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
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
- 否
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
lower dose
干预措施: BI 10773 (Drug)
Sitagliptin
100 mg
干预措施: Sitagliptin (Drug)
Metformin
2000 mg
干预措施: Metformin (Drug)
BI 10773 Y mg
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)
