An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
18 novembre 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
31
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in HbA1c Values at Week 28
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mean Percent Compliance Throughout the Interventional Phase
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2013
Completamento primario (Effettivo)
1 febbraio 2014
Completamento dello studio (Effettivo)
1 febbraio 2014
Date di iscrizione allo studio
Primo inviato
21 marzo 2013
Primo inviato che soddisfa i criteri di controllo qualità
21 marzo 2013
Primo Inserito (Stima)
25 marzo 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
9 gennaio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 novembre 2016
Ultimo verificato
1 novembre 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 116086
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Dati/documenti di studio
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Modulo di segnalazione del caso annotato
Identificatore informazioni: 116086Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Rapporto di studio clinico
Identificatore informazioni: 116086Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Set di dati del singolo partecipante
Identificatore informazioni: 116086Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Modulo di consenso informato
Identificatore informazioni: 116086Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Protocollo di studio
Identificatore informazioni: 116086Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Specifica del set di dati
Identificatore informazioni: 116086Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Piano di analisi statistica
Identificatore informazioni: 116086Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .