NCT04014023Unknown2 期
A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2019年7月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 to 80 years
- •Patients who was diagnosed with type 2 diabetes mellitus at least 8 weeks before
- •Body Mass Index (BMI) between 20 and 45 kg/㎡
- •Patients with 7% ≤ HbA1c ≤ 10% at screening
- •Subject who has conducted a stable diet and exercise for at least 8 weeks
排除标准
- •Type 1 diabetes mellitus or secondary diabetes
- •Severe diabetes complications (proliferative diabetic retinopathy, stage 4 or higher nephropathy or severe diabetic neuropathy, diabetic ketoacidosis)
- •Clinical significantly renal disorders
- •Creatinine clearance < 60ml/min (0.84ml/s/㎡) or Glomerular filtration rate(eGFR) < 60mL/min/1.73
- •Severe gastrointestinal disorder
- •Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg)
- •History of Acute coronary syndrome, unstable angina, myocardial infarction requiring hospitalization, stroke, transient ischemic attack, severe heart failure (NYHA class III/IV), or heart arrhythmia
研究组 & 干预措施
DWP16001 Amg
Experimental
DWP16001 Amg, Tablets, Orally, Once daily
干预措施: DWP16001 (Drug)
DWP16001 Amg
Experimental
DWP16001 Amg, Tablets, Orally, Once daily
干预措施: Placebo (Drug)
DWP16001 Bmg
Experimental
DWP16001 Bmg, Tablets, Orally, Once daily
干预措施: DWP16001 (Drug)
DWP16001 Bmg
Experimental
DWP16001 Bmg, Tablets, Orally, Once daily
干预措施: Placebo (Drug)
DWP16001 Cmg
Experimental
DWP16001 Cmg, Tablets, Orally, Once daily
干预措施: DWP16001 (Drug)
DWP16001 Cmg
Experimental
DWP16001 Cmg, Tablets, Orally, Once daily
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Placebo, Tablets, Orally, Once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: at 12 weeks
次要结局
- Change from baseline in FPG(at week 4, 8, 12)
- The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline(at week 4, 8, 12)
研究者
研究点 (1)
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