- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01817777
An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
18. november 2016 oppdatert av: GlaxoSmithKline
A Pharmacy Based Open Study to Evaluate Whether Pack Size Affects Compliance for Subjects Diagnosed With Diabetes Type II Who Are Established on Metformin Treatment
MTF116086 is an open-label, randomised, parallel-design study in subjects with type II diabetes.
The study is site-based, with local pharmacies serving as the sites and pharmacists as principal investigators for the sites.
All subjects will enter an initial 8-week observational phase during which purchase behaviour and compliance with usual metformin use will be observed and recorded.
At the end of the observational phase, subjects will be randomised to one of the two arms (metformin small pack vs. metformin large pack) for a 20-week interventional phase.
The medication in the interventional phase is provided to the subjects free of charge.
HbA1c will be collected for all subjects during Week 0, Week 8, and Week 28.
Subjects will be asked questions about their tablet compliance, their satisfaction with the pack size they received and reasons for missing doses throughout the interventional phase by the pharmacist.
The pharmacy visit on Week 28 will be end of the study.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
31
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Correintes, Argentina
- GSK Investigational Site
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Corrientes, Argentina
- GSK Investigational Site
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Mendoza, Argentina, 5515
- GSK Investigational Site
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Mendoza, Argentina, 5539
- GSK Investigational Site
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Mendoza, Argentina
- GSK Investigational Site
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Provincia de Buenos Aires, Argentina, 1754
- GSK Investigational Site
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Tucumán, Argentina, T 4000IOE
- GSK Investigational Site
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Males and females of age >=18 years
- Diagnosis of type II diabetes
- HbA1c value no higher than 9.0%
- Evidence of physician-supplied prescription for metformin use
- Stable dose of metformin for 3 months prior to enrolment
- Written informed consent from the subject
Exclusion Criteria:
- Current use of any anti-diabetic medication other than metformin
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: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Metformin Small Pack Arm
All subjects in the study will be initially followed for an 8-week observational phase during which subjects will visit the pharmacy and purchase metformin following their usual routines.
After 8-weeks subjects will be randomised to one of the 2 treatments arms.
Subjects in the metformin small pack arm will receive medication free of charge in a small pack.
Dosing of metformin will not be dictated by the protocol.
Subjects will remain on their prescribed dose of metformin throughout the study, unless a change is recommended by their physician.
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A single small pack of metformin will consist of a blister package containing 10 pills with a patient information leaflet in local language.
The small packs will be available at each site in the following doses: 500 mg, 850 mg, and 1000 mg.
The small pack size of metformin is not yet marketed.
Small pack metformin will be provided by GSK as GSK brand metformin.
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Eksperimentell: Metformin Large Pack Arm
All subjects in the study will be initially followed for an 8-week observational phase during which subjects will visit the pharmacy and purchase metformin following their usual routines.
After 8-weeks subjects will be randomised to one of the 2 treatments arms.
Subjects in the metformin large pack arm will receive medication free of charge in a large, monthly pack.
Dosing of metformin will not be dictated by the protocol.
Subjects will remain on their prescribed dose of metformin throughout the study, unless a change is recommended by their physician.
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The large pack will consist of 1 month's supply of metformin.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline in HbA1c Values at Week 28
Tidsramme: Baseline (Week 8) and Week 28
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HbA1c was tested with a point-of-care device, which required a finger prick to obtain blood and provided an immediate result upon analysis in the device.
HbA1c was tested at pharmacy visits corresponding to three time points: enrollment (Week 0), Baseline (Week 8), and End of Study (Week 28).
The difference in the mean change from Baseline was to be calculated between the treatment arms (small pack minus large pack), and the 2-sided 95% confidence interval for the difference in mean change in HbA1c was to be calculated.
However, because the study was terminated early, and the sample size was reduced, the statistical hypotheses defined in the protocol were not tested due to insufficient power.
Therefore, the final analyses were limited to descriptive statistics.
The percentage HbA1c is a measure of how much of the hemoglobin in the blood has become glycated (chemically bounded to glucose).
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Baseline (Week 8) and Week 28
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Mean Percent Compliance Throughout the Interventional Phase
Tidsramme: From Randomization to Week 28
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Compliance for the study was estimated as a percentage, with the denominator defined as the number of pills dispensed by the pharmacist and the numerator defined as the number of pills taken, accounting for remaining pills at subsequent pharmacy visits.
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From Randomization to Week 28
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Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase
Tidsramme: From enrollment to Week 8
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Compliance was estimated during the 8-week Observational Phase for usual metformin treatment.
During the Observational Phase, compliance was measured by monitoring the number of pill dispensed and the return of the pills or tablets.
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From enrollment to Week 8
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Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days
Tidsramme: Week 28
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The number of days on which no metformin pills were taken by participants was summarized.
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Week 28
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Number of Participants With Diabetes Disease Management Modifications
Tidsramme: Week 28
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Throughout the duration of the study, participants remained on their recommended metformin dosing regimens, unless a change in metformin dose was prescribed by their physician.
The number of participants who received additional diabetes therapy for the management of diabetes was summarized.
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Week 28
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Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes
Tidsramme: Week 28
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The number of participants who visited a health care professional for diabetes management during the study was summarized.
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Week 28
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Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication
Tidsramme: Week 28
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Number of participants who preferred their treatment regimens (interventional arm treatment [large or small pack metformin]) to how they previously took their medication are presented.
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Week 28
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Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons
Tidsramme: Week 28
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The number of particiapnts who missed days or doses of metformin was summarized.
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Week 28
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Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up
Tidsramme: Week 28
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The number of participants who voluntarily discontinued participation in the study at any time or who were withdrawn by the investigator for pre-defined reasons was summarized.
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Week 28
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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. mai 2013
Primær fullføring (Faktiske)
1. februar 2014
Studiet fullført (Faktiske)
1. februar 2014
Datoer for studieregistrering
Først innsendt
21. mars 2013
Først innsendt som oppfylte QC-kriteriene
21. mars 2013
Først lagt ut (Anslag)
25. mars 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
9. januar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. november 2016
Sist bekreftet
1. november 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 116086
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
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Annotert saksrapportskjema
Informasjonsidentifikator: 116086Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informasjonsidentifikator: 116086Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasett for individuell deltaker
Informasjonsidentifikator: 116086Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Skjema for informert samtykke
Informasjonsidentifikator: 116086Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informasjonsidentifikator: 116086Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasettspesifikasjon
Informasjonsidentifikator: 116086Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informasjonsidentifikator: 116086Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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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