NCT01407003已完成1 期
A Randomized, Double-blind, Placebo-controlled, 4-part, Interwoven Single- and Multiple-ascending Dose Study to Assess Safety, Tolerability, PK and PD of LIK066 in Healthy Subjects and in Patients With T2DM
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single and multiple dose(s) of LIK066: number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).
研究概览
简要总结
This study will assess safety, tolerability, and effect of LIK066 on blood glucose in healthy subjects and in patients with T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parts I and III: Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
- •Parts II and IV: Patients, age 18-65 years, must have been diagnosed with T2DM at least 8 weeks prior to screening with HbA1c 6.5 to 10.0%, inclusive, at screening.
- •Fasting plasma glucose ≤250mg/dL at screening and baseline.
- •If treated with metformin, patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.
- •Exclusion Criteria; all parts:
- •Patients with type 1 diabetes mellitus.
- •Patients with history of acute diabetic complications within the 6 months prior to screening.
- •Women of child-bearing potential.
- •Patients with signs or symptoms of significant diabetic complications.
- •Patients treated with certain blood pressure or lipid lowering medications unless patients have been on stable doses for the 12 weeks prior to dosing.
- •History of drug or alcohol abuse within the 12 months prior to dosing.
- •Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
LIK066 in healthy subjects
Experimental
干预措施: LIK066 (Drug)
Matching placebo in healthy subjects
Placebo Comparator
干预措施: Placebo (Drug)
LIK066 in patients with type 2 diabetes mellitus
Experimental
干预措施: LIK066 (Drug)
Matching placebo in patients with type 2 diabetes mellitus
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of single and multiple dose(s) of LIK066: number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).
时间窗: Daily during treatment
次要结局
- Change in fasting and post-challenge plasma glucose after a single dose and 2 weeks of treatment(Baseline and End of Treatment)
- Pharmacokinetics: to measure the study drug concentration in blood and urine samples to be collected after drug administration(Day 1 and End of Treatment)
- Change in fasting and post-challenge plasma glucose after 2 weeks of treatment(Baseline and End of Treatment)
研究者
研究点 (1)
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