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临床试验/NCT01422876
NCT01422876已完成3 期

A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Boehringer Ingelheim211 个研究点 分布在 1 个国家目标入组 1,405 人开始时间: 2011年8月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
1,405
试验地点
211
主要终点
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

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 —（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

BI 10773/linagliptin FDC (high dose)

Experimental

Patients receive BI 10773/linagliptin FDC (high dose) once daily

干预措施: high dose FDC (Drug)

BI 10773/linagliptin FDC (high dose)

Experimental

Patients receive BI 10773/linagliptin FDC (high dose) once daily

干预措施: low dose FDC placebo (Drug)

BI 10773/linagliptin FDC (high dose)

Experimental

Patients receive BI 10773/linagliptin FDC (high dose) once daily

干预措施: high dose BI 10773 placebo (Drug)

BI 10773/linagliptin FDC (high dose)

Experimental

Patients receive BI 10773/linagliptin FDC (high dose) once daily

干预措施: BI 10773 low dose placebo (Drug)

BI 10773/linagliptin FDC (high dose)

Experimental

Patients receive BI 10773/linagliptin FDC (high dose) once daily

干预措施: linagliptin placebo (Drug)

BI 10773/linagliptin FDC (low dose)

Experimental

Patients receive BI 10773/linagliptin FDC (low dose) once daily

干预措施: high dose FDC placebo (Drug)

BI 10773/linagliptin FDC (low dose)

Experimental

Patients receive BI 10773/linagliptin FDC (low dose) once daily

干预措施: low dose FDC (Drug)

BI 10773/linagliptin FDC (low dose)

Experimental

Patients receive BI 10773/linagliptin FDC (low dose) once daily

干预措施: high dose BI 10773 placebo (Drug)

BI 10773/linagliptin FDC (low dose)

Experimental

Patients receive BI 10773/linagliptin FDC (low dose) once daily

干预措施: BI 10773 low dose placebo (Drug)

BI 10773/linagliptin FDC (low dose)

Experimental

Patients receive BI 10773/linagliptin FDC (low dose) once daily

干预措施: linagliptin placebo (Drug)

BI 10773 (high dose)

Active Comparator

Patients receive BI 10773 (high dose) once daily

干预措施: BI 10773 high dose (Drug)

BI 10773 (high dose)

Active Comparator

Patients receive BI 10773 (high dose) once daily

干预措施: high dose FDC placebo (Drug)

BI 10773 (low dose)

Active Comparator

Patients receive BI 10773 (low dose) once daily

干预措施: low dose FDC placebo (Drug)

BI 10773 (high dose)

Active Comparator

Patients receive BI 10773 (high dose) once daily

干预措施: low dose FDC placebo (Drug)

BI 10773 (high dose)

Active Comparator

Patients receive BI 10773 (high dose) once daily

干预措施: low dose BI 10773 placebo (Drug)

BI 10773 (high dose)

Active Comparator

Patients receive BI 10773 (high dose) once daily

干预措施: linagliptin placebo (Drug)

BI 10773 (low dose)

Active Comparator

Patients receive BI 10773 (low dose) once daily

干预措施: high dose FDC placebo (Drug)

BI 10773 (low dose)

Active Comparator

Patients receive BI 10773 (low dose) once daily

干预措施: high dose BI 10773 placebo (Drug)

BI 10773 (low dose)

Active Comparator

Patients receive BI 10773 (low dose) once daily

干预措施: BI 10773 low dose (Drug)

BI 10773 (low dose)

Active Comparator

Patients receive BI 10773 (low dose) once daily

干预措施: linagliptin placebo (Drug)

Linagliptin

Active Comparator

Patients receive linagliptin once daily

干预措施: low dose FDC placebo (Drug)

Linagliptin

Active Comparator

Patients receive linagliptin once daily

干预措施: high dose FDC placebo (Drug)

Linagliptin

Active Comparator

Patients receive linagliptin once daily

干预措施: linagliptin (Drug)

Linagliptin

Active Comparator

Patients receive linagliptin once daily

干预措施: high dose BI 10773 placebo (Drug)

Linagliptin

Active Comparator

Patients receive linagliptin once daily

干预措施: low dose BI 10773 placebo (Drug)

结局指标

主要结局

Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients

时间窗: Baseline and 24 weeks

Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients

时间窗: Baseline and 24 weeks

Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.

次要结局

  • Change From Baseline in Body Weight for Metformin Background Patients(Baseline and 24 Weeks)
  • Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients(Baseline and 24 Weeks)
  • Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients(Baseline and 24 Weeks)
  • Change From Baseline in Body Weight for Treatment Naive Patients(Baseline and 24 Weeks)
  • Occurrence of Treat to Target Efficacy Response for Metformin Background Patients(24 Weeks)
  • Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients(24 Weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (211)

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