NCT05376969已完成3 期
A Multi-center, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2021年5月25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
- 159
- 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
A Multi-center, Open-label, Extension study to Evaluate the long term Safety and Efficacy of DWP16001 add-on to metformin in Patients with type 2 diabetes mellitus inadequately controlled on metformin
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_DWP16001302) 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
- •Withdrawn from the prior phase 3 study (Protocol No: DW_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator
- •Subjects with the following diseases or signs:
- •Diabetic ketoacidosis
- •Moderate to severe renal impairment (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m2
- •Females who are pregnant or breast-feeding, or subjects who do not agree to the use of appropriate contraceptive methods throughout the study
- •Subjects must agree to one of the following appropriate contraceptive methods for subjects or their partners:
- •① Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or
- •② A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or
- •③ Use of male condom combined with either cervical cap or diaphragm Determined to be ineligible for the study by the investigator, besides the above
研究组 & 干预措施
DWP16001 Amg
Experimental
DWP16001 Amg, Tablets, Orally, Once daily
干预措施: DWP16001 (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
- 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)
- 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)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Study to Evaluate the Long Term Safety and Efficacy of DWP16001 Compared to Placebo in the Treatment of T2DM.T2DM (Type 2 Diabetes Mellitus)NCT05376930Daewoong Pharmaceutical Co. LTD.63
已完成
3 期
An Extension Study of WA19926 of the Long-Term Safety of Tocilizumab (RoActemra/Actemra) in Patients With Early Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisNCT01664598Hoffmann-La Roche49
已完成
3 期
Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced MalignanciesNCT04164199BeOne Medicines404
终止
1 期
A Study to Evaluate the Long-Term Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)MPS IV AMucopolysaccharidosis IVAMorquio A SyndromeNCT01242111BioMarin Pharmaceutical20
已完成
3 期
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular EdemaDiabetic Macular EdemaNCT04432831Hoffmann-La Roche1,479