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

20. März 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

2515

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
1
exenatide
Arzneimittel: Exenatid
subkutane Injektion, 5 µg oder 10 µg, zweimal täglich
Andere Namen:
  • Byetta
2
insulin
Arzneimittel: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AstraZeneca

Mitarbeiter

Eli Lilly and Company

Ermittler

  • Studienleiter: James Malone, MD, Eli Lilly and Company

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2008

Primärer Abschluss (Tatsächlich)

1. Dezember 2011

Studienabschluss (Tatsächlich)

1. Dezember 2011

Studienanmeldedaten

Zuerst eingereicht

20. Februar 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. März 2008

Zuerst gepostet (Schätzen)

13. März 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

9. April 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. März 2015

Zuletzt verifiziert

1. März 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H8O-EW-B005

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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