MedTrace Logo

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

NCT01261494 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2011-07-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Rémy HANF, Development Director · Genfit, France

  • Bertrand CARIOU, Pr. · University Hospital of Nantes, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Bosnia and Herzegovina
  • Latvia
  • Moldova
  • North Macedonia
  • Romania
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01261494 on ClinicalTrials.gov