Type II Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Cardiovascular Diseases, PPARs, OGTT
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.
Detailed 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.
Interventions
DRUGGFT505 80mg
hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast
DRUGPlacebo
hard gelatin capsules,oral administration,4 capsules per day before breakfast
Sponsors
Genfit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 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
| Measure | Time frame | Description |
|---|---|---|
| Oral Glucose Tolerance Test (OGTT) | 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. |
| Fasting Plasma Glucose | 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). |
| Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)] | 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). |
Countries
Bosnia and Herzegovina, Latvia, Moldova, North Macedonia, Romania, Serbia
Outcome results
None listed