- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00558909
4 Weeks Treatment of Type II Diabetic Patients With BI 44847
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskelupaikat
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Zuidlaren, Alankomaat
- 1224.4.31001 Boehringer Ingelheim Investigational Site
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-
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Berlin, Saksa
- 1224.4.49002 Boehringer Ingelheim Investigational Site
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Mainz, Saksa
- 1224.4.49003 Boehringer Ingelheim Investigational Site
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Neuss, Saksa
- 1224.4.49001 Boehringer Ingelheim Investigational Site
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
Weight and waist circumference - change from baseline
Aikaikkuna: Day 28 (Hour = 647:30)
|
Day 28 (Hour = 647:30)
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Frequency of patients with maximal increase from baseline QTcF and QTcB interval
Aikaikkuna: 4 weeks
|
4 weeks
|
Frequency of patients with possible clinically significant abnormalities
Aikaikkuna: 4 weeks
|
4 weeks
|
Micturition total frequency - change from baseline
Aikaikkuna: Day 28
|
Day 28
|
Global tolerability - number of patients by category
Aikaikkuna: 4 weeks
|
4 weeks
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
Cmax (maximum concentration of the analyte in plasma)
Aikaikkuna: Day 1
|
Day 1
|
Tmax (time from dosing to maximum concentration)
Aikaikkuna: Day 1
|
Day 1
|
t1/2 (terminal half-life of the analyte in plasma)
Aikaikkuna: Day 1
|
Day 1
|
λz (terminal rate constant in plasma)
Aikaikkuna: Day 1
|
Day 1
|
C12,1 (concentration of analyte in plasma at 12 hours post-drug administration after administration of the first dose)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: Day 1
|
Day 1
|
Ae0-12 (amount of analyte that is eliminated in urine over the time interval 0 h to 12 h)
Aikaikkuna: Day 1
|
Day 1
|
fe0-12 (fraction of analyte excreted unchanged in urine from time points 0 h to 12 h)
Aikaikkuna: Day 1
|
Day 1
|
CLR (renal clearance of the analyte in plasma after extravascular administration - based on 0 - 12 hour data)
Aikaikkuna: Day 1
|
Day 1
|
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Aikaikkuna: Day 1
|
Day 1
|
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Aikaikkuna: Day 1
|
Day 1
|
Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval)
Aikaikkuna: Day 28
|
Day 28
|
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)
Aikaikkuna: Day 28
|
Day 28
|
Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N)
Aikaikkuna: Day 28
|
Day 28
|
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the last dose)
Aikaikkuna: Day 28
|
Day 28
|
C12,ss (concentration of analyte in plasma at 12 hours post-drug administration at steady state)
Aikaikkuna: Day 28
|
Day 28
|
tmax,ss (time from dosing to maximum concentration at steady state)
Aikaikkuna: Day 28
|
Day 28
|
tmin,ss (time from dosing to minimum concentration during a dosing interval)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: Day 28
|
Day 28
|
MRTpo,ss (mean residence time of the analyte in the body after 56 administrations (b.i.d.) at steady state)
Aikaikkuna: Day 28
|
Day 28
|
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Aikaikkuna: Day 28
|
Day 28
|
Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: Day 28
|
Day 28
|
CLR,ss (renal clearance of the analyte at steady state - based on 0 - 12 hour data)
Aikaikkuna: Day 28
|
Day 28
|
RA,Cmax based on Cmax
Aikaikkuna: following 55 doses (bid)
|
following 55 doses (bid)
|
RA,AUC based on AUCτ
Aikaikkuna: following 55 doses (bid)
|
following 55 doses (bid)
|
Predose concentrations of the analyte in plasma
Aikaikkuna: 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
Aikaikkuna: Day 27
|
Day 27
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Change from baseline in weighted MDG, AUEC0-24
Aikaikkuna: Day 27
|
Day 27
|
Epre-corrected AUEC0-5 following OGTT
Aikaikkuna: Day 28
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Day 28
|
Cavg (average concentration)
Aikaikkuna: day 28
|
day 28
|
PTF (peak trough fluctuation).
Aikaikkuna: day 28
|
day 28
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 1224.4
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