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.

GENFIT0 sites120 target enrollmentOctober 11, 2010

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: GENFIT
Enrollment: 120
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 11, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GENFIT

Eligibility Criteria

Inclusion Criteria

•Patients must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
•1\. Provide written informed consent prior to enrolment.
•2\. 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.
•3\. Aged from 18 to 75 years.
•4\. BMI \=27 and \=45 kg/m².
•5\. 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.
•6\. Non\-hypertensive or patient taking antihypertensive medication (except non\-permitted medication) maintained at a stable dosage at least for 2 months prior to screening (and the stable dosage can be maintained throughout the study).
•7\. Patient agrees to come to following visits inside the protocol specified range.
•In addition to the above criteria, these following inclusion criteria must be fulfilled according to B1 lab results:
•8\. HbA1c \= 7\.0% and \<9\.5%.

Exclusion Criteria

•Patients presenting with any of the following exclusion criteria will not be included in the trial:
•1\. Type I Diabetes Mellitus.
•2\. Patients who have one or more of the following: symptoms of poorly controlled diabetes (drastic weight loss, polyuria\-polydypsia) according to the investigator’s opinion, a history of diabetic ketoacidosis or hyperosmolar nonketosic coma.
•3\. Severe macular oedema requiring photocoagulation or specific treatment.
•4\. Known Heart Failure (Grade I to IV of NYHA classification).
•5\. Patients who had an acute cardiovascular episode within the 6 months previous to the start of the trial, or with a history of coronary angioplasty, history of stroke, TIA (Transient Ischemic Attack)], Coronary Heart Disease (Angina pectoris, history of myocardial infarction, revascularisation procedures)
•6\. Blood Pressure \> 160 / 95 mmHg.
•7\. Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, hepatic, neurological or psychiatric abnormalities or medical disease.
•8\. Patients who have serious or unstable medical or psychological conditions which, in the opinion of the Investigator, would lead the patient to be non\-compliant or uncooperative during the study or would compromise the patient’s safety or successful participation in the study
•9\. Known alcohol and/or any other drug abuse or dependence. Alcohol consumption of more than 3 alcoholic beverages per day is considered abusive. One alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer.