- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01065766
Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)
18. februar 2015 oppdatert av: Merck Sharp & Dohme LLC
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of JANUMET in Usual Practice
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
4065
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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin in usual practice
Beskrivelse
Inclusion Criteria:
- Has type 2 diabetes mellitus
- Is treated with sitagliptin/metformin within local label for the first time
Exclusion Criteria:
- Has a contraindication to sitagliptin/metformin according to the local label
- Is treated with sitagliptin/metformin before contract and out of enrollment period
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
All participants
Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
|
Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Any Adverse Experience
Tidsramme: Up to 26 weeks
|
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
|
Up to 26 weeks
|
Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12
Tidsramme: Baseline and Week 12
|
HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin.
The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%).
The change from baseline reflects the Week 12 A1C minus Week 0 A1C.
|
Baseline and Week 12
|
Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12
Tidsramme: Baseline and Week 12
|
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast).
FPG is expressed as mg/dL.
Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.
|
Baseline and Week 12
|
Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12
Tidsramme: Baseline and Week 12
|
Blood glucose was measured 2 hours after a meal (2hr-PPG).
2hr-PPG is expressed as mg/dL.
Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.
|
Baseline and Week 12
|
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12
Tidsramme: At Week 12
|
Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator.
The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
|
At Week 12
|
Change From Baseline to Treatment in HbA1c at Week 24
Tidsramme: Baseline and Week 24
|
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).
Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.
|
Baseline and Week 24
|
Change From Baseline to Treatment in FPG at Week 24
Tidsramme: Baseline and Week 24
|
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast).
FPG is expressed as mg/dL.
Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.
|
Baseline and Week 24
|
Change From Baseline in 2hr-PPG at Week 24
Tidsramme: Baseline and Week 24
|
Blood glucose was measured 2 hours after a meal (2hr-PPG).
2hr-PPG is expressed as mg/dL.
Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.
|
Baseline and Week 24
|
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24
Tidsramme: At Week 24
|
Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator.
The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
|
At Week 24
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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. mars 2009
Primær fullføring (Faktiske)
1. mai 2013
Studiet fullført (Faktiske)
1. mai 2013
Datoer for studieregistrering
Først innsendt
8. februar 2010
Først innsendt som oppfylte QC-kriteriene
8. februar 2010
Først lagt ut (Anslag)
9. februar 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. mars 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. februar 2015
Sist bekreftet
1. februar 2015
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
- Metformin
- Sitagliptinfosfat
Andre studie-ID-numre
- 0431A-182
- 2010_006 (Annen identifikator: Merck)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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