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

20 mars 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Réel)

2515

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
1
exenatide
Médicament: exénatide
injection sous-cutanée, 5mcg ou 10mcg, deux fois par jour
Autres noms:
  • Byetta
2
insulin
Médicament: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline, Month 24
Changes in Weight From Baseline to Month 24
Baseline, Month 24
Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
Délai: 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
Délai: Baseline to Month 24
Incidence of Hypoglycemia between Baseline and 24 Months
Baseline to Month 24
Reasons for Discontinuation of Baseline Regimen
Délai: Baseline to Month 24
Reasons for Discontinuation of Baseline Regimen
Baseline to Month 24
Factors Associated With Treatment Change in Insulin Cohort
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline to Month 24
Percentage of Patients Hospitalized Between Baseline and 24 Months
Baseline to Month 24

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AstraZeneca

Collaborateurs

Eli Lilly and Company

Les enquêteurs

  • Directeur d'études: James Malone, MD, Eli Lilly and Company

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2008

Achèvement primaire (Réel)

1 décembre 2011

Achèvement de l'étude (Réel)

1 décembre 2011

Dates d'inscription aux études

Première soumission

20 février 2008

Première soumission répondant aux critères de contrôle qualité

12 mars 2008

Première publication (Estimation)

13 mars 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

9 avril 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 mars 2015

Dernière vérification

1 mars 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • H8O-EW-B005

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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