NCT00962065已完成2 期
A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX4211 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
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control in subjects with type 2 diabetes mellitus.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Males and females (non-childbearing potential), aged 18-65 years
- •Diagnosis of Type 2 diabetes mellitus for at least 6 months prior to screening
- •Fasting plasma glucose ≤ 240 mg/dL prior to metformin washout
- •Body mass index < 42 kg/m^2
- •HbA1c value of 7 to 11%
- •C-peptide ≥ 1.0 ng/mL
- •Ability to provide written informed consent
排除标准
- •History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia
- •Use of any blood glucose lowering agent other than metformin
- •Prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
- •Laboratory or electrocardiogram abnormalities deemed significant by the Sponsor or the Investigator
- •Positive test result for glutamic acid decarboxylase (GAD) antibody
- •Surgery within 6 months of screening
- •Exposure to any investigational agent or participation in any investigational trial within 30 days prior to Day 1
- •Hypersensitivity to an SGLT2 inhibitor
- •History of drug or alcohol abuse within the last 12 months
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo dosing with daily oral intake for 28 days
干预措施: Placebo (Drug)
Low Dose
Experimental
A low dose of LX4211; daily oral intake for 28 days
干预措施: LX4211 Low Dose (Drug)
High Dose
Experimental
A high dose of LX4211; daily oral intake for 28 days
干预措施: LX4211 High Dose (Drug)
结局指标
主要结局
Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion
时间窗: Baseline to Day 28
To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.
次要结局
- Change From Baseline at Day 29 in Fasting Plasma Glucose(Baseline to Day 29)
- Change From Baseline at Day 28 in Plasma HbA1c(Baseline to Day 28)
- Change From Baseline at Day 28 in Plasma Fructosamine Level(Baseline to Day 28)
- Change From Baseline at Day 28 in Mean Arterial Pressure(Baseline to Day 28)
- Change From Baseline at Day 28 in Triglycerides(Baseline to Day 28)
研究者
研究点 (1)
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