NCT01316861已完成3 期
A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus
EMS1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Glycosylated hemoglobin (HbA1c)
研究概览
简要总结
The Purpose of This Study is to Evaluate the Efficacy and Safety of Acarbose in Type 2 Diabetic Patients Using Two Different Formulations of Acarbose 50mg.
详细描述
Study Design:
- Multicenter
- Phase III
- Randomized
- Double Blind
- Prospective and Comparative
- Experiment duration: 105 days
- 5 visits
- Efficacy
- Adverse event
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to understand the study procedures agree to participate and give written consent.
- •Diagnosed with type 2 diabetes mellitus (t2dm)b
- •Female patients of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) which agree to use a medically accepted contraceptive regimen for the duration of the study.
排除标准
- •Pregnancy or risk of pregnancy.
- •Lactation
- •Any pathology or past medical condition that can interfere with this protocol
- •Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
- •Known hypersensitivity / intolerance to acarbose or any of its excipients
研究组 & 干预措施
EMS Acarbose
Experimental
干预措施: EMS Acarbose (Drug)
Bayer Acarbose
Active Comparator
干预措施: Bayer Acarbose (Drug)
结局指标
主要结局
Glycosylated hemoglobin (HbA1c)
时间窗: Change from baseline to day 98
次要结局
- Safety will be evaluated by the Adverse events occurence(Day 105)
- Decrease in mean Fasting Plasma Glucose (FPG)(Change from baseline to day 14, 28, 42, 70 and 98)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)Impaired Glucose ToleranceDiabetes MellitusCoronary Artery DiseaseNCT00858676Aichi Gakuin University150
已完成
2 期
Safety and Tolerability Study of MBX-2044 in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT00422487CymaBay Therapeutics, Inc.60
已完成
2 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT00605475Novartis231
已完成
4 期
Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM PatientsType 2 Diabetes MellitusNCT01490918The Catholic University of Korea165
已完成
1 期
Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & Relative Bioavailability of the Crystalline and Amorphous Forms of BMS-903452 [Panels 4, 6, 11 & 12(Part A)], and Subjects With Type 2 Diabetes Mellitus (Part B)DiabetesNCT01240980Bristol-Myers Squibb104