Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01261494
Last Updated: 2011-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
97 participants
INTERVENTIONAL
2010-12-31
2011-06-30
Brief Summary
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And 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.
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Detailed Description
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* 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);
* Treatment period: 12 weeks;
* Follow-up period: 2 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GFT505 80mg
GFT505 80mg
hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast
Matching placebo
Placebo
hard gelatin capsules,oral administration,4 capsules per day before breakfast
Interventions
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GFT505 80mg
hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast
Placebo
hard gelatin capsules,oral administration,4 capsules per day before breakfast
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index ≥27 and ≤45 kg/m².
* 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.
* HbA1c ≥ 7.0% and \<9.5%.
* Antibody glutamate decarboxylase acid (Anti-GAD) negative for patients aged less than 40 years.
Exclusion Criteria
* Blood Pressure \> 160 / 95 mmHg.
* Lipid-lowering drugs such as fibrates.
* Fasting Plasma Glucose (FPG) ≥ 240 mg/dL.
* Triglycerides (TG) \> 400 mg/dL.
18 Years
75 Years
ALL
No
Sponsors
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Genfit
INDUSTRY
Responsible Party
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Genfit
Principal Investigators
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Rémy HANF, Development Director
Role: STUDY_DIRECTOR
Genfit, France
Bertrand CARIOU, Pr.
Role: STUDY_CHAIR
University Hospital of Nantes, France
Locations
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Site n°12
Banja Luka, , Bosnia and Herzegovina
Site n°11
Sarajevo, , Bosnia and Herzegovina
Site n°22
Riga, , Latvia
Site n°21
Riga, , Latvia
Site n°23
Valmiera, , Latvia
Site n°41
Bălţi, , Moldova
Site n°42
Chisinau, , Moldova
Site n°43
Chisinau, , Moldova
Site n°33
Bitola, , North Macedonia
Site n°31
Skopje, , North Macedonia
Site n°32
Skopje, , North Macedonia
Site n°72
Oradea, Bihor County, Romania
Site n°66
Buzău, Buzău, Romania
Site n°64
Cluj-Napoca, Cluj, Romania
Site n°65
Baia Mare, Maramureş, Romania
Site n°63
Târgu Mureş, Mureș County, Romania
Site n°62
Târgu Mureş, Mureș County, Romania
Site n°71
Ploieşti, Prahova, Romania
Site n°70
Ploieşti, Prahova, Romania
Site n°61
Sibiu, Sibiu County, Romania
Site n°67
Bucharest, , Romania
Site n°69
Bucharest, , Romania
Site n°68
Bucharest, , Romania
Site n°52
Belgrade, , Serbia
Site n°53
Belgrade, , Serbia
Site n°56
Belgrade, , Serbia
Site n°54
Kragujevac, , Serbia
Site n°51
Niš, , Serbia
Countries
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Other Identifiers
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2010-021986-60
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GFT505-210-5
Identifier Type: -
Identifier Source: org_study_id
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