NCT00458016已完成2 期
A Phase 2, 28-day, Multicenter, Double-Blind,Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of MB07803 in Patients 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
- 105
- 主要终点
- Fasting Plasma Glucose Concentration
研究概览
简要总结
The purpose of this study is to collect important information regarding the safety, tolerability, and efficacy of MB07803 when administered for 28 days in patients 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting plasma glucose between 120 - 270 mg/dL at screening
- •HbA1c measurements between 6.0 - 10% at screening
- •Females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). Females who are postmenopausal for at least 12 consecutive months and documented by blood follicular stimulating hormone (FSH) greater than or equal to 40 mlU/mL.Females of childbearing potential must be willing to use an approved double-barrier method of birth control (e.g. condom plus spermicide ;IUD plus spermicide) from the time of signing the informed consent form through 4 weeks following the last dose of study drug.
- •Body mass index (BMI) in the range of 18.5 - 37 kg/m2 Patients with a BMI in the range of 37.5 - 40 kg/m2 who in the Investigator's opinion, are in good health and satisfy the eligibility criteria, will be considered on a case-by case basis
- •Written informed consent
排除标准
- •Type 1 diabetes mellitus
- •Type 2 diabetes mellitus with a history of diabetic ketoacidosis or ketosis-prone
- •Use of thiazolidinediones (TZDs)
- •Currently on more than two oral hypoglycemic agent
- •History of outpatient insulin use
- •Clinically significant history of cardiac disease within 6 months of informed consent
研究组 & 干预措施
1
Experimental
干预措施: MB07803 (Drug)
2
Experimental
干预措施: MB07803 (Drug)
3
Experimental
干预措施: MB07803 (Drug)
4
Experimental
干预措施: MB07803 (Drug)
5
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Fasting Plasma Glucose Concentration
时间窗: Change from baseline to Day 28
次要结局
- Fasting serum triglycerides and free fatty acids, fasting serum insulin.(Change from baseline to Day 28)
研究者
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