Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-09 @ 12:44 PM
Study NCT ID:
NCT03269058
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2017-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2017-08-25', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline the rate of production of VLDL Apo B', 'timeFrame': '15 days before treatment initiation, Day 0, Day 90 and Day 180'}, {'measure': 'Change from baseline the rate of production of IDL Apo B', 'timeFrame': '15 days before treatment initiation, Day 0, Day 90 and Day 180'}, {'measure': 'Change from baseline the rate of production of LDL Apo B', 'timeFrame': '15 days before treatment initiation, Day 0, Day 90 and Day 180'}, {'measure': 'Change from baseline the rate of production of HDL Apo A1', 'timeFrame': '15 days before treatment initiation, Day 0, Day 90 and Day 180'}, {'measure': 'Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B', 'timeFrame': '15 days before treatment initiation, Day 0, Day 90 and Day 180'}, {'measure': 'Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B', 'timeFrame': '15 days before treatment initiation, Day 0, Day 90 and Day 180'}, {'measure': 'Change from baseline the Fractional Catabolic Rate of IDL Apo B', 'timeFrame': '15 days before treatment initiation, Day 0, Day 90 and Day 180'}, {'measure': 'Change from baseline the Fractional Catabolic Rate of LDL Apo B', 'timeFrame': '15 days before treatment initiation, Day 0, Day 90 and Day 180'}, {'measure': "Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1", 'timeFrame': '15 days before treatment initiation, Day 0, Day 90 and Day 180'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type-2 Diabetes', 'Oral Antidiabetics']}, 'descriptionModule': {'briefSummary': 'This study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca.\n\nThe information will:\n\n* reveal what is not working properly\n* make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning\n\nThis biomedical research will take place at the University Hospitals of DIJON and NANTES.\n\n* 28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will be given the placebo.\n* The study treatment will be randomised: patients will be given either Dapagliflozin or the placebo. The treatment duration is 6 months.\n* Moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. This will involve administering amino acids that have been specifically synthesised for this purpose.\n* Participation in the study will last 6 months and include 4 protocol visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* persons who have provided written consent\n* type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or DPPIV inhibitors)\n* Stable treatment for 3 months\n* HbA1c between 7.5% and 10%\n* Age between 30 and 65 years\n* BMI between 25 and 35 kg/m²\n* Triglycerides \\< 300 mg/dl\n* Half of the patients being treated with statins\n* eGFR \\> 75 ml/min/1.73 m² at inclusion\n\nExclusion Criteria:\n\n* persons without national health insurance cover\n* patients treated with Insulin or a GLP-1 agonist\n* Patients under guardianship\n* patients treated with lipid-lowering drugs (except statins for 50% of patients)\n* kidney failure\n* liver failure or abnormal liver function ASAT or ALAT \\>3 x upper limit of normal\n* total bilirubin \\>2mg/dl\n* intestinal disease\n* serological evidence of an active liver infection (surface antigen of hepatitis B, hepatitis C antibodies, hepatitis B IgM antibodies)\n* Pregnancy, breastfeeding\n* hypersensitivity to the active substance or to excipients\n* patients with volume depletion, for example due to an acute disease (gastro-intestinal disease)\n* patients treated with loop diuretics or thiazides'}, 'identificationModule': {'nctId': 'NCT03269058', 'acronym': 'Cinétique DAPA', 'briefTitle': 'Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'VERGES AZ 2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients not treated with statins', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Patients treated with statins', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Placebos']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'Dapagliflozin 10 mg daily per os', 'armGroupLabels': ['Patients not treated with statins', 'Patients treated with statins']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo of Dapagliflozin per day per os', 'armGroupLabels': ['Patients not treated with statins', 'Patients treated with statins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}