NCT01951183撤回2 期
A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2A STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-DAILY RO6811135 IN TYPE 2 DIABETIC PATIENTS INADEQUATELY CONTROLLED WITH METFORMIN
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients treated with a stable dose of metformin.
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
- •Adults between the age of 18 and 65
- •Have been diagnosed with diabetes for at least 3 months and treated with a stable dose of metformin for at least 8 weeks
- •Hemoglobin A1c between 7.2 and 10.5%
- •Fasting plasma glucose less than 250 mg/dL
- •C-peptide greater than 1.5 ng/mL
- •Body mass index (BMI) between 27 and 44
排除标准
- •Pregnant or lactating women
- •Type 1 diabetes
- •Had undergone weight loss surgery or weight loss procedure involving the gastrointestinal tract, such as gastric bypass, gastric stapling, or gastric banding
- •Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
- •Significant kidney or liver disease as determined by the investigator
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
Change from baseline in HbA1c
时间窗: from baseline to Week 12
次要结局
- Pharmacokinetics: Area under the concentration-time curve (AUC)(12 weeks)
- Change from baseline in fasting plasma glucose (FPG)(from baseline to Week 12)
- Safety: Incidence of adverse events(19 weeks)
研究者
相似试验
已完成
2 期
ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant TreatmentMajor Depressive DisorderNCT01457677Hoffmann-La Roche357
已完成
3 期
A Study of Gantenerumab in Participants With Prodromal Alzheimer's DiseaseAlzheimer's DiseaseNCT01224106Hoffmann-La Roche799
已完成
2 期
A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS)Down SyndromeNCT02024789Hoffmann-La Roche173
终止
3 期
A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing SpondylitisAnkylosing SpondylitisNCT02685904Mycenax Biotech Inc.10
终止
2 期
Study of RO6807952 in Patients With Diabetes Mellitus Type 2Diabetes Mellitus Type 2NCT01516476Hoffmann-La Roche2