A Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of JTT-851 in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 325
- 主要终点
- Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851
研究概览
简要总结
The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.
详细描述
This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.
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
- Quadruple (Participant, Care Provider, 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
- •Males and females with type 2 diabetes, 18-70 years of age at Visit 1
- •Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)
- •Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment
- •Body mass index (BMI) ≥ 23.0 kg/m^2 and ≤ 45.0 kg/m^2 at Visit 1
排除标准
- •Females who are pregnant or breast-feeding
- •Known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy
- •Acute coronary syndrome or uncontrolled hypertension
- •Does not meet all diet or previous/concomitant medication restriction criteria
研究组 & 干预措施
JTT-851 Dose 1
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
干预措施: JTT-851 (Drug)
JTT-851 Dose 1
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
干预措施: Placebo for comparator (Drug)
JTT-851 Dose 2
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
干预措施: JTT-851 (Drug)
JTT-851 Dose 2
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
干预措施: Placebo for comparator (Drug)
JTT-851 Dose 3
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
干预措施: JTT-851 (Drug)
JTT-851 Dose 3
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
干预措施: Placebo for comparator (Drug)
Glimepiride Dose 1
Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks
干预措施: Glimepiride (Drug)
Glimepiride Dose 1
Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks
干预措施: Placebo for Active (Drug)
Placebo active & Placebo comparator
Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks
干预措施: Placebo for Active (Drug)
Placebo active & Placebo comparator
Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks
干预措施: Placebo for comparator (Drug)
结局指标
主要结局
Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851
时间窗: 12 weeks
To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks
次要结局
- Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo(12 weeks)
- Effect on ancillary efficacy measures(12 weeks)
- Pharmacokinetics of JTT-851 and its metabolites(12 weeks)