NCT01789788已完成1 期
A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6811135 in Patients With Type 2 Diabetes Mellitus.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the last dose of study drug.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18 to 65 years of age, inclusive
- •Type 2 diabetes mellitus according to WHO criteria diagnosed for at least 3 months prior to screening
- •On stable dose of metformin for at least 2 months prior to screening
- •Fasting plasma glucose during the screening period </= 240 mg/dL
- •Hemoglobin A1c (HbA1c) levels at screening >/= 6.5% and </= 10.5%
- •Evidence of insulin secretory capacity at screening
- •Body mass index (BMI) 27 to 42 kg/m2, inclusive
- •Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
排除标准
- •Type 1 diabetes
- •Acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
- •History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
- •Evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator
- •History of severe symptomatic hypoglycemia (requiring assistances of a third party) within 6 months prior to screening
- •History or presence of clinically significant concomitant disease or disorder
- •Hemoglobin level below the lower limit of reference range at screening
- •Pregnant or lactating women
- •History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
RO6811135
Experimental
干预措施: RO6811135 (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: approximately 5 months
次要结局
- Pharmacokinetics: Area under the concentration-time curve (AUC)(Day 1 and Day 14)
- Pharmacodynamics of RO681135: Blood analysis(14 days)
研究者
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