- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00871507
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Explores What the Body Does to the Drug), and Pharmacodynamics (Explores What a Drug Does to the Body) of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus
21. mai 2014 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
SD in Subjects With T2DM
This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of JNJ-38431055 in volunteers with type 2 diabetes mellitus.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a double-blind (neither physician or participant knows name of the assigned study drug), placebo-controlled (substance containing no medication), crossover study in male and female volunteers with type 2 diabetes mellitus.
For each volunteer, the study consists of a screening phase (up to 45 days), a run-in phase during which volunteers discontinue their oral hypoglycemic drugs (28 days), a treatment phase during which volunteers will continue to be off their oral hypoglycemic drugs (28 days) and will receive 4 single dose study treatments in a randomized (study sequence assigned by chance) sequence, and a follow-up phase (10 days).
After the follow-up phase volunteers will restart their oral hypoglycemic drugs.
During the treatment phase there will be at least 7 days between each of the 4 treatments.
The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055, sitagliptin (Januvia), and placebo.
The following safety evaluations will be taken throughout the study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the electrical activity of the heart), Blood pressure, heart rate, and blood samples for laboratory tests.
The primary outcome will be incremental glucose after an oral glucose tolerance test.
Study drug will be administered as single oral doses separated by at least 7 days.
The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055, sitagliptin (Januvia), and placebo.
Studietype
Intervensjonell
Registrering (Faktiske)
25
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Florida
-
Fort Myers, Florida, Forente stater
-
-
Texas
-
San Antonio, Texas, Forente stater
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
25 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Males or postmenopausal or surgically sterilized females, who have type 2 diabetes mellitus
- Medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and ECG performed at Screening
- Body Mass Index (BMI) between 22 and 39.9 kg/m2, inclusive
- On a generally stable antihyperglycemic agent regimen (i.e., with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to the Screening Visit, including volunteers who are:(a) Not currently on antihyperglycemic therapy and have an HbA1c =7.0% and =10.0%, or (b) On a single oral antihyperglycemic agent [metformin, a sulfonylurea, a meglitinide (e.g., repaglininide or nateglinide), a DPP-4 inhibitor (sitagliptin or vildagliptin), or an alpha-glucosidase inhibitor (e.g., acarbose)] and have an HbA1c >=6.5% and <=9.5%, or (c) On low-dose dual oral agent therapy (i.e., <50% maximum labeled doses of both agents) and have an HbA1c >=6.5% and <=9.5%
- On Day -1, FPG concentrations between 120 mg/dL and 260 mg/dL, inclusive.
Exclusion Criteria:
- Taking non-oral antihyperglycemic agent (e.g., insulin, exenatide or other GLP-1 analogues), or taking a thiazolidinedione (i.e., a PPARg agonist) within 3 months of Day -1
- History of a recent severe hypoglycemic episode, recurrent hypoglycemic episodes (i.e., within the past year), or a history of hypoglycemic unawareness
- History of clinically significant diabetic complications, including retinopathy, nephropathy, neuropathy or gastroparesis
- Positive test for alcohol and/or drugs of abuse
- Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
- Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 001
|
Liquid suspension/solution of JNJ-38431055 administered as a single dose
|
|
Eksperimentell: 002
|
Liquid suspension/solution of JNJ-38431055 administered as a single dose
|
|
Placebo komparator: 003
|
Placebo suspension/solution and Placebo capsule administered as single doses
|
|
Aktiv komparator: 004
|
Capsule containing 100 mg of sitagliptin administered as a single dose.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incremental glucose AUC after an oral glucose tolerance test (OGTT)
Tidsramme: 0-4 hours after OGTT
|
0-4 hours after OGTT
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Safety and Tolerability
Tidsramme: Throughout study
|
Throughout study
|
|
Incremental glucose AUC after a meal tolerance test (MTT)
Tidsramme: 0-4 hours after MTT
|
0-4 hours after MTT
|
|
Measurements of beta-cell function
Tidsramme: 0-4 hours after OGTT/MTT
|
0-4 hours after OGTT/MTT
|
|
Effect on incretin levels
Tidsramme: 0-4 hours after OGTT
|
0-4 hours after OGTT
|
|
Pharmacokinetics
Tidsramme: 48 hours after dosing
|
48 hours after dosing
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2009
Primær fullføring (Faktiske)
1. juli 2009
Studiet fullført (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først innsendt
26. mars 2009
Først innsendt som oppfylte QC-kriteriene
26. mars 2009
Først lagt ut (Anslag)
30. mars 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
22. mai 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. mai 2014
Sist bekreftet
1. mai 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i det endokrine systemet
- Sukkersyke
- Diabetes mellitus, type 2
- Hypoglykemiske midler
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehemmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hemmere
- Sitagliptinfosfat
Andre studie-ID-numre
- CR016048
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