Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-06 @ 7:08 AM
Study NCT ID:
NCT01261494
Status:
COMPLETED
Last Update Posted:
2011-07-13
First Post:
2010-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study With GFT505 (80mg) Versus Placebo in 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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585906', 'term': '2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid'}]}}, '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': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-12', 'studyFirstSubmitDate': '2010-12-13', 'studyFirstSubmitQcDate': '2010-12-15', 'lastUpdatePostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '12 weeks', 'description': 'To evaluate after 12 weeks of oral administration of double blind treatment the change from baseline in HbA1c level achieved with GFT505 80mg versus placebo. Evaluation will be made during the selection period, prior any drug intake, and 4, 8, 12 weeks after the first treatment intake as well as 2 weeks after the last treatment intake (follow up period).'}], 'secondaryOutcomes': [{'measure': 'Oral Glucose Tolerance Test (OGTT)', 'timeFrame': '12 weeks', 'description': 'To evaluate the changes from baseline to end of treatment in OGTT parameters. Evaluation will be made prior the first treatment intake and 12 weeks after the first treatment intake.'}, {'measure': 'Fasting Plasma Glucose', 'timeFrame': '12 weeks', 'description': 'To evaluate the changes from baseline to end of treatment in fasting plasma Glucose. Evaluation will be made during the selection period, prior any drug intake, and 4, 8, 12 weeks after the first treatment intake as well as 2 weeks after the last treatment intake (follow up period).'}, {'measure': 'Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)]', 'timeFrame': '12 weeks', 'description': 'To evaluate the changes from baseline to end of treatment in insulin resistance index. Evaluation will be made during the selection period, prior any drug intake, and 4, 8, 12 weeks after the first treatment intake as well as 2 weeks after the last treatment intake (follow up period).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 2', 'Glucose Metabolism Disorders', 'Metabolic Diseases', 'Cardiovascular Diseases', 'PPARs', 'OGTT'], 'conditions': ['Type II Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study is expected to demonstrate the anti-diabetic efficacy of 3-months treatment with GFT505 (80 mg/d) on Glycosylated Haemoglobin A1c (HbA1C) and fasting plasma glucose.\n\nAnd to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 for 12 weeks in patients with type 2 diabetes mellitus.', 'detailedDescription': 'The study period per patient is 16-20 weeks maximum and is conducted as follows :\n\n* Run-in period: 2 weeks or 6 weeks for patients under fibrate treatment at screening (4 weeks fibrate wash-out + 2 weeks placebo run-in);\n* Treatment period: 12 weeks;\n* Follow-up period: 2 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or post-menopausal female (defined as \\>12 months since last menstrual period) or surgical menopause. If hormonal replacement therapy, it should be stable at least for 6 months prior to screening.\n* Body Mass Index ≥27 and ≤45 kg/m².\n* Drug-Naive patients with type 2 diabetes mellitus (non insulin dependent diabetes). Patients should not be treated by insulin or other diabetes medication for the last 3 months prior to screening. Patients treated for less than 4 weeks with insulin may be included in the study.\n* HbA1c ≥ 7.0% and \\<9.5%.\n* Antibody glutamate decarboxylase acid (Anti-GAD) negative for patients aged less than 40 years.\n\nExclusion Criteria:\n\n* Type I Diabetes Mellitus.\n* Blood Pressure \\> 160 / 95 mmHg.\n* Lipid-lowering drugs such as fibrates.\n* Fasting Plasma Glucose (FPG) ≥ 240 mg/dL.\n* Triglycerides (TG) \\> 400 mg/dL.'