Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus

Tracking Information
First Submitted Date ICMJE	December 13, 2010
First Posted Date ICMJE	December 16, 2010
Last Update Posted Date	July 13, 2011
Study Start Date ICMJE	December 2010
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 15, 2010)	HbA1c [ Time Frame: 12 weeks ]; 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).
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01261494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 15, 2010)	Oral Glucose Tolerance Test (OGTT) [ Time Frame: 12 weeks ]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.; Fasting Plasma Glucose [ Time Frame: 12 weeks ]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).; Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)] [ Time Frame: 12 weeks ]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).
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus
Official Title ICMJE	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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Type II Diabetes Mellitus
Intervention ICMJE	Drug: GFT505 80mg hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast; Drug: Placebo hard gelatin capsules,oral administration,4 capsules per day before breakfast
Study Arms	Experimental: GFT505 80mg Intervention: Drug: GFT505 80mg; Placebo Comparator: Matching placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 12, 2011)	97
Original Estimated Enrollment ICMJE; (submitted: December 15, 2010)	120
Actual Study Completion Date	June 2011
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Bosnia and Herzegovina, Latvia, Macedonia, The Former Yugoslav Republic of, Moldova, Republic of, Romania, Serbia
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01261494
Other Study ID Numbers ICMJE	GFT505-210-5; 2010-021986-60 ( EudraCT Number )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Product Development Department, Genfit
Study Sponsor ICMJE	Genfit
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Rémy HANF, Development Director Genfit, France Study Chair: Bertrand CARIOU, Pr. University Hospital of Nantes, France
PRS Account	Genfit
Verification Date	July 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP