NCT01968044已完成3 期
A Multicenter,Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase IIIb Study to Evaluate the Safety and Efficacy After 12 Weeks Administration of Gemigliptin and Placebo in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment With an Additional 40 Weeks, Double-blind,Active-controlled, Double-dummy,Long-term Extension Study
LG Life Sciences0 个研究点目标入组 132 人开始时间: 2013年10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
- 132
- 主要终点
- HbA1c change
研究概览
简要总结
Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term peirod (52 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
- •Patients with Type 2 Diabetes Mellitus
- •Patients with moderate or severe renal insufficiency
- •All patients give written informed consent
排除标准
- •Has type 1 diabetes mellitus or a history of ketoacidosis
- •Is on dialysis or is likely to need dialysis during the study
- •Has active liver disease
研究组 & 干预措施
Gemigliptin
Experimental
Participant will remain gemigliptin 50mg throughout entire study (52 weeks).
干预措施: Gemigliptin (Drug)
Placebo to linagliptin
Other
Participant who is randomized to placebo will be switched to linagliptin after 12 week and administered linagliptin by week 52.
干预措施: Placebo to Linagliptin (Drug)
结局指标
主要结局
HbA1c change
时间窗: HbA1c change from baseline to week 12
次要结局
- HbA1c Change(HbA1c change from baselint to week 6, 52)
- FPG(FPG change from baseline to week 6,12,52)
- Glycated albumin(Glycated albumin change from baseline to week 6,12,52)
- Fructosamin(Fructosamin change from baseline to week 6,12,52)
- Waist(Waist change from baseline to week 12,52)
- HbA1c responser (HbA1c<7.0%)(HbA1c responser rate at week 12,52)
- Fasting serum C-peptide(Fasting serum C-peptide change from baseline to week 12,52)
- Fasting Lipid parameters(Fasting Lipid parameters change from baseline to week 12,52)
- Albuminuria(Albuminuria change from baseline to week 12,52)
研究者
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