NCT01413204已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TA-7284 as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 5
- 主要终点
- Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.
详细描述
This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women age ≥20 years old
- •Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period
- •HbA1c of ≥7.0% and ≤10.0%
排除标准
- •Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
- •Past or current history of severe diabetic complications
- •Fasting plasma glucose > 270 mg/dL before treatment start
- •History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Patients requiring insulin therapy
研究组 & 干预措施
TA-7284 Low
Experimental
干预措施: TA-7284 Low (Drug)
TA-7284 High
Experimental
干预措施: TA-7284 High (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)
时间窗: baseline and 24 weeks
次要结局
- Change in Fasting Plasma Glucose(Week 24)
- Change in Body Weight(Week 24)
- Change in Blood Pressure(Week 24)
- Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs(Week 24)
- Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test(Week 24)
研究者
研究点 (5)
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