CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
20 de março de 2015 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
2515
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alsfeld, Alemanha
- Research Site
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Aschaffenburg, Alemanha
- Research
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Asslar, Alemanha
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Augsburg, Alemanha
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Bad Aibling, Alemanha
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Bad Homburg, Alemanha
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Bad Mergentheim, Alemanha
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Bergheim, Alemanha
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Berlin, Alemanha
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Birkenfeld, Alemanha
- Research
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Bosenheim, Alemanha
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Bruchsal, Alemanha
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Dortmund, Alemanha
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Dresden, Alemanha
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Duisburg, Alemanha
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Eberswalde, Alemanha
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Eilenburg, Alemanha
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Eisenach, Alemanha
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Erfurt, Alemanha
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Essen, Alemanha
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Frankfurt, Alemanha
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Gebhardshain, Alemanha
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Gersfeld, Alemanha
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Giessen, Alemanha
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Gifhorn, Alemanha
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Grassau, Alemanha
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Gross-Gerau, Alemanha
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Hadmersleben, Alemanha
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Halle, Alemanha
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Hamburg, Alemanha
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Hammelburg, Alemanha
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Hennigsdorf, Alemanha
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Hohenmolsen, Alemanha
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Ismaning, Alemanha
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Kothen, Alemanha
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Kutenholz, Alemanha
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Langen, Alemanha
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Langenfeld, Alemanha
- Research Site
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Leipzig, Alemanha
- Research Site
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Lichtenfels, Alemanha
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Ludwigsburg, Alemanha
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Luneburg, Alemanha
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Marburg, Alemanha
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Mayen, Alemanha
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Meissen, Alemanha
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Minden, Alemanha
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Monchengladbach, Alemanha
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Munchen, Alemanha
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Munster, Alemanha
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Nassau, Alemanha
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Netphen, Alemanha
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Oberhausen, Alemanha
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Pirmasens, Alemanha
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Recklinghausen, Alemanha
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Rehburg-Loccum, Alemanha
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Reichenbach, Alemanha
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Riesa, Alemanha
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Saarbrucken, Alemanha
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Saarlouis, Alemanha
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Schkeuditz, Alemanha
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Schonwalde, Alemanha
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Schweinfurt, Alemanha
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Seligenstadt, Alemanha
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Siegen, Alemanha
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Stockach, Alemanha
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Thale, Alemanha
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Ubach-Palenberg, Alemanha
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Ueckermunde, Alemanha
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Villingen-Schwenningen, Alemanha
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Volklingen, Alemanha
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Warburg, Alemanha
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Weissenberg, Alemanha
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Werl, Alemanha
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Westfalica, Alemanha
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Wilhelmshaven, Alemanha
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Wurzen, Alemanha
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Amager, Dinamarca
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Ronne, Dinamarca
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Toul Cedex, França
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Kozani, Grécia
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N. Efkarpia, Grécia
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Thessaloniki, Grécia
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Veroia, Grécia
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Angelholm, Suécia
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Angered, Suécia
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Dalby, Suécia
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Falun, Suécia
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Goteborg, Suécia
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Limhamn, Suécia
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Lulea, Suécia
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Malmo, Suécia
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Skivarp, Suécia
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Skovde, Suécia
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Stockholm, Suécia
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Vadstena, Suécia
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Vastervik, Suécia
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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1
exenatide
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injeção subcutânea, 5mcg ou 10mcg, duas vezes ao dia
Outros nomes:
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2
insulin
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
Prazo: Month 24
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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:
Exenatide:
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Month 24
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Prazo: Baseline
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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).
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Baseline
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Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline
Prazo: Baseline
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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.
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Baseline
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Older Age Associated With Treatment Choice at Baseline
Prazo: Baseline
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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).
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Baseline
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Disinhibited Eating Associated With Treatment Choice at Baseline
Prazo: Baseline
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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).
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Baseline
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Higher Random Glucose Associated With Treatment Choice at Baseline
Prazo: 6 months prior to Baseline
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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).
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6 months prior to Baseline
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Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline
Prazo: 4 weeks prior to Baseline
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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).
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4 weeks prior to Baseline
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Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline
Prazo: Baseline
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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).
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Baseline
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Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline
Prazo: Baseline
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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).
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Baseline
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Changes in HbA1c From Baseline to Month 24
Prazo: Baseline, Month 24
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Changes in HbA1c From Baseline to Month 24
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Baseline, Month 24
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Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24
Prazo: Month 24
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Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24.
Only patients with baseline HbA1c >= 7.0 % were included in this analysis
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Month 24
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Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24
Prazo: Month 24
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Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24.
Note: Only patients with baseline HbA1c >=6.5% were included in this analysis.
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Month 24
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Changes in Weight From Baseline to Month 24
Prazo: Baseline, Month 24
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Changes in Weight From Baseline to Month 24
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Baseline, Month 24
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Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
Prazo: Baseline to Month 24
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Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months
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Baseline to Month 24
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Incidence of Hypoglycemia Between Baseline and 24 Months
Prazo: Baseline to Month 24
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Incidence of Hypoglycemia between Baseline and 24 Months
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Baseline to Month 24
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Reasons for Discontinuation of Baseline Regimen
Prazo: Baseline to Month 24
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Reasons for Discontinuation of Baseline Regimen
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Baseline to Month 24
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Factors Associated With Treatment Change in Insulin Cohort
Prazo: Baseline to Month 24
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Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort
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Baseline to Month 24
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Factors Associated With Treatment Change in Exenatide BID Cohort
Prazo: Baseline to Month 24
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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).
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Baseline to Month 24
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Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
Prazo: Baseline to Month 24
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Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
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Baseline to Month 24
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Number of Contacts With Health Care Providers Between Baseline and 24 Months
Prazo: Baseline to Month 24
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Number of contacts with Health Care Providers Between Baseline and 24 Months
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Baseline to Month 24
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Percentage of Patients Hospitalized Between Baseline and 24 Months
Prazo: Baseline to Month 24
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Percentage of Patients Hospitalized Between Baseline and 24 Months
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Baseline to Month 24
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: James Malone, MD, Eli Lilly and Company
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Schultheis P, Montoya MN, Zhao Q, Archer J, Madden T, Peipert JF. Contraception and ectopic pregnancy risk: a prospective observational analysis. Am J Obstet Gynecol. 2021 Feb;224(2):228-229. doi: 10.1016/j.ajog.2020.10.013. Epub 2020 Oct 10. No abstract available.
- Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljanski J, Salaun-Martin C, Sapin H, Theodorakis M, Guerci B. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study. Health Qual Life Outcomes. 2013 Dec 26;11:217. doi: 10.1186/1477-7525-11-217.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2008
Conclusão Primária (Real)
1 de dezembro de 2011
Conclusão do estudo (Real)
1 de dezembro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
20 de fevereiro de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de março de 2008
Primeira postagem (Estimativa)
13 de março de 2008
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
9 de abril de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de março de 2015
Última verificação
1 de março de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Doenças do Sistema Endócrino
- Diabetes Mellitus
- Diabetes Mellitus, Tipo 2
- Hipoglicemiantes
- Efeitos Fisiológicos das Drogas
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Agentes Anti-Obesidade
- Incretinas
- Insulina
- Insulina, Globina Zinco
- Exenatida
Outros números de identificação do estudo
- H8O-EW-B005
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .