4 Weeks Treatment of Type II Diabetic Patients With BI 44847
2014年4月30日 更新者:Boehringer Ingelheim
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.
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.
調査の概要
研究の種類
介入
入学 (実際)
80
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年~70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Weight and waist circumference - change from baseline
時間枠:Day 28 (Hour = 647:30)
|
Day 28 (Hour = 647:30)
|
Frequency of patients with maximal increase from baseline QTcF and QTcB interval
時間枠:4 weeks
|
4 weeks
|
Frequency of patients with possible clinically significant abnormalities
時間枠:4 weeks
|
4 weeks
|
Micturition total frequency - change from baseline
時間枠:Day 28
|
Day 28
|
Global tolerability - number of patients by category
時間枠:4 weeks
|
4 weeks
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Cmax (maximum concentration of the analyte in plasma)
時間枠:Day 1
|
Day 1
|
Tmax (time from dosing to maximum concentration)
時間枠:Day 1
|
Day 1
|
t1/2 (terminal half-life of the analyte in plasma)
時間枠:Day 1
|
Day 1
|
λz (terminal rate constant in plasma)
時間枠:Day 1
|
Day 1
|
C12,1 (concentration of analyte in plasma at 12 hours post-drug administration after administration of the first dose)
時間枠:Day 1
|
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)
時間枠:Day 1
|
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)
時間枠:Day 1
|
Day 1
|
Ae0-12 (amount of analyte that is eliminated in urine over the time interval 0 h to 12 h)
時間枠:Day 1
|
Day 1
|
fe0-12 (fraction of analyte excreted unchanged in urine from time points 0 h to 12 h)
時間枠:Day 1
|
Day 1
|
CLR (renal clearance of the analyte in plasma after extravascular administration - based on 0 - 12 hour data)
時間枠:Day 1
|
Day 1
|
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
時間枠:Day 1
|
Day 1
|
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
時間枠:Day 1
|
Day 1
|
Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval)
時間枠:Day 28
|
Day 28
|
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)
時間枠:Day 28
|
Day 28
|
Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N)
時間枠:Day 28
|
Day 28
|
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the last dose)
時間枠:Day 28
|
Day 28
|
C12,ss (concentration of analyte in plasma at 12 hours post-drug administration at steady state)
時間枠:Day 28
|
Day 28
|
tmax,ss (time from dosing to maximum concentration at steady state)
時間枠:Day 28
|
Day 28
|
tmin,ss (time from dosing to minimum concentration during a dosing interval)
時間枠:Day 28
|
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)
時間枠:Day 28
|
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)
時間枠:Day 28
|
Day 28
|
MRTpo,ss (mean residence time of the analyte in the body after 56 administrations (b.i.d.) at steady state)
時間枠:Day 28
|
Day 28
|
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
時間枠:Day 28
|
Day 28
|
Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)
時間枠:Day 28
|
Day 28
|
Ae0-12,ss (amount of analyte that is eliminated in urine at steady state over the time interval 0 to 12 h)
時間枠:Day 28
|
Day 28
|
fe0-12,ss (fraction of analyte excreted unchanged in urine at steady state over the time interval 0 to 12 h)
時間枠:Day 28
|
Day 28
|
CLR,ss (renal clearance of the analyte at steady state - based on 0 - 12 hour data)
時間枠:Day 28
|
Day 28
|
RA,Cmax based on Cmax
時間枠:following 55 doses (bid)
|
following 55 doses (bid)
|
RA,AUC based on AUCτ
時間枠:following 55 doses (bid)
|
following 55 doses (bid)
|
Predose concentrations of the analyte in plasma
時間枠:5 minutes before drug administration on days 2,3,4,7,14,21,26,27,28 and 29
|
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
時間枠:Day 27
|
Day 27
|
Change from baseline in weighted MDG, AUEC0-24
時間枠:Day 27
|
Day 27
|
Epre-corrected AUEC0-5 following OGTT
時間枠:Day 28
|
Day 28
|
Cavg (average concentration)
時間枠:day 28
|
day 28
|
PTF (peak trough fluctuation).
時間枠:day 28
|
day 28
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年6月1日
一次修了 (実際)
2007年11月1日
試験登録日
最初に提出
2007年8月30日
QC基準を満たした最初の提出物
2007年11月14日
最初の投稿 (見積もり)
2007年11月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年5月1日
QC基準を満たした最後の更新が送信されました
2014年4月30日
最終確認日
2014年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
2型糖尿病の臨床試験
BI 44847の臨床試験
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