NCT03641352Unknown3 期
The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes Inadequately Controlled With D150 Plus D759, Randomized, Double-blind, Multi-center, Parallel-group, Placebo Control, Therapeutic Confirmatory Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change from baseline in Glycosylated Hemoglobin
研究概览
简要总结
The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.
详细描述
The aim of this phase 3 study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patient with type 2 diabetes who were nao adequately controlled for blood glucose by the combination of D150 and D759
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
- Triple (Participant, Care Provider, Investigator)
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
- •between 19 years and 80 years old(male or female)
- •Type 2 diabetes mellitus
- •The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
- •BMI between 21kg/m2 and 40kg/m2
- •C-peptide ≥ 1.0 ng/ml
- •Agreement with written informed consent
- •HbA1c 7 to 10% after Run-in period
排除标准
- •Type 1 diabetes mellitus or secondary diabetes mellitus
- •Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
- •Treatment with Thiazolidinedione(TZD) within 3 months or patient who has experience such as hypersensitivity reaction, serious adverse event with TZD, Biguanide
- •Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
- •Treatment with anti-obesity drugs within 3 months
研究组 & 干预措施
CKD-501 0.5mg
Experimental
CKD-501 0.5mg
干预措施: CKD-501 0.5mg (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Glycosylated Hemoglobin
时间窗: Baseline, 24weeks
次要结局
- Change from baseline in Fasting plasma glucose(Baseline, 24weeks, 52weeks)
- Change from baseline in Total Cholesterol(Baseline, 24weeks, 52weeks)
- Change from baseline in QUICKI(Quantitative Insulin Check Index)(Baseline, 24 weeks, 52 weeks)
- Change from baseline in in Glycosylated Hemoglobin(Baseline, 52weekes)
- Evaluate safety of CKD-501 from number of participants with adverse events(Baseline, 24weeks, 52weeks)
- Change from baseline in LDL-Cholesterol(Baseline, 24 weeks, 52 weeks)
- Change from baseline in non-HDL-Cholesterol(Baseline, 24 weeks, 52 weeks)
- Change from baseline in HDL-Cholesterol(Baseline, 24 weeks, 52 weeks)
- HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%)(Baseline, 24weeks)
- Change from baseline in Triglycerides(Baseline, 24 weeks, 52 weeks)
- Change from baseline in Apo-B(Baseline, 24 weeks, 52 weeks)
- Change from baseline in Apo-CⅢ(Baseline, 24 weeks, 52 weeks)
- Change from baseline in Apo-AⅠ(Baseline, 24 weeks, 52 weeks)
- Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function)(Baseline, 24 weeks, 52 weeks)
- Change from baseline in Small Dense LDL-Cholesterol(Baseline, 24 weeks, 52 weeks)
- Change from baseline in FFA(Free Fatty Acid)(Baseline, 24 weeks, 52 weeks)
- Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)(Baseline, 24weeks, 52weeks)
研究者
研究点 (1)
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