A Phase IIIb, Multicenter, Multinational, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Glycemic and Renal Efficacy of Once Daily Administration of Linagliptin 5 mg for 24 Weeks in Type 2 Diabetes Patients, With Micro- or Macroalbuminuria (30-3000mg/g Creatinine) on Top of Current Treatment With Angiotensin ConvEnzyme Inhibitor or Angiotensin Receptor Blocker - MARLINA (Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
研究概览
简要总结
Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
linagliptin 5mg
linagliptin 5 mg once daily
干预措施: Linagliptin 5mg (Drug)
placebo
matching placebo for linagliptin dose once daily
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
时间窗: Baseline and 24 weeks
Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double- blind trial medication. The term "baseline" refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest.
次要结局
- The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment(Baseline and 24 weeks)
- The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment(Baseline and 24 weeks)