NCT00558571已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Weeks Treatment With Three Oral Doses of BI 10773 as Tablets in Female and Male Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- Number of Subjects With Drug Related Adverse Events
研究概览
简要总结
Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and postmenopausal or hysterectomised female patients with type 2 diabetes
- •Age >18 and < 70 years
- •BMI >18.5 and <40 kg/m2
排除标准
- •Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent;
- •Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) or a blood glucose level above 400 mg/dl (22.2 mmol/L) postprandially;
- •HbA1c > 8.5 %
研究组 & 干预措施
BI 10773 high dose
Experimental
干预措施: BI 10773 high dose (Drug)
BI 10773 medium dose
Experimental
干预措施: BI 10773 medium dose (Drug)
Placebo
Placebo Comparator
干预措施: placebo to BI 10773 (Drug)
BI 10773 low dose
Experimental
干预措施: BI 10773 low dose (Drug)
结局指标
主要结局
Number of Subjects With Drug Related Adverse Events
时间窗: from drug administration up to 6 weeks
number of subjects with investigator-defined drug-related adverse events.
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG
时间窗: from drug administration up to 6 weeks
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
次要结局
- AUC0-∞ of Empagliflozin(0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1)
- Fasting Plasma Glucose (FPG)(in the morning of days -1 and 28)
- Cmax of Empagliflozin(0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28)
- CL/F of Empaglifozin(0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28)
- Tmax of Empagliflozin(0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28)
- Ae0-24 of Glucose(Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h)
- Insulin Emax (Maximum Measured Effect)(0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.)
- Glucagon Emax (Maximum Measured Effect)(0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.)
- t1/2 of Empagliflozin(0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28)
- LI (Linearity Index).(0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28)
- fe0-24 of Empagliflozin(0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28)
- Mean Daily Glucose (MDG) Measured in Blood(0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27)
- Insulin AUEC0-5(0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.)
- Fasting Insulin(in the morning of days -1( baseline), 1, 7, 14, 21 and 28)
- Glucagon AUEC0-5(0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.)
- Fructosamine(day -1 (baseline), 14 and 28)
- HbA1c(in the morning of days -1 and 28)
研究者
研究点 (3)
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