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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Genfit
- 入组人数
- 97
- 试验地点
- 28
- 主要终点
- HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
GFT505 80mg
干预措施: GFT505 80mg (Drug)
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c
时间窗: 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).
次要结局
- 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)