Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.
详细描述
This is a phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.
In YH14755 treatment group, 88 subjects will be assigned and the subjects administer YH14755 for 16 weeks.
In Metformin treatment group, 88 subjects will be assigned and the subjects administer Metformin for 16 weeks.
In Rosuvastatin treatment group, 88 subjects will be assigned and the subjects administer Rosuvastatin for 16 weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Subjects with Dyslipidemia and Type II Diabetes
- •6.5% ≤ HbA1c level ≤ 9.0% and LDL-C level ≤ 250mg/dL(6.5 nmal/L) at screening
- •BMI ≤ 45kg/m2
- •Subjects who dose not administered diabetes treatment at least 4 weeks prior to screening visit.
- •19 years later, men and women under the age of 75
排除标准
- •Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
- •Subject with type I Diabetes
- •Subject with hypertension which does not controlled by treatment(have blood pressure > 160/110mmHg)
- •Have a known allergy to drugs
- •Have administered Cyclosporine
- •Have administered Obesity treatment within 12 weeks prior to screening visit
- •Participated in any other clinical trials within 30 days prior to the first administration
- •Subject who is judged to be ineligible by investigator
研究组 & 干预措施
YH14755
PO, Once Daily, 16 weeks
干预措施: YH14755 (Drug)
Metformin
PO, Once Daily, 16 weeks
干预措施: Metformin (Drug)
Rosuvastatin
PO, Once Daily, 16 weeks
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Change from baseline at 16 weeks
Change in LDL Cholesterol
时间窗: Change from baseline at 16 weeks
次要结局
未报告次要终点