NCT04632862已完成3 期
A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 3, 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 140 人开始时间: 2020年11月11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
- 140
- 试验地点
- 1
- 主要终点
- HbA1c level at Week 24 after administration 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 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
- 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 ≤ 10% who have been diagnosed with T2DM at least 8 weeks
- •Subjects with BMI of 20-45 kg/m2
- •Subjects who have been on a stable diet and exercise program for at least 8 weeks
- •Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study
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
Experimental
DWP16001 Amg, Tablets, Orally, Once daily
干预措施: DWP16001 (Drug)
DWP16001 Amg Placebo
Placebo Comparator
DWP16001 Amg Placebo, Tablets, Orally, Once daily
干预措施: DWP16001 (Drug)
结局指标
主要结局
HbA1c level at Week 24 after administration of the IP
时间窗: at Week 24
1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP
次要结局
- HbA1c level at Weeks 6, 12, and 18 after administration of the IP(at weeks 6, 12, and 18)
- HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP(at weeks 6, 12, 18, and 24)
- FPG level 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)
Loading locations...
相似试验
Unknown
2 期
Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes MellitusT2DM (Type 2 Diabetes Mellitus)NCT04014023Daewoong Pharmaceutical Co. LTD.196
招募中
3 期
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease (NERD)Non-Erosive Gastro-Esophageal Reflux DiseaseNon-Erosive Esophageal Reflux DiseaseNon-erosive Reflux DiseaseNCT06121830Daewoong Pharmaceutical Co. LTD.324
已完成
3 期
The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes MellitusT2DM (Type 2 Diabetes Mellitus)NCT04654390Daewoong Pharmaceutical Co. LTD.270
Unknown
3 期
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non Erosive Reflux DiseaseNon-Erosive Gastroesophageal Reflux DiseaseNCT03811080Daewoong Pharmaceutical Co. LTD.327
进行中（未招募）
3 期
The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on MetforminGlucose Metabolism DisordersMetabolic DiseaseEndocrine System DiseasesDiabetes MellitusDiabetes Mellitus, Type 2NCT05505994Daewoong Pharmaceutical Co. LTD.340