CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
20 marca 2015 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
2515
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Amager, Dania
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Ronne, Dania
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Toul Cedex, Francja
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Kozani, Grecja
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N. Efkarpia, Grecja
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Thessaloniki, Grecja
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Veroia, Grecja
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Alsfeld, Niemcy
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Aschaffenburg, Niemcy
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Asslar, Niemcy
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Augsburg, Niemcy
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Bad Aibling, Niemcy
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Bad Homburg, Niemcy
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Bad Mergentheim, Niemcy
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Bergheim, Niemcy
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Berlin, Niemcy
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Birkenfeld, Niemcy
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Bosenheim, Niemcy
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Bruchsal, Niemcy
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Dortmund, Niemcy
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Dresden, Niemcy
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Duisburg, Niemcy
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Eberswalde, Niemcy
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Eilenburg, Niemcy
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Eisenach, Niemcy
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Erfurt, Niemcy
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Essen, Niemcy
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Frankfurt, Niemcy
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Gebhardshain, Niemcy
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Gersfeld, Niemcy
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Giessen, Niemcy
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Gifhorn, Niemcy
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Grassau, Niemcy
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Gross-Gerau, Niemcy
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Hadmersleben, Niemcy
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Halle, Niemcy
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Hamburg, Niemcy
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Hammelburg, Niemcy
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Hennigsdorf, Niemcy
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Hohenmolsen, Niemcy
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Ismaning, Niemcy
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Kothen, Niemcy
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Kutenholz, Niemcy
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Langen, Niemcy
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Langenfeld, Niemcy
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Leipzig, Niemcy
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Lichtenfels, Niemcy
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Ludwigsburg, Niemcy
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Luneburg, Niemcy
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Marburg, Niemcy
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Mayen, Niemcy
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Meissen, Niemcy
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Minden, Niemcy
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Monchengladbach, Niemcy
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Munchen, Niemcy
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Munster, Niemcy
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Nassau, Niemcy
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Netphen, Niemcy
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Oberhausen, Niemcy
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Pirmasens, Niemcy
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Recklinghausen, Niemcy
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Rehburg-Loccum, Niemcy
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Reichenbach, Niemcy
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Riesa, Niemcy
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Saarbrucken, Niemcy
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Saarlouis, Niemcy
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Schkeuditz, Niemcy
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Schonwalde, Niemcy
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Schweinfurt, Niemcy
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Seligenstadt, Niemcy
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Siegen, Niemcy
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Stockach, Niemcy
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Thale, Niemcy
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Ubach-Palenberg, Niemcy
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Ueckermunde, Niemcy
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Villingen-Schwenningen, Niemcy
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Volklingen, Niemcy
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Warburg, Niemcy
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Weissenberg, Niemcy
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Werl, Niemcy
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Westfalica, Niemcy
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Wilhelmshaven, Niemcy
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Wurzen, Niemcy
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Angelholm, Szwecja
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Angered, Szwecja
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Dalby, Szwecja
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Falun, Szwecja
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Goteborg, Szwecja
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Limhamn, Szwecja
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Lulea, Szwecja
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Malmo, Szwecja
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Skivarp, Szwecja
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Skovde, Szwecja
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Stockholm, Szwecja
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Vadstena, Szwecja
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Vastervik, Szwecja
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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.
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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1
exenatide
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wstrzyknięcie podskórne, 5 mcg lub 10 mcg, dwa razy dziennie
Inne nazwy:
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2
insulin
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: James Malone, MD, Eli Lilly and Company
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 stycznia 2008
Zakończenie podstawowe (Rzeczywisty)
1 grudnia 2011
Ukończenie studiów (Rzeczywisty)
1 grudnia 2011
Daty rejestracji na studia
Pierwszy przesłany
20 lutego 2008
Pierwszy przesłany, który spełnia kryteria kontroli jakości
12 marca 2008
Pierwszy wysłany (Oszacować)
13 marca 2008
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
9 kwietnia 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
20 marca 2015
Ostatnia weryfikacja
1 marca 2015
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- H8O-EW-B005
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .