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

20 maart 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Werkelijk)

2515

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
1
exenatide
Geneesmiddel: exenatide
subcutane injectie, 5mcg of 10mcg, tweemaal per dag
Andere namen:
  • Byetta
2
insulin
Geneesmiddel: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Medewerkers

Eli Lilly and Company

Onderzoekers

  • Studie directeur: James Malone, MD, Eli Lilly and Company

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2008

Primaire voltooiing (Werkelijk)

1 december 2011

Studie voltooiing (Werkelijk)

1 december 2011

Studieregistratiedata

Eerst ingediend

20 februari 2008

Eerst ingediend dat voldeed aan de QC-criteria

12 maart 2008

Eerst geplaatst (Schatting)

13 maart 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

9 april 2015

Laatste update ingediend die voldeed aan QC-criteria

20 maart 2015

Laatst geverifieerd

1 maart 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • H8O-EW-B005

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Voorwaarden

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Locaties

3
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