- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00935220
Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
17. juni 2014 opdateret af: Boehringer Ingelheim
An Open Label, Phase I Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Linagliptin (BI 1356) 5 mg After Single and Multiple Oral Administration in Patients With Type 2 Diabetes Mellitus of African American Origin for 7 Days
The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of African American origin.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
41
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Cypress, California, Forenede Stater
- 1218.55.0006 Boehringer Ingelheim Investigational Site
-
-
Florida
-
Deland, Florida, Forenede Stater
- 1218.55.0008 Boehringer Ingelheim Investigational Site
-
Miami, Florida, Forenede Stater
- 1218.55.0004 Boehringer Ingelheim Investigational Site
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater
- 1218.55.0005 Boehringer Ingelheim Investigational Site
-
-
New York
-
New York, New York, Forenede Stater
- 1218.55.0003 Boehringer Ingelheim Investigational Site
-
-
Texas
-
Dallas, Texas, Forenede Stater
- 1218.55.0001 Boehringer Ingelheim Investigational Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion criteria:
- Glycosylated haemoglobin >=7 and <= 10%
- Age >=21 and <= 65
- Body Mass Index >=18.5 and <=38 kg/m2
- African American origin
- Signed and dated informed consent prior to admission to the study
Exclusion criteria:
- Any finding of the medical examination considered clinically relevant by the Investigator
- Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular disease including hypertension >160-100 mmHg (under current treatment), stroke and transient ischemic attack (TIA).
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes
- Clinically relevant diseases of central nervous system or psychiatric disorders or relevant neurological disorders besides polyneuropathy
- Diagnosis of sickle cell anemia or known chronic anemia
- History of chronic or relevant infections (for example human immunodeficieny virus (HIV), Hepatitis B)
- History of relevant allergy/hypersensitivity
- Intake of drugs with a long half life (>24hours) within at least one month or less than 10 half lives of the respective drug prior to administration except allowed co medication
- Alcohol abuse, drug abuse
- Any laboratory value of clinical relevance that is outside an acceptable range
- Change of drug dosing of allowed co medication
- Any (electrocardiogram) ECG value outside the reference range and of clinical relevance.
- Fasted glucose >270 mg/dl or randomly determined blood glucose >400 mg/dl on two consecutive days during screening or wash out
- Serum creatinine above upper limit normal at screening
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: linagliptin
Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation
|
dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Linagliptin: AUC_τ,ss
Tidsramme: 24 hours
|
area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval
|
24 hours
|
Linagliptin: C_max,ss
Tidsramme: 24 hours
|
maximum concentration of linagliptin in plasma at steady state
|
24 hours
|
DPP-4 Inhibition: E_24,ss
Tidsramme: One single measurement 24 h after drug administration under steady state conditions
|
Plasma DPP-4 inhibition at trough under steady state conditions.
Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.
|
One single measurement 24 h after drug administration under steady state conditions
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Treatment Emergent Adverse Events
Tidsramme: 21 days
|
Frequency of patients with AEs
|
21 days
|
Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
Tidsramme: 21 days
|
12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities
|
21 days
|
Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event
Tidsramme: 21 days
|
Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event
|
21 days
|
Linagliptin: AUC_0-24
Tidsramme: 24 hours
|
area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose
|
24 hours
|
Linagliptin: C_max
Tidsramme: 24h
|
maximum concentration of linagliptin in plasma on Day 1
|
24h
|
DPP-4 Inhibition: E_24
Tidsramme: One single measurement 24 h after drug administration
|
Plasma DPP-4 inhibition 24 hours after first dose.
Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.
|
One single measurement 24 h after drug administration
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2009
Primær færdiggørelse (Faktiske)
1. august 2010
Datoer for studieregistrering
Først indsendt
1. juli 2009
Først indsendt, der opfyldte QC-kriterier
7. juli 2009
Først opslået (Skøn)
8. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. juni 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juni 2014
Sidst verificeret
1. februar 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes mellitus, type 2
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehæmmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hæmmere
- Linagliptin
Andre undersøgelses-id-numre
- 1218.55
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Diabetes mellitus, type 2
-
University Hospital Inselspital, BerneAfsluttetType 2 diabetes mellitusSchweiz
-
India Diabetes Research Foundation & Dr. A. Ramachandran...Afsluttet
-
AstraZenecaRekruttering
-
Daewoong Pharmaceutical Co. LTD.Ikke rekrutterer endnuT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRekrutteringType 2 diabetes mellitus (T2DM)Kina
-
Newsoara Biopharma Co., Ltd.RekrutteringT2DM (Type 2 Diabetes Mellitus)Kina
-
Shanghai Golden Leaf MedTec Co. LtdAktiv, ikke rekrutterendeType 2 diabetes mellitus (T2DM)Kina
-
SanofiAfsluttet
-
Haisco Pharmaceutical Group Co., Ltd.AfsluttetT2DM (Type 2 Diabetes Mellitus)Kina
-
PegBio Co., Ltd.AfsluttetType 2 diabetes mellitus (T2DM)Kina