CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
20. marts 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2515
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Amager, Danmark
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Ronne, Danmark
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Toul Cedex, Frankrig
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Kozani, Grækenland
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N. Efkarpia, Grækenland
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Thessaloniki, Grækenland
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Veroia, Grækenland
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Angelholm, Sverige
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Angered, Sverige
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Dalby, Sverige
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Falun, Sverige
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Goteborg, Sverige
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Limhamn, Sverige
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Lulea, Sverige
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Malmo, Sverige
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Skivarp, Sverige
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Skovde, Sverige
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Stockholm, Sverige
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Vadstena, Sverige
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Vastervik, Sverige
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Alsfeld, Tyskland
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Aschaffenburg, Tyskland
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Asslar, Tyskland
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Augsburg, Tyskland
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Bad Aibling, Tyskland
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Bad Homburg, Tyskland
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Bad Mergentheim, Tyskland
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Bergheim, Tyskland
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Berlin, Tyskland
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Birkenfeld, Tyskland
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Bosenheim, Tyskland
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Bruchsal, Tyskland
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Dortmund, Tyskland
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Dresden, Tyskland
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Duisburg, Tyskland
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Eberswalde, Tyskland
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Eilenburg, Tyskland
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Eisenach, Tyskland
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Erfurt, Tyskland
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Essen, Tyskland
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Frankfurt, Tyskland
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Gebhardshain, Tyskland
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Gersfeld, Tyskland
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Giessen, Tyskland
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Gifhorn, Tyskland
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Grassau, Tyskland
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Gross-Gerau, Tyskland
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Hadmersleben, Tyskland
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Halle, Tyskland
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Hamburg, Tyskland
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Hammelburg, Tyskland
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Hennigsdorf, Tyskland
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Hohenmolsen, Tyskland
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Ismaning, Tyskland
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Kothen, Tyskland
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Kutenholz, Tyskland
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Langen, Tyskland
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Langenfeld, Tyskland
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Leipzig, Tyskland
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Lichtenfels, Tyskland
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Ludwigsburg, Tyskland
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Luneburg, Tyskland
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Marburg, Tyskland
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Mayen, Tyskland
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Meissen, Tyskland
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Minden, Tyskland
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Monchengladbach, Tyskland
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Munchen, Tyskland
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Munster, Tyskland
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Nassau, Tyskland
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Netphen, Tyskland
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Oberhausen, Tyskland
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Pirmasens, Tyskland
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Recklinghausen, Tyskland
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Rehburg-Loccum, Tyskland
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Reichenbach, Tyskland
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Riesa, Tyskland
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Saarbrucken, Tyskland
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Saarlouis, Tyskland
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Schkeuditz, Tyskland
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Schonwalde, Tyskland
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Schweinfurt, Tyskland
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Seligenstadt, Tyskland
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Siegen, Tyskland
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Stockach, Tyskland
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Thale, Tyskland
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Ubach-Palenberg, Tyskland
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Ueckermunde, Tyskland
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Villingen-Schwenningen, Tyskland
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Volklingen, Tyskland
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Warburg, Tyskland
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Weissenberg, Tyskland
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Werl, Tyskland
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Westfalica, Tyskland
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Wilhelmshaven, Tyskland
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Wurzen, Tyskland
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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1
exenatide
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subkutan injektion, 5mcg eller 10mcg, to gange dagligt
Andre navne:
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2
insulin
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: James Malone, MD, Eli Lilly and Company
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2008
Primær færdiggørelse (Faktiske)
1. december 2011
Studieafslutning (Faktiske)
1. december 2011
Datoer for studieregistrering
Først indsendt
20. februar 2008
Først indsendt, der opfyldte QC-kriterier
12. marts 2008
Først opslået (Skøn)
13. marts 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. marts 2015
Sidst verificeret
1. marts 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes mellitus, type 2
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Midler mod fedme
- Inkretiner
- Insulin
- Insulin, Globin Zink
- Exenatid
Andre undersøgelses-id-numre
- H8O-EW-B005
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .