A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study and Open-Label Extension Study to Evaluate the Efficacy and Safety of DWP16001 Add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
详细描述
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Part 1: Double-blind Part 2: Open label
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with T2DM aged 18 to 80 years
- •Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%
- •Subjects with BMI of 20-45 kg/m2
- •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
- •Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
- •Diabetic ketoacidosis, diabetic coma or precoma within the past year
- •Urinary tract infections or genital infections within
- •Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
- •eGFR < 60 mL/min/1.73 m2
- •Severe heart failure (NYHA class III/IV)
研究组 & 干预措施
Study group
DWP16001 A mg, Dapagliflozin placebo
干预措施: DWP16001 (Drug)
Study group
DWP16001 A mg, Dapagliflozin placebo
干预措施: Dapagliflozin Placebo (Drug)
Control group
DWP16001 A mg placebo, Dapagliflozin
干预措施: Dapagliflozin (Drug)
Control group
DWP16001 A mg placebo, Dapagliflozin
干预措施: DWP16001 Placebo (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: at 24 weeks
Change in HbA1c (%) is assessed with the values measured at the central laboratory
次要结局
未报告次要终点