NCT01951235已完成2 期
A Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Mellitus.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Poxel SA
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus placebo. The study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione.
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
- •Subject has given written informed consent
- •Male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy.
- •Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m²
- •HbA1c criteria: ≥ 7% and ≤ 9.5%
- •Creatinine clearance ≥ 50 mL/[min*1.73 m2] at Screening Visit
- •Effective contraception for women of child bearing potential
排除标准
- •Any disease which in the investigator's opinion would exclude the subject from the study
- •Acute cardiovascular event within 3 months before randomization
- •Uncontrolled high blood pressure
- •Impairment of hepatic function
- •History of drug-induced Torsades de Pointes or a marked baseline prolongation of the QTc interval
- •Pregnancy or lactation
- •Use of any non-permitted medication
- •Positive screen for viral hepatitis
研究组 & 干预措施
Imeglimin (Dose 2)
Experimental
干预措施: Imeglimin (Drug)
Imeglimin (Dose 1)
Experimental
干预措施: Imeglimin (Drug)
Imeglimin (Dose 3)
Experimental
干预措施: Imeglimin (Drug)
Imeglimin (Dose 4)
Experimental
干预措施: Imeglimin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Baseline and week 24
次要结局
- Safety will be assessed by the incidence of adverse events (AEs), physical examination, relevant changes on laboratory tests, vital signs, and 12-lead electrocardiograms (ECG)(Baseline to week 24)
研究者
研究点 (1)
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