CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
perjantai 20. maaliskuuta 2015 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Todellinen)
2515
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
-
Kozani, Kreikka
- Research Site
-
N. Efkarpia, Kreikka
- Research Site
-
Thessaloniki, Kreikka
- Research Site
-
Veroia, Kreikka
- Research Site
-
-
-
-
-
Toul Cedex, Ranska
- Research Site
-
-
-
-
-
Angelholm, Ruotsi
- Research Site
-
Angered, Ruotsi
- Research Site
-
Dalby, Ruotsi
- Research Site
-
Falun, Ruotsi
- Research Site
-
Goteborg, Ruotsi
- Research Site
-
Limhamn, Ruotsi
- Research Site
-
Lulea, Ruotsi
- Research Site
-
Malmo, Ruotsi
- Research Site
-
Skivarp, Ruotsi
- Research Site
-
Skovde, Ruotsi
- Research Site
-
Stockholm, Ruotsi
- Research Site
-
Vadstena, Ruotsi
- Research Site
-
Vastervik, Ruotsi
- Research Site
-
-
-
-
-
Alsfeld, Saksa
- Research Site
-
Aschaffenburg, Saksa
- Research
-
Asslar, Saksa
- Research Site
-
Augsburg, Saksa
- Research Site
-
Bad Aibling, Saksa
- Research Site
-
Bad Homburg, Saksa
- Research Site
-
Bad Mergentheim, Saksa
- Research Site
-
Bergheim, Saksa
- Research Site
-
Berlin, Saksa
- Research Site
-
Birkenfeld, Saksa
- Research
-
Bosenheim, Saksa
- Research Site
-
Bruchsal, Saksa
- Research Site
-
Dortmund, Saksa
- Research Site
-
Dresden, Saksa
- Research Site
-
Duisburg, Saksa
- Research Site
-
Eberswalde, Saksa
- Research Site
-
Eilenburg, Saksa
- Research Site
-
Eisenach, Saksa
- Research Site
-
Erfurt, Saksa
- Research Site
-
Essen, Saksa
- Research Site
-
Frankfurt, Saksa
- Research Site
-
Gebhardshain, Saksa
- Research Site
-
Gersfeld, Saksa
- Research Site
-
Giessen, Saksa
- Research Site
-
Gifhorn, Saksa
- Research Site
-
Grassau, Saksa
- Research Site
-
Gross-Gerau, Saksa
- Research Site
-
Hadmersleben, Saksa
- Research Site
-
Halle, Saksa
- Research Site
-
Hamburg, Saksa
- Research Site
-
Hammelburg, Saksa
- Research Site
-
Hennigsdorf, Saksa
- Research Site
-
Hohenmolsen, Saksa
- Research Site
-
Ismaning, Saksa
- Research Site
-
Kothen, Saksa
- Research Site
-
Kutenholz, Saksa
- Research Site
-
Langen, Saksa
- Research Site
-
Langenfeld, Saksa
- Research Site
-
Leipzig, Saksa
- Research Site
-
Lichtenfels, Saksa
- Research Site
-
Ludwigsburg, Saksa
- Research Site
-
Luneburg, Saksa
- Research Site
-
Marburg, Saksa
- Research Site
-
Mayen, Saksa
- Research Site
-
Meissen, Saksa
- Research Site
-
Minden, Saksa
- Research Site
-
Monchengladbach, Saksa
- Research Site
-
Munchen, Saksa
- Research Site
-
Munster, Saksa
- Research Site
-
Nassau, Saksa
- Research Site
-
Netphen, Saksa
- Research Site
-
Oberhausen, Saksa
- Research Site
-
Pirmasens, Saksa
- Research Site
-
Recklinghausen, Saksa
- Research Site
-
Rehburg-Loccum, Saksa
- Research Site
-
Reichenbach, Saksa
- Research Site
-
Riesa, Saksa
- Research Site
-
Saarbrucken, Saksa
- Research Site
-
Saarlouis, Saksa
- Research Site
-
Schkeuditz, Saksa
- Research Site
-
Schonwalde, Saksa
- Research Site
-
Schweinfurt, Saksa
- Research Site
-
Seligenstadt, Saksa
- Research Site
-
Siegen, Saksa
- Research Site
-
Stockach, Saksa
- Research Site
-
Thale, Saksa
- Research Site
-
Ubach-Palenberg, Saksa
- Research Site
-
Ueckermunde, Saksa
- Research Site
-
Villingen-Schwenningen, Saksa
- Research Site
-
Volklingen, Saksa
- Research Site
-
Warburg, Saksa
- Research Site
-
Weissenberg, Saksa
- Research Site
-
Werl, Saksa
- Research Site
-
Westfalica, Saksa
- Research Site
-
Wilhelmshaven, Saksa
- Research Site
-
Wurzen, Saksa
- Research Site
-
-
-
-
-
Amager, Tanska
- Research Site
-
Ronne, Tanska
- Research Site
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
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.
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
1
exenatide
|
ihonalainen injektio, 5 mikrogrammaa tai 10 mikrogrammaa kahdesti päivässä
Muut nimet:
|
|
2
insulin
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
Aikaikkuna: 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:
Exenatide:
|
Month 24
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline, Month 24
|
Changes in Weight From Baseline to Month 24
|
Baseline, Month 24
|
|
Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
Aikaikkuna: 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
Aikaikkuna: Baseline to Month 24
|
Incidence of Hypoglycemia between Baseline and 24 Months
|
Baseline to Month 24
|
|
Reasons for Discontinuation of Baseline Regimen
Aikaikkuna: Baseline to Month 24
|
Reasons for Discontinuation of Baseline Regimen
|
Baseline to Month 24
|
|
Factors Associated With Treatment Change in Insulin Cohort
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline to Month 24
|
Percentage of Patients Hospitalized Between Baseline and 24 Months
|
Baseline to Month 24
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojohtaja: James Malone, MD, Eli Lilly and Company
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Tiistai 1. tammikuuta 2008
Ensisijainen valmistuminen (Todellinen)
Torstai 1. joulukuuta 2011
Opintojen valmistuminen (Todellinen)
Torstai 1. joulukuuta 2011
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 20. helmikuuta 2008
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 12. maaliskuuta 2008
Ensimmäinen Lähetetty (Arvio)
Torstai 13. maaliskuuta 2008
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Torstai 9. huhtikuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 20. maaliskuuta 2015
Viimeksi vahvistettu
Sunnuntