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

20 марта 2015 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Наблюдательный

Регистрация (Действительный)

2515

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
1
exenatide
Лекарство: эксенатид
подкожно, 5 мкг или 10 мкг 2 раза в день
Другие имена:
  • Байетта
2
insulin
Лекарство: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline, Month 24
Changes in Weight From Baseline to Month 24
Baseline, Month 24
Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
Временное ограничение: 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
Временное ограничение: Baseline to Month 24
Incidence of Hypoglycemia between Baseline and 24 Months
Baseline to Month 24
Reasons for Discontinuation of Baseline Regimen
Временное ограничение: Baseline to Month 24
Reasons for Discontinuation of Baseline Regimen
Baseline to Month 24
Factors Associated With Treatment Change in Insulin Cohort
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline to Month 24
Percentage of Patients Hospitalized Between Baseline and 24 Months
Baseline to Month 24

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

AstraZeneca

Соавторы

Eli Lilly and Company

Следователи

  • Директор по исследованиям: James Malone, MD, Eli Lilly and Company

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 января 2008 г.

Первичное завершение (Действительный)

1 декабря 2011 г.

Завершение исследования (Действительный)

1 декабря 2011 г.

Даты регистрации исследования

Первый отправленный

20 февраля 2008 г.

Впервые представлено, что соответствует критериям контроля качества

12 марта 2008 г.

Первый опубликованный (Оценивать)

13 марта 2008 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

9 апреля 2015 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

20 марта 2015 г.

Последняя проверка

1 марта 2015 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • H8O-EW-B005

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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