NCT01376557已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of LX4211 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy
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
- 299
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c to Week 12
研究概览
简要总结
This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.
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
- •Adult subjects between the ages of 18 to 75 years, inclusive
- •Confirmed diagnosis of Type 2 diabetes mellitus
- •Meet required laboratory values at screening, including fasting plasma glucose less than 270 mg/dL
- •Stable dose of metformin monotherapy greater than 1500 mg/day for at least 8 weeks
- •Willing and able to provide written informed consent
- •Willing and able to maintain consistent dietary, physical activity, and sleeping patterns throughout the study
排除标准
- •History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
- •History of renal disease or clinically significant abnormal kidney function tests
- •Presence of active hepatic disease or clinically significant abnormal liver function tests
- •Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day 1
- •History of clinically significant cardiac arrhythmias within one year of study Day 1
- •Subjects with congestive heart failure
- •Subjects with uncontrolled Stage III hypertension
- •Triglycerides >1000 mg/dL at Screening
- •Known history of HIV or hepatitis C
- •History of illicit drug or alcohol abuse with one year of study Day 1
- •Have had 2 or more emergency room visits, doctor visits, or hospitalizations due to hypoglycemia within 6 months of study Day 1
- •Use of any other investigational drug within 30 days of study Day 1
- •Prior exposure to LX4211
- •Use of any medication or herbal supplement for the purpose of weight loss
- •Chronic use of any antidiabetic therapy other than metformin in the 3 months prior to study Day 1
- •Use of corticosteroids within 2 weeks prior to study Day 1
- •Major surgery within 6 months of study Day 1
- •Subjects with any history of severe gastroparesis
- •Inability or difficulty swallowing whole capsules or tablets
- •Women who are pregnant or breast feeding
研究组 & 干预措施
Treatment A
Experimental
干预措施: 75 mg LX4211 (Drug)
Treatment B
Experimental
干预措施: 200 mg LX4211 (Drug)
Treatment C
Experimental
干预措施: 400 mg LX4211 (Drug)
Treatment D
Experimental
干预措施: 200 mg LX4211 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in HbA1c to Week 12
时间窗: 12 weeks
次要结局
- Number of Participants Achieving a HbA1c Value of <7% at Week 12(12 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12(12 weeks)
- Change From Baseline in Body Weight at Week 12(12 weeks)
- Change From Baseline in Systolic Blood Pressure (SPB) at Week 12(12 weeks)
- Change From Baseline in Triglycerides at Week 12(12 weeks)
研究者
研究点 (1)
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