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Completed

NCT Number: NCT01261494

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

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.

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Key information

Conditions

Type II Diabetes Mellitus Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site n°12, Banja Luka, Bosnia and Herzegovina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GFT505 80mg

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Genfit

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 16, 2010
Registry last updated
Jul 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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