NCT00558909已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Weeks Treatment With Three Selected Oral Doses of BI 44847 as Tablet in Female and Male Patients With Type 2 Diabetes.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Weight and waist circumference - change from baseline
研究概览
简要总结
The primary objective of the current study is to investigate the safety and tolerability of BI 44847 in male and female patients with type 2 diabetes following oral administration of repeated doses of 100 mg b.i.d, 400 mg b.i.d. and 800 mg b.i.d. over 28 days.
A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 44847 after multiple dosing, including assessment of steady state.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 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 proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or with one or 2 oral hypoglycaemic agent other than glitazones. In case of 2 oral hypoglycaemic agents, at least one of these may be taken at no more than 50% of its maximum dose;
- •Age = > 21 and Age = <70 years (female hysterectomised and male patients);
- •Age = >55 and Age = <70 years (female postmenopausal patients);
- •BMI = >18.5 and BMI = <40 kg/m2 (Body Mass Index);
- •Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
排除标准
- •Treatment with insulin, glitazones, or more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of maximum dose);
- •Fasted blood glucose > 240 mg/dl on two consecutive days during wash-out; HbA1c > 8.5 % at screening;
- •Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension;
- •History of relevant allergy/hypersensitivity;
- •Marked baseline prolongation of QT/QTc interval;
- •History of additional risk factors for TdP;
- •Any laboratory value outside the reference range and the clinical relevance is not acceptable in the opinion of the investigator, or the value is more than 3 times higher than the upper limit of the reference range;
- •Concomitant medication except for acetylsalicylic acid, statins, antihypertensives (diuretics not allowed), beta-blockers for BPH and occasional use of paracetamol (doses of no more than 1000 mg; no more than 2000 mg per day; no more than 2 days per week);
- •Change of drug dosing of allowed co-medication < the last 6 weeks; Intake of any medication < 5 half-lives of the respective drug prior to first administration of study medication or during the trial, except allowed co-medication;
- •Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval (based on the knowledge at the time of patient inclusion) < 10 days prior to first administration of study medication or during the trial;
- •Use of grapefruit (or its juice) < 10 days prior to first administration of study medication or during the trial;
- •Participation in another trial with an investigational drug < two months prior to first administration of study medication or during the trial; Smoker;
- •Inability to refrain from smoking on specified trial days; Alcohol abuse;
- •Drug abuse;
- •Blood donation;
- •Excessive physical activity;
- •Male patients not using adequate contraception;
- •Women of childbearing potential, positive pregnancy test or lactating
结局指标
主要结局
Weight and waist circumference - change from baseline
时间窗: Day 28 (Hour = 647:30)
Frequency of patients with maximal increase from baseline QTcF and QTcB interval
时间窗: 4 weeks
Frequency of patients with possible clinically significant abnormalities
时间窗: 4 weeks
Micturition total frequency - change from baseline
时间窗: Day 28
Global tolerability - number of patients by category
时间窗: 4 weeks
次要结局
- PTF (peak trough fluctuation).(day 28)
- Cmax (maximum concentration of the analyte in plasma)(Day 1)
- Tmax (time from dosing to maximum concentration)(Day 1)
- t1/2 (terminal half-life of the analyte in plasma)(Day 1)
- λz (terminal rate constant in plasma)(Day 1)
- C12,1 (concentration of analyte in plasma at 12 hours post-drug administration after administration of the first dose)(Day 1)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the first dosing interval)(Day 1)
- AUC0-12 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 h after administration of the first dose)(Day 1)
- Ae0-12 (amount of analyte that is eliminated in urine over the time interval 0 h to 12 h)(Day 1)
- fe0-12 (fraction of analyte excreted unchanged in urine from time points 0 h to 12 h)(Day 1)
- CLR (renal clearance of the analyte in plasma after extravascular administration - based on 0 - 12 hour data)(Day 1)
- CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(Day 1)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(Day 1)
- Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval)(Day 28)
- Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)(Day 28)
- Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N)(Day 28)
- Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the last dose)(Day 28)
- C12,ss (concentration of analyte in plasma at 12 hours post-drug administration at steady state)(Day 28)
- tmax,ss (time from dosing to maximum concentration at steady state)(Day 28)
- tmin,ss (time from dosing to minimum concentration during a dosing interval)(Day 28)
- AUC0-tz,ss (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the last dosing interval)(Day 28)
- AUC0-12,ss (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 h at steady-state)(Day 28)
- MRTpo,ss (mean residence time of the analyte in the body after 56 administrations (b.i.d.) at steady state)(Day 28)
- CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)(Day 28)
- Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)(Day 28)
- Ae0-12,ss (amount of analyte that is eliminated in urine at steady state over the time interval 0 to 12 h)(Day 28)
- fe0-12,ss (fraction of analyte excreted unchanged in urine at steady state over the time interval 0 to 12 h)(Day 28)
- CLR,ss (renal clearance of the analyte at steady state - based on 0 - 12 hour data)(Day 28)
- RA,Cmax based on Cmax(following 55 doses (bid))
- RA,AUC based on AUCτ(following 55 doses (bid))
- Predose concentrations of the analyte in plasma(5 minutes before drug administration on days 2,3,4,7,14,21,26,27,28 and 29)
- Change from baseline in UGE, AE0-24(Day 27)
- Change from baseline in weighted MDG, AUEC0-24(Day 27)
- Epre-corrected AUEC0-5 following OGTT(Day 28)
- Cavg (average concentration)(day 28)
研究者
研究点 (4)
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