Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 178
- 主要终点
- Change From Baseline in HbA1c
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who has been receiving dietary therapy and a stable dose and regimen of insulin over 8 weeks before at the time of an observation term start
- •Patients whose HbA1c at the time of an observation term start is 7.5% or more and less than 10.0%
排除标准
- •Type 1 Diabetes Mellitus
- •Patients with serious diabetic complications and other serious complications
研究组 & 干预措施
KAD-1229/KAD-1229
Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study.
干预措施: KAD-1229 (Drug)
KAD-1229/KAD-1229
Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study.
干预措施: Insulin (Drug)
Placebo/KAD-1229
Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study.
干预措施: KAD-1229 (Drug)
Placebo/KAD-1229
Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study.
干预措施: Placebo (Drug)
Placebo/KAD-1229
Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study.
干预措施: Insulin (Drug)
结局指标
主要结局
Change From Baseline in HbA1c
时间窗: 16 weeks
次要结局
未报告次要终点