A Phase II, Randomised, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 (1 mg, 5 mg, 10 mg, and 25 mg) for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Change From Baseline in Urine Glucose Excretion
研究概览
简要总结
The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.
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
- 20 Years 至 70 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
BI 10773 low dose quaque die (QD)
patient to receive a BI 10773 low dose tablet and a placebo tablet once daily
干预措施: Placebo (low dose) (Drug)
BI 10773 mid-high dose QD
patient to receive two tablets of BI 10773 middle dose once daily
干预措施: BI 10773 (Drug)
BI 10773 low dose quaque die (QD)
patient to receive a BI 10773 low dose tablet and a placebo tablet once daily
干预措施: BI 10773 (Drug)
BI 10773 mid-low dose QD
patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily
干预措施: Placebo (middle dose) (Drug)
BI 10773 mid-low dose QD
patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily
干预措施: BI 10773 (Drug)
BI 10773 high dose QD
patient to receive a BI 10773 high dose tablet and a placebo tablet once daily
干预措施: BI 10773 (Drug)
BI 10773 high dose QD
patient to receive a BI 10773 high dose tablet and a placebo tablet once daily
干预措施: Placebo (high dose) (Drug)
Placebo
patient to receive two tablets of placebo once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Urine Glucose Excretion
时间窗: baseline and 28 days
Change from baseline in Urine glucose excretion to 28 days
Change From Baseline in 8-point Glucose
时间窗: baseline and 27 days
Change from baseline in 8-point glucose to 27 days
Change From Baseline in Fasting Plasma Glucose
时间窗: baseline and 28 days
Change from baseline in Fasting plasma glucose to 28 days
次要结局
- Change From Baseline in HbA1c(baseline and 28 days)
- CL/F(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
- Vz/F(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
- Change From Baseline in Fructosamine(baseline and 28 days)
- Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)(baseline and 28 days)
- Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)(baseline and 28 days)
- fe0-24(0-5, 5-12, 12-24 hour after first drug administration)
- Cmax,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration)
- CLR,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration)
- Change From Baseline in 1,5-anhydroglucitol(baseline and 28 days)
- Change From Baseline in Fasting Insulin(baseline and 28 days)
- Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)(baseline and 28 days)
- AUCτ,1(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
- AUC0-tz(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
- AUC0-∞(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
- Cmax(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
- Ae0-24(0-5, 5-12, 12-24 hour after first drug administration)
- CLR,0-24(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration)
- RA,Cmax(Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration)
- t1/2(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
- AUCτ,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration)
- t1/2,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration)
- CL/F,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration)
- Vz/F,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration)
- RA,AUC(Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration)
- Ae0-24,ss(0-5, 5-12, 12-24 hour after last drug administration)
- fe0-24,ss(0-5, 5-12, 12-24 hour after last drug administration)