NCT01358929已完成1 期
A Randomized, Placebo-Controlled, Sequential, Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MAR701/RO6807952 in Type 2 Diabetic Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is 8 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
- Double (Participant, Investigator)
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
- •Adult patients, 18 to 70 years of age, inclusive
- •Diagnosis of type 2 diabetes >/=3 months and </=10 years prior to screening
- •Fasting plasma glucose >/=110 mg/dL and </=240 mg/dL
- •Patients on a stable dose of metformin for at least 2 months prior to screening
- •Hemoglobin HbA1c >/=6.5% and </=10.5%
- •Body mass index >/=25 kg/m2 and </=42 kg/m2
- •Systolic blood pressure <155 mmHg and diastolic blood pressure <95 mmHg
排除标准
- •Patients with type 1 diabetes
- •History of significant renal and hepatic diseases
- •History of metabolic acidosis and diabetic gastroparesis
- •History of pancreatitis
- •History of coagulation disorders or unexplained excessive bleeding
- •History of clinically significant cardiovascular disease or severe symptomatic hypoglycemia within 6 months of screening
研究组 & 干预措施
1
Experimental
干预措施: RO6807952 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: 8 weeks
次要结局
- Blood concentrations of RO6807952(8 weeks)
- Effect of RO6807952 on Hemoglobin HbA1c level(8 weeks)
- Effect of RO6807952 on glucose level(8 weeks)
- Change in meal tolerance test(8 weeks)
研究者
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