ac and weight at six month of treatment.\n\nThe main variable is composite, including Hb1Ac and body weight. It will be evaluated the proportion of patient to achieve a change of 0.5% in Hb1Ac and 1.5 kg in body weight.\n\nIt was chosen sitagliptin because the researchers involved in this study have much experience with this molecule with a large number of patients already treated.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the results due to the use of SGLT2i/DPP4i', 'timeFrame': '6 months +/- 3 months', 'description': 'Assessment of the SGLT2i/DPP4i use in single, double or triple therapy and analysis of the baseline features of the patients at the beginning and at the end of the treatment, including the concomitant medication.'}, {'measure': 'Evaluate the security of the treatment', 'timeFrame': '6 months +/- 3 months', 'description': 'Study of the incidence of the urinary and genital infections as well as the hypoglycemia incidence and its severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to develop a retrospective, multicenter and observational study in Spain in real clinical practice to assess the employment of dapagliflozin and to compare its effectiveness and safety with the data of sitagliptin, a DPP4 inhibitor. This is a widely used molecule in Spain with a large safety profile. It was chosen as a comparator because of the number of patients treated and because it is a real alternative at the time of making a decision about the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years old with stable DM2 with antihyperglycaemic therapy, being included in their treatment dapagliflozin or sitagliptin medication.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with T2DM.\n2. Age: 18-75 years.\n3. Treatment with dapagliflozin or sitagliptin that started at least 6 months before the recruitment date.\n4. The patient must have at least two follow-up visits. The basal initial visit, where all the relevant information is collected and a second follow-up visit.\n5. The next information of the subjects should be available at the recruitment of the basal visit: Sex, age (years), date of diagnosis of T2DM, weight, height, systolic and diastolic blood pressure, body mass index (BMI: kg / m2), concomitant medication (antiHTA, statins, aspirin, etc.), glucose basal fasting (mg / dL), HbA1c (%) and estimated GFR by CKD-EPI (mL / min / 1.73m2).\n\n5\\. The patient must sign the informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Impediment of the patient to give him informed consent.\n2. Patients diagnosed with Type 1 Diabetes.\n3. Women with gestational diabetes.'}, 'identificationModule': {'nctId': 'NCT04149067', 'briefTitle': 'Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': 'Retrospective and Multicenter Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain', 'orgStudyIdInfo': {'id': 'FIS-DAP-2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dapagliflozin cohort', 'description': 'Patients diagnosed with type 2 diabetes that started dapagliflozin treatment at least 6 months before the beginning of the study.', 'interventionNames': ['Drug: Dapagliflozin']}, {'label': 'Sitagliptin cohort', 'description': 'Patients diagnosed with type 2 diabetes that started sitagliptin treatment at least 6 months before the beginning of the study.', 'interventionNames': ['Drug: Sitagliptin']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['iSGLT2'], 'description': 'Evaluation of the effectiveness and safety of the Dapagliflozin treatment.', 'armGroupLabels': ['Dapagliflozin cohort']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['iDPP4'], 'description': 'Evaluation of the effectiveness and safety of the Sitagliptin treatment.', 'armGroupLabels': ['Sitagliptin cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41009', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Cristóbal Morales Portillo', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Cristobal Morales Portillo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario Virgen Macarena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}