NCT05376930已完成3 期
A Multi-center, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy 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 63 人开始时间: 2021年9月16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
- 63
- 试验地点
- 1
- 主要终点
- Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
研究概览
简要总结
The purpose of this study is evaluate the long term safety and efficacy 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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participated in the prior phase 3 study (Protocol No: DW_DWP16001301) for meeting the inclusion criteria and completed the study
- •Voluntarily decided to participate in the extension study and provided a written consent on the consent form
排除标准
- •Those who dropped out of the previously conducted phase 3 clinical trial (Protocol No: DW_DWP16001301)
- •Pregnant or lactating women or those who do not consent to the use of appropriate contraceptive methods during clinical trials Appropriate method of birth control for you or your partner: You must agree to one of the following
- •Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or
- •A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or
- •Use of male condom combined with either cervical cap or diaphragm
- •In case the investigator judges that participation in this extended clinical trial is inappropriate in consideration of the 24-week observation progress in the previously conducted phase 3 clinical trial (Protocol No: DW_DWP16001301)
研究组 & 干预措施
DWP16001
Experimental
DWP16001 Tablets
干预措施: DWP16001 Amg (Drug)
结局指标
主要结局
Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
时间窗: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
\*Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria
次要结局
- Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP(at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP)
- Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP(at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP)
- Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP(at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP)
研究者
研究点 (1)
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