NCT07076056已完成3 期
A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- % change of HbA1c
研究概览
简要总结
A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with Type2 Diabetes
- •19 ≤ Age ≤ 85
- •7.0% ≤ HbA1c ≤ 10.5%
排除标准
- •Patients with a history of acute pancreatitis
- •Patients with a history of pre-diabetic coma
- •Patients with a history of diagnosis of malignant tumors within 5 years prior to visit 1
研究组 & 干预措施
DW1026C1 & DW1026C2 placebo & DW1026S placebo
Experimental
干预措施: DW1026C1 (Drug)
DW1026C1 placebo & DW1026C2 & DW1026S placebo
Experimental
干预措施: DW1026C2 (Drug)
DW1026C1 placebo & DW1026C2 placebo & DW1026S
Placebo Comparator
干预措施: DW1026S (Drug)
结局指标
主要结局
% change of HbA1c
时间窗: 24 weeks
% change of HbA1c in week 24 from baseline
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain of the ShoulderTendonitisShoulder PainBursitisNCT01506154MEDRx USA, Inc.210
已完成
3 期
MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the ShoulderAcute TendonitisBursitisNCT01161615MEDRx USA, Inc.350
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and DapagliflozinType2 DiabetesNCT04885712Boryung Pharmaceutical Co., Ltd378
招募中
3 期
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)Sickle Cell DiseaseNCT06439082Novartis Pharmaceuticals354
终止
3 期
Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 InfectionSARS-CoV-2 InfectionNCT05109611Sanotize Research and Development corp.1,389