NCT01044017已完成1 期
A Single-center, Double-blind, Randomized, Cross-over, Placebo-controlled, Single-dose Study to Investigate Glycemic Parameters of Efficacy During 24 Hours, Safety/ Tolerability and Pharmacokinetics of Two Dose Levels of RO4998452 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
- 22
- 主要终点
- Effect on postprandial plasma glucose concentration
研究概览
简要总结
This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is <50.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18-75 years of age
- •Type 2 diabetes mellitus, diagnosed for at least 3 months at screening
- •Treatment with diet and exercise
- •BMI between 27 and 40 kg/m2
排除标准
- •Type 1 diabetes
- •History of ketoacidosis, hyperosmolar coma, or lactic acidosis
- •Renal disease or renal dysfunction
- •Evidence of significant diabetic complication
- •Currently or within 3 months prior to screening treated with any oral or injectable anti-diabetic agents (exception: insulin injection in emergency situation)
- •History of anti-diabetic triple therapy
研究组 & 干预措施
A
Experimental
干预措施: RO4998452 (Drug)
B
Experimental
干预措施: RO4998452 (Drug)
C
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Effect on postprandial plasma glucose concentration
时间窗: Following meal 13 hours after dosing
次要结局
- Mean postprandial daily plasma glucose concentration (3 consecutive meals)(25 hours)
- Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration(Assessments up to 25 hours after dosing)
- Safety and tolerability: AEs, laboratory parameters(AEs throughout study, laboratory assessments on 3 treatment days and on follow-up)
- Urinary glucose excretion(Assessments up to 25 hours after dosing)
研究者
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