Clinical trial NCT01261494: Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type II Diabetes Mellitus
Keywords: Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Cardiovascular Diseases
PPARs
OGTT
Lead sponsor: Genfit
Sponsor class: INDUSTRY
First posted: 2010-12-16
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Detailed description: The study period per patient is 16-20 weeks maximum and is conducted as follows :

* 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.

Eligibility criteria: Inclusion Criteria:

* 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.
* 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:

* Type I Diabetes Mellitus.
* Blood Pressure \> 160 / 95 mmHg.
* Lipid-lowering drugs such as fibrates.
* Fasting Plasma Glucose (FPG) ≥ 240 mg/dL.
* Triglycerides (TG) \> 400 mg/dL.

Primary outcomes:
measure: HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Oral Glucose Tolerance Test (OGTT)
timeFrame: 12 weeks
measure: Fasting Plasma Glucose
timeFrame: 12 weeks
measure: Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)]
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: Site n°12
city: Sarajevo
country: Bosnia and Herzegovina
facility: Site n°11
city: Riga
country: Latvia
facility: Site n°22
city: Riga
country: Latvia
facility: Site n°21
city: Valmiera
country: Latvia
facility: Site n°23
city: Bitola
country: Macedonia, The Former Yugoslav Republic of
facility: Site n°33
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Site n°31
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Site n°32
city: Balti
country: Moldova, Republic of
facility: Site n°41
city: Chisinau
country: Moldova, Republic of
facility: Site n°42
city: Chisinau
country: Moldova, Republic of
facility: Site n°43
city: Oradea
country: Romania
facility: Site n°72
state: Bihor County
city: Buzau
country: Romania
facility: Site n°66
state: Buzau County
city: Cluj Napoca
country: Romania
facility: Site n°64
state: Cluj County
city: Baia Mare
country: Romania
facility: Site n°65
state: Maramures County
city: Targu Mures
country: Romania
facility: Site n°63
state: Mures County
city: Targu Mures
country: Romania
facility: Site n°62
state: Mures County
city: Ploiesti
country: Romania
facility: Site n°71
state: Prahova County
city: Ploiesti
country: Romania
facility: Site n°70
state: Prahova County
city: Sibiu
country: Romania
facility: Site n°61
state: Sibiu County
city: Bucharest
country: Romania
facility: Site n°67
city: Bucharest
country: Romania
facility: Site n°69
city: Bucharest
country: Romania
facility: Site n°68
city: Belgrade
country: Serbia
facility: Site n°52
city: Belgrade
country: Serbia
facility: Site n°53
city: Belgrade
country: Serbia
facility: Site n°56
city: Kragujevac
country: Serbia
facility: Site n°54
city: Nis
country: Serbia
facility: Site n°51
Study officials:
affiliation: Genfit, France
name: Rémy HANF, Development Director
role: STUDY_DIRECTOR
affiliation: University Hospital of Nantes, France
name: Bertrand CARIOU, Pr.
role: STUDY_CHAIR
References: