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An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes

18 de noviembre de 2016 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

31

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Argentina
      • Correintes, Argentina
        • GSK Investigational Site
      • Corrientes, Argentina
        • GSK Investigational Site
      • Mendoza, Argentina, 5515
        • GSK Investigational Site
      • Mendoza, Argentina, 5539
        • GSK Investigational Site
      • Mendoza, Argentina
        • GSK Investigational Site
      • Provincia de Buenos Aires, Argentina, 1754
        • GSK Investigational Site
      • Tucumán, Argentina, T 4000IOE
        • GSK Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: Metformin Small Pack
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.
Experimental: 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.
Droga: Metformin Large Pack
The large pack will consist of 1 month's supply of metformin.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in HbA1c Values at Week 28
Periodo de tiempo: Baseline (Week 8) and Week 28
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).
Baseline (Week 8) and Week 28

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Percent Compliance Throughout the Interventional Phase
Periodo de tiempo: From Randomization to Week 28
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.
From Randomization to Week 28
Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase
Periodo de tiempo: From enrollment to Week 8
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.
From enrollment to Week 8
Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days
Periodo de tiempo: Week 28
The number of days on which no metformin pills were taken by participants was summarized.
Week 28
Number of Participants With Diabetes Disease Management Modifications
Periodo de tiempo: Week 28
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.
Week 28
Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes
Periodo de tiempo: Week 28
The number of participants who visited a health care professional for diabetes management during the study was summarized.
Week 28
Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication
Periodo de tiempo: Week 28
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.
Week 28
Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons
Periodo de tiempo: Week 28
The number of particiapnts who missed days or doses of metformin was summarized.
Week 28
Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up
Periodo de tiempo: Week 28
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.
Week 28

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2013

Finalización primaria (Actual)

1 de febrero de 2014

Finalización del estudio (Actual)

1 de febrero de 2014

Fechas de registro del estudio

Enviado por primera vez

21 de marzo de 2013

Primero enviado que cumplió con los criterios de control de calidad

21 de marzo de 2013

Publicado por primera vez (Estimar)

25 de marzo de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

9 de enero de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

18 de noviembre de 2016

Última verificación

1 de noviembre de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 116086

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Datos del estudio/Documentos

  1. Formulario de informe de caso anotado
    Identificador de información: 116086
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informe de estudio clínico
    Identificador de información: 116086
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Conjunto de datos de participantes individuales
    Identificador de información: 116086
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Formulario de consentimiento informado
    Identificador de información: 116086
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocolo de estudio
    Identificador de información: 116086
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  6. Especificación del conjunto de datos
    Identificador de información: 116086
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  7. Plan de Análisis Estadístico
    Identificador de información: 116086
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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