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

NCT01261494 | Completed Phase 2

• 2 other identifiers: GFT505-210-52010-021986-60
• Study Type: interventional
• Target: 97
• Locations: 6 countries
• Sites: 28

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.

Conditions

Type II Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Cardiovascular Diseases; PPARs; OGTT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Oral Glucose Tolerance Test (OGTT)

  12 weeks

• Fasting Plasma Glucose

  12 weeks

• Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)]

  12 weeks

Study Arms (2)

GFT505 80mg

EXPERIMENTAL

Drug: GFT505 80mg

Matching placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GFT505 80mg DRUG

hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast

GFT505 80mg

Placebo DRUG

hard gelatin capsules,oral administration,4 capsules per day before breakfast

Matching placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genfit: lead

Study Sites (28)

Site n°12

Banja Luka, 78000, Bosnia and Herzegovina

Location

Site n°11

Sarajevo, 71000, Bosnia and Herzegovina

Location

Site n°22

Riga, LV 1002, Latvia

Location

Site n°21

Riga, LV 1004, Latvia

Location

Site n°23

Valmiera, LV4201, Latvia

Location

Site n°41

Bălţi, 3112, Moldova

Location

Site n°42

Chisinau, 2025, Moldova

Location

Site n°43

Chisinau, 2068, Moldova

Location

Site n°33

Bitola, 7000, North Macedonia

Location

Site n°31

Skopje, 1000, North Macedonia

Location

Site n°32

Skopje, 1000, North Macedonia

Location

Site n°72

Oradea, Bihor County, 410167, Romania

Location

Site n°66

Buzău, Buzău, 120203, Romania

Location

Site n°64

Cluj-Napoca, Cluj, 400006, Romania

Location

Site n°65

Baia Mare, Maramureş, 430123, Romania

Location

Site n°63

Târgu Mureş, Mureș County, 540098, Romania

Location

Site n°62

Târgu Mureş, Mureș County, 540142, Romania

Location

Site n°71

Ploieşti, Prahova, 100163, Romania

Location

Site n°70

Ploieşti, Prahova, 100342, Romania

Location

Site n°61

Sibiu, Sibiu County, 550245, Romania

Location

Site n°67

Bucharest, 020045, Romania

Location

Site n°69

Bucharest, 020045, Romania

Location

Site n°68

Bucharest, 020475, Romania

Location

Site n°52

Belgrade, 11000, Serbia

Location

Site n°53

Belgrade, 11000, Serbia

Location

Site n°56

Belgrade, 11000, Serbia

Location

Site n°54

Kragujevac, 34000, Serbia

Location

Site n°51

Niš, 18000, Serbia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Cardiovascular Diseases

Interventions

2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rémy HANF, Development Director

  Genfit, France

  STUDY DIRECTOR

• Bertrand CARIOU, Pr.

  University Hospital of Nantes, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 16, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 13, 2011

Record last verified: 2011-07

Locations

BO (2); RO (12); LA (3); SE (5); MO (3); NO (3)