}, 'identificationModule': {'nctId': 'NCT01261494', 'briefTitle': 'Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genfit'}, 'officialTitle': 'A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80mg) Orally Administered Once Daily for 12 Weeks in Patients With Type 2 Diabetes Mellitus. A Multicentre, Randomised, Double Blind, Placebo-Controlled Study.', 'orgStudyIdInfo': {'id': 'GFT505-210-5'}, 'secondaryIdInfos': [{'id': '2010-021986-60', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GFT505 80mg', 'interventionNames': ['Drug: GFT505 80mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GFT505 80mg', 'type': 'DRUG', 'description': 'hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast', 'armGroupLabels': ['GFT505 80mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'hard gelatin capsules,oral administration,4 capsules per day before breakfast', 'armGroupLabels': ['Matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78000', 'city': 'Banja Luka', 'country': 'Bosnia and Herzegovina', 'facility': 'Site n°12', 'geoPoint': {'lat': 44.77879, 'lon': 17.20629}}, {'zip': '71000', 'city': 'Sarajevo', 'country': 'Bosnia and Herzegovina', 'facility': 'Site n°11', 'geoPoint': {'lat': 43.84864, 'lon': 18.35644}}, {'zip': 'LV 1002', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Site n°22', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV 1004', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Site n°21', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV4201', 'city': 'Valmiera', 'country': 'Latvia', 'facility': 'Site n°23', 'geoPoint': {'lat': 57.54108, 'lon': 25.42751}}, {'zip': '3112', 'city': 'Bălţi', 'country': 'Moldova', 'facility': 'Site n°41', 'geoPoint': {'lat': 47.76291, 'lon': 27.92854}}, {'zip': '2025', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Site n°42', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '2068', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Site n°43', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '7000', 'city': 'Bitola', 'country': 'North Macedonia', 'facility': 'Site n°33', 'geoPoint': {'lat': 41.03226, 'lon': 21.33553}}, {'zip': '1000', 'city': 'Skopje', 'country': 'North Macedonia', 'facility': 'Site n°31', 'geoPoint': {'lat': 41.99646, 'lon': 21.43141}}, {'zip': '1000', 'city': 'Skopje', 'country': 'North Macedonia', 'facility': 'Site n°32', 'geoPoint': {'lat': 41.99646, 'lon': 21.43141}}, {'zip': '410167', 'city': 'Oradea', 'state': 'Bihor County', 'country': 'Romania', 'facility': 'Site n°72', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'zip': '120203', 'city': 'Buzău', 'state': 'Buzău', 'country': 'Romania', 'facility': 'Site n°66', 'geoPoint': {'lat': 45.15, 'lon': 26.83333}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'country': 'Romania', 'facility': 'Site n°64', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '430123', 'city': 'Baia Mare', 'state': 'Maramureş', 'country': 'Romania', 'facility': 'Site n°65', 'geoPoint': {'lat': 47.65729, 'lon': 23.56808}}, {'zip': '540098', 'city': 'Târgu Mureş', 'state': 'Mureș County', 'country': 'Romania', 'facility': 'Site n°63', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '540142', 'city': 'Târgu Mureş', 'state': 'Mureș County', 'country': 'Romania', 'facility': 'Site n°62', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '100163', 'city': 'Ploieşti', 'state': 'Prahova', 'country': 'Romania', 'facility': 'Site n°71', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'zip': '100342', 'city': 'Ploieşti', 'state': 'Prahova', 'country': 'Romania', 'facility': 'Site n°70', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'zip': '550245', 'city': 'Sibiu', 'state': 'Sibiu County', 'country': 'Romania', 'facility': 'Site n°61', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'zip': '020045', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Site n°67', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '020045', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Site n°69', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '020475', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Site n°68', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Site n°52', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Site n°53', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Site n°56', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '34000', 'city': 'Kragujevac', 'country': 'Serbia', 'facility': 'Site n°54', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}, {'zip': '18000', 'city': 'Niš', 'country': 'Serbia', 'facility': 'Site n°51', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}], 'overallOfficials': [{'name': 'Rémy HANF, Development Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genfit, France'}, {'name': 'Bertrand CARIOU, Pr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of Nantes, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genfit', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Product Development Department', 'oldOrganization': 'Genfit'}}}}