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CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy

20 de marzo de 2015 actualizado por: AstraZeneca

CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months

Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Actual)

2515

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

  • Alemania
      • Alsfeld, Alemania
        • Research Site
      • Aschaffenburg, Alemania
        • Research
      • Asslar, Alemania
        • Research Site
      • Augsburg, Alemania
        • Research Site
      • Bad Aibling, Alemania
        • Research Site
      • Bad Homburg, Alemania
        • Research Site
      • Bad Mergentheim, Alemania
        • Research Site
      • Bergheim, Alemania
        • Research Site
      • Berlin, Alemania
        • Research Site
      • Birkenfeld, Alemania
        • Research
      • Bosenheim, Alemania
        • Research Site
      • Bruchsal, Alemania
        • Research Site
      • Dortmund, Alemania
        • Research Site
      • Dresden, Alemania
        • Research Site
      • Duisburg, Alemania
        • Research Site
      • Eberswalde, Alemania
        • Research Site
      • Eilenburg, Alemania
        • Research Site
      • Eisenach, Alemania
        • Research Site
      • Erfurt, Alemania
        • Research Site
      • Essen, Alemania
        • Research Site
      • Frankfurt, Alemania
        • Research Site
      • Gebhardshain, Alemania
        • Research Site
      • Gersfeld, Alemania
        • Research Site
      • Giessen, Alemania
        • Research Site
      • Gifhorn, Alemania
        • Research Site
      • Grassau, Alemania
        • Research Site
      • Gross-Gerau, Alemania
        • Research Site
      • Hadmersleben, Alemania
        • Research Site
      • Halle, Alemania
        • Research Site
      • Hamburg, Alemania
        • Research Site
      • Hammelburg, Alemania
        • Research Site
      • Hennigsdorf, Alemania
        • Research Site
      • Hohenmolsen, Alemania
        • Research Site
      • Ismaning, Alemania
        • Research Site
      • Kothen, Alemania
        • Research Site
      • Kutenholz, Alemania
        • Research Site
      • Langen, Alemania
        • Research Site
      • Langenfeld, Alemania
        • Research Site
      • Leipzig, Alemania
        • Research Site
      • Lichtenfels, Alemania
        • Research Site
      • Ludwigsburg, Alemania
        • Research Site
      • Luneburg, Alemania
        • Research Site
      • Marburg, Alemania
        • Research Site
      • Mayen, Alemania
        • Research Site
      • Meissen, Alemania
        • Research Site
      • Minden, Alemania
        • Research Site
      • Monchengladbach, Alemania
        • Research Site
      • Munchen, Alemania
        • Research Site
      • Munster, Alemania
        • Research Site
      • Nassau, Alemania
        • Research Site
      • Netphen, Alemania
        • Research Site
      • Oberhausen, Alemania
        • Research Site
      • Pirmasens, Alemania
        • Research Site
      • Recklinghausen, Alemania
        • Research Site
      • Rehburg-Loccum, Alemania
        • Research Site
      • Reichenbach, Alemania
        • Research Site
      • Riesa, Alemania
        • Research Site
      • Saarbrucken, Alemania
        • Research Site
      • Saarlouis, Alemania
        • Research Site
      • Schkeuditz, Alemania
        • Research Site
      • Schonwalde, Alemania
        • Research Site
      • Schweinfurt, Alemania
        • Research Site
      • Seligenstadt, Alemania
        • Research Site
      • Siegen, Alemania
        • Research Site
      • Stockach, Alemania
        • Research Site
      • Thale, Alemania
        • Research Site
      • Ubach-Palenberg, Alemania
        • Research Site
      • Ueckermunde, Alemania
        • Research Site
      • Villingen-Schwenningen, Alemania
        • Research Site
      • Volklingen, Alemania
        • Research Site
      • Warburg, Alemania
        • Research Site
      • Weissenberg, Alemania
        • Research Site
      • Werl, Alemania
        • Research Site
      • Westfalica, Alemania
        • Research Site
      • Wilhelmshaven, Alemania
        • Research Site
      • Wurzen, Alemania
        • Research Site
  • Dinamarca
      • Amager, Dinamarca
        • Research Site
      • Ronne, Dinamarca
        • Research Site
  • Francia
      • Toul Cedex, Francia
        • Research Site
  • Grecia
      • Kozani, Grecia
        • Research Site
      • N. Efkarpia, Grecia
        • Research Site
      • Thessaloniki, Grecia
        • Research Site
      • Veroia, Grecia
        • Research Site
  • Suecia
      • Angelholm, Suecia
        • Research Site
      • Angered, Suecia
        • Research Site
      • Dalby, Suecia
        • Research Site
      • Falun, Suecia
        • Research Site
      • Goteborg, Suecia
        • Research Site
      • Limhamn, Suecia
        • Research Site
      • Lulea, Suecia
        • Research Site
      • Malmo, Suecia
        • Research Site
      • Skivarp, Suecia
        • Research Site
      • Skovde, Suecia
        • Research Site
      • Stockholm, Suecia
        • Research Site
      • Vadstena, Suecia
        • Research Site
      • Vastervik, Suecia
        • Research 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

Método de muestreo

Muestra no probabilística

Población de estudio

The study population consisted of patients aged 18 or above, with type 2 diabetes starting any of the available initial injectable treatment options (any insulin, or exenatide BID) for the treatment of type 2 diabetes as part of routine clinical care.

Descripción

Inclusion Criteria:

  • are aged 18 or above
  • diagnosed with type 2 diabetes
  • have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes
  • have not previously been treated with either insulin or exenatide
  • are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
  • have been fully informed and given their written consent for use of their data
  • have sufficient understanding of the primary language of their country such that they will be able to complete the questionnaires.

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
1
exenatide
Droga: exenatida
inyección subcutánea, 5 mcg o 10 mcg, dos veces al día
Otros nombres:
  • Byetta
2
insulin
Droga: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
Periodo de tiempo: Month 24

The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time.

Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.

Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:

Insulin:

  • Addition of a new medication for the treatment of type 2 diabetes
  • A change in the number of times insulin is administered per day
  • Discontinuation of any insulin initiated at baseline
  • Substitution of a human insulin for an analogue insulin or vice-versa.
  • Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.

Exenatide:

  • Addition of a new medication for the treatment of type 2 diabetes
  • Discontinuation of exenatide.
Month 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Periodo de tiempo: Baseline
Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Baseline
Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline
Periodo de tiempo: Baseline
Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.
Baseline
Older Age Associated With Treatment Choice at Baseline
Periodo de tiempo: Baseline
Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Baseline
Disinhibited Eating Associated With Treatment Choice at Baseline
Periodo de tiempo: Baseline
Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Baseline
Higher Random Glucose Associated With Treatment Choice at Baseline
Periodo de tiempo: 6 months prior to Baseline
Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
6 months prior to Baseline
Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline
Periodo de tiempo: 4 weeks prior to Baseline
Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
4 weeks prior to Baseline
Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline
Periodo de tiempo: Baseline
Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Baseline
Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline
Periodo de tiempo: Baseline
Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Baseline
Changes in HbA1c From Baseline to Month 24
Periodo de tiempo: Baseline, Month 24
Changes in HbA1c From Baseline to Month 24
Baseline, Month 24
Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24
Periodo de tiempo: Month 24
Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24. Only patients with baseline HbA1c >= 7.0 % were included in this analysis
Month 24
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24
Periodo de tiempo: Month 24
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24. Note: Only patients with baseline HbA1c >=6.5% were included in this analysis.
Month 24
Changes in Weight From Baseline to Month 24
Periodo de tiempo: Baseline, Month 24
Changes in Weight From Baseline to Month 24
Baseline, Month 24
Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
Periodo de tiempo: Baseline to Month 24
Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months
Baseline to Month 24
Incidence of Hypoglycemia Between Baseline and 24 Months
Periodo de tiempo: Baseline to Month 24
Incidence of Hypoglycemia between Baseline and 24 Months
Baseline to Month 24
Reasons for Discontinuation of Baseline Regimen
Periodo de tiempo: Baseline to Month 24
Reasons for Discontinuation of Baseline Regimen
Baseline to Month 24
Factors Associated With Treatment Change in Insulin Cohort
Periodo de tiempo: Baseline to Month 24
Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort
Baseline to Month 24
Factors Associated With Treatment Change in Exenatide BID Cohort
Periodo de tiempo: Baseline to Month 24
Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).
Baseline to Month 24
Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
Periodo de tiempo: Baseline to Month 24
Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
Baseline to Month 24
Number of Contacts With Health Care Providers Between Baseline and 24 Months
Periodo de tiempo: Baseline to Month 24
Number of contacts with Health Care Providers Between Baseline and 24 Months
Baseline to Month 24
Percentage of Patients Hospitalized Between Baseline and 24 Months
Periodo de tiempo: Baseline to Month 24
Percentage of Patients Hospitalized Between Baseline and 24 Months
Baseline to Month 24

Colaboradores e Investigadores

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

Patrocinador

AstraZeneca

Colaboradores

Eli Lilly and Company

Investigadores

  • Director de estudio: James Malone, MD, Eli Lilly and Company

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.

Publicaciones Generales

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 enero de 2008

Finalización primaria (Actual)

1 de diciembre de 2011

Finalización del estudio (Actual)

1 de diciembre de 2011

Fechas de registro del estudio

Enviado por primera vez

20 de febrero de 2008

Primero enviado que cumplió con los criterios de control de calidad

12 de marzo de 2008

Publicado por primera vez (Estimar)

13 de marzo de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

9 de abril de 2015

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

20 de marzo de 2015

Última verificación

1 de marzo de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • H8O-EW-B005

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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