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Clinical Trial Details

Trial ID: L1895
Source ID: NCT01261494
Associated Drug: Gft505 80mg
Title: Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type II Diabetes Mellitus
Interventions: DRUG: GFT505 80mg|DRUG: Placebo
Outcome Measures: Primary: HbA1c, 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)., 12 weeks | Secondary: Oral Glucose Tolerance Test (OGTT), 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., 12 weeks|Fasting Plasma Glucose, 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)., 12 weeks|Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)], 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)., 12 weeks
Sponsor/Collaborators: Sponsor: Genfit
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 97
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-12
Completion Date: 2011-06
Results First Posted:
Last Update Posted: 2011-07-13
Locations: Site n°12, Banja Luka, 78000, Bosnia and Herzegovina|Site n°11, Sarajevo, 71000, Bosnia and Herzegovina|Site n°22, Riga, LV 1002, Latvia|Site n°21, Riga, LV 1004, Latvia|Site n°23, Valmiera, LV4201, Latvia|Site n°33, Bitola, 7000, Macedonia, The Former Yugoslav Republic of|Site n°31, Skopje, 1000, Macedonia, The Former Yugoslav Republic of|Site n°32, Skopje, 1000, Macedonia, The Former Yugoslav Republic of|Site n°41, Balti, 3112, Moldova, Republic of|Site n°42, Chisinau, 2025, Moldova, Republic of|Site n°43, Chisinau, 2068, Moldova, Republic of|Site n°72, Oradea, Bihor County, 410167, Romania|Site n°66, Buzau, Buzau County, 120203, Romania|Site n°64, Cluj Napoca, Cluj County, 400006, Romania|Site n°65, Baia Mare, Maramures County, 430123, Romania|Site n°63, Targu Mures, Mures County, 540098, Romania|Site n°62, Targu Mures, Mures County, 540142, Romania|Site n°71, Ploiesti, Prahova County, 100163, Romania|Site n°70, Ploiesti, Prahova County, 100342, Romania|Site n°61, Sibiu, Sibiu County, 550245, Romania|Site n°67, Bucharest, 020045, Romania|Site n°69, Bucharest, 020045, Romania|Site n°68, Bucharest, 020475, Romania|Site n°52, Belgrade, 11000, Serbia|Site n°53, Belgrade, 11000, Serbia|Site n°56, Belgrade, 11000, Serbia|Site n°54, Kragujevac, 34000, Serbia|Site n°51, Nis, 18000, Serbia
URL: https://clinicaltrials.gov/show/NCT01261494

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