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

Type II Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261494
• Other study ID #: GFT505-210-5
• Secondary ID: 2010-021986-60
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2010
• Last updated: July 12, 2011
• Start date: December 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Genfit
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics CommitteeRomania: National Medicines AgencyLatvia: Institutional Review BoardLatvia: State Agency of MedicinesBosnia: Federal Ministry of HealthMacedonia: Ethics CommitteeMacedonia: Ministry of HealthMoldova: Ministry of HealthSerbia: Ethics CommitteeSerbia and Montenegro: Agency for Drugs and Medicinal Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Bosnia and Herzegovina	Site n°12	Banja Luka
Bosnia and Herzegovina	Site n°11	Sarajevo
Latvia	Site n°21	Riga
Latvia	Site n°22	Riga
Latvia	Site n°23	Valmiera
Macedonia, The Former Yugoslav R	Site n°33	Bitola
Macedonia, The Former Yugoslav R	Site n°31	Skopje
Macedonia, The Former Yugoslav R	Site n°32	Skopje
Moldova, Republic of	Site n°41	Balti
Moldova, Republic of	Site n°42	Chisinau
Moldova, Republic of	Site n°43	Chisinau
Romania	Site n°65	Baia Mare	Maramures County
Romania	Site n°67	Bucharest
Romania	Site n°68	Bucharest
Romania	Site n°69	Bucharest
Romania	Site n°66	Buzau	Buzau County
Romania	Site n°64	Cluj Napoca	Cluj County
Romania	Site n°72	Oradea	Bihor County
Romania	Site n°70	Ploiesti	Prahova County
Romania	Site n°71	Ploiesti	Prahova County
Romania	Site n°61	Sibiu	Sibiu County
Romania	Site n°62	Targu Mures	Mures County
Romania	Site n°63	Targu Mures	Mures County
Serbia	Site n°52	Belgrade
Serbia	Site n°53	Belgrade
Serbia	Site n°56	Belgrade
Serbia	Site n°54	Kragujevac
Serbia	Site n°51	Nis

Sponsors (1)

Lead Sponsor	Collaborator
Genfit

Countries where clinical trial is conducted

Bosnia and Herzegovina,  Latvia,  Macedonia, The Former Yugoslav Republic of,  Moldova, Republic of,  Romania,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
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	No
Secondary	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	Yes
Secondary	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	No