A Multi-center, phase3, Open-label Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Gemigliptin
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 主要终点
- Safety outcomes_ Change of heartbeat
研究概览
简要总结
The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period.
At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.
The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.
详细描述
The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. Throughout this period, subjects will receive concurrent administration of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day), and will have a washout period for other oral antidiabetic drugs.
At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.
The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with T2DM age 19 ~ under 80 years
- •Subjects who have 7% ≤ HbA1c ≤ 11% in screening visit(V1-1)
- •Subjects who have FPG <270 mg/dl screening visit(V1-1)
- •Subjects who have received a combination of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day) for a minimum of 8 weeks prior to Visit 2 (Enrollment Visit)
- •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 < 45 mL/min/1.73 m2
- •Severe heart failure (NYHA class III/IV
研究组 & 干预措施
Study group (DWP16001 0.3 mg)
DWP16001 0.3mg, Tablets, Orally, Once daily
干预措施: DWP16001 0.3 mg (Drug)
结局指标
主要结局
Safety outcomes_ Change of heartbeat
时间窗: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
Safety outcomes_ Change of heartbeat
Safety outcomes_ Change of body temperature
时间窗: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
Safety outcomes_ Change of body temperature
Safety outcomes_Adverse events occurred during clinical trials
时间窗: from baseline up to 52 weeks
Safety outcomes_Adverse events occurred during clinical trials
Safety outcomes_ Change of blood pressure
时间窗: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
Safety outcomes_ Change of blood pressure
Efficacy outcome_Change of HbA1c
时间窗: from Baseline at Week 8, 16, 24, 38, and 52 after administration of the IP
Efficacy outcome_Change of HbA1c
Efficacy outcome_Change of FPG
时间窗: from baseline at Week 8, 16, 24, 38, and 52 after administration of the IP
Efficacy outcome_Change of FPG
Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5%
时间窗: at Weeks 8, 16, 24, 38 and 52 after administration of the IP
Efficacy outcome_Proportion of subjects achieving HbA1c target of \< 6.5%
Efficacy outcome_Proportion of subjects achieving HbA1c target of < 7.0 %
时间窗: at Weeks 8, 16, 24, 38 and 52 after administration of the IP
Efficacy outcome_Proportion of subjects achieving HbA1c target of \< 6.5%
次要结局
未报告次要终点