An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
18. listopadu 2016 aktualizováno: 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.
Přehled studie
Postavení
Ukončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
31
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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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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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Baseline in HbA1c Values at Week 28
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Mean Percent Compliance Throughout the Interventional Phase
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. května 2013
Primární dokončení (Aktuální)
1. února 2014
Dokončení studie (Aktuální)
1. února 2014
Termíny zápisu do studia
První předloženo
21. března 2013
První předloženo, které splnilo kritéria kontroly kvality
21. března 2013
První zveřejněno (Odhad)
25. března 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
9. ledna 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. listopadu 2016
Naposledy ověřeno
1. listopadu 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 116086
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studijní data/dokumenty
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Formulář komentované zprávy o případu
Identifikátor informace: 116086Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Zpráva o klinické studii
Identifikátor informace: 116086Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Soubor dat jednotlivých účastníků
Identifikátor informace: 116086Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Formulář informovaného souhlasu
Identifikátor informace: 116086Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Protokol studie
Identifikátor informace: 116086Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Specifikace datové sady
Identifikátor informace: 116086Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Plán statistické analýzy
Identifikátor informace: 116086Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .