NCT04654390已完成3 期
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase3, Therapeutic Confirmatory 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 270 人开始时间: 2020年12月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation of the IP
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of DWP16001 compared to active drug 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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 to 80 years
- •Subjects with 7% ≤ HbA1c ≤ 11% at Screening
- •Subjects with BMI of 20-45 kg/m2
排除标准
- •Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria)
- •Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention
- •Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy)
- •eGFR < 60 mL/min/1.73 m2
- •Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.
- •Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg)
研究组 & 干预措施
DWP16001 Amg, Dapagiflozin Bmg placebo
Experimental
Tablets, Orally, Once daily
干预措施: DWP16001 Amg (Drug)
DWP16001 Amg placebo, Dapagliflozin Bmg
Active Comparator
Tablets, Orally, Once daily
干预措施: DWP16001 Amg (Drug)
结局指标
主要结局
Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation of the IP
时间窗: at Week 24
HbA1c level at Week 24 after administration of the IP
次要结局
- Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP(at weeks 6, 12, 18, and 24)
- Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP(at weeks 6, 12, and 18)
- Proportions of subjects who achieved HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP(at weeks 6, 12, 18, and 24)
研究者
研究点 (1)
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