NCT02126358已完成3 期
A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of the Fix-dose Combination Therapy With Gemigliptin 50mg and Rosuvastatin 20mg With Type 2 Diabetes and Dyslipidemia
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- HbA1c change
研究概览
简要总结
To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia
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)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus with Dyslipidemia
- •Adults who are at least 19 years old
排除标准
- •Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
- •Patients with gestational diabetes or secondary diabetes
- •Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment
- •Patients with thyroid gland dysfunction deviating from the normal TSH range
- •Patients with pituitary insufficiency or adrenal insufficiency
研究组 & 干预措施
Gemigliptin
Placebo Comparator
only Gemiglitpin (Gemiglitpin/Rosuvastatin FDC:Placebo , Rosuvastatin :Placebo)
干预措施: Gemigliptin and/or Rosuvastatin (Drug)
Rosuvastatin
Placebo Comparator
only Rosuvastatin (Gemiglitpin/Rosuvastatin FDC:Placebo , gemigliptin :Placebo)
干预措施: Gemigliptin and/or Rosuvastatin (Drug)
FDC
Experimental
Gemigliptin & Rosuvastatin (Gemiglitpin only:Placebo ,Rosuvastatin only:Placebo)
干预措施: Gemigliptin and/or Rosuvastatin (Drug)
结局指标
主要结局
HbA1c change
时间窗: Baseline(Day 0) to Treatment (last visit, w24)
LDL-C change rate
时间窗: Baseline(Day 0) to Treatment (last visit, w24)
次要结局
- HbA1c(Baseline(Day 0) to Treatment (last visit, w24))
- LDL-C change rate(Baseline(Day 0) to Treatment (last visit, w24))
研究者
研究点 (1)
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