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临床试验/NCT00881530
NCT00881530已完成2 期

A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients

Boehringer Ingelheim137 个研究点 分布在 8 个国家目标入组 660 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
660
试验地点
137
主要终点
Change From Baseline to Week 78 in Lipid Parameters

研究概览

简要总结

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

BI 10773 X mg

Experimental

lower dose

干预措施: BI 10773 (Drug)

Sitagliptin

Active Comparator

100 mg

干预措施: Sitagliptin (Drug)

Metformin

Active Comparator

2000 mg

干预措施: Metformin (Drug)

BI 10773 Y mg

Experimental

higher dose

干预措施: BI 10773 (Drug)

结局指标

主要结局

Change From Baseline to Week 78 in Lipid Parameters

时间窗: Weeks 1 and 78

Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)

Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements

时间窗: 78 weeks plus 1 week of follow-up

Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.

Hypoglycaemic Events

时间窗: 78 weeks plus 1 week of follow-up

Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration: * Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of \<54 mg/dL (\<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance * Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions

次要结局

  • Occurence of a Treat-to-target Response (HbA1c < 7.0%)(Weeks 1, 6, 18, 30, 42, 54, 66 and 78)
  • Change From Baseline in HbA1c Over Time(Weeks 1, 6, 18, 30, 42, 54, 66 and 78)
  • Occurrence of a Treat-to-target Response (HbA1c < 6.5%)(Weeks 1, 6, 18, 30, 42, 54, 66 and 78)
  • Occurrence of a Relative Efficacy Response(Weeks 1, 6, 18, 30, 42, 54, 66 and 78)
  • Change From Baseline in Fasting Plasma Glucose (FPG) Over Time(Weeks 1, 6, 18, 30, 42, 54, 66 and 78)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (137)

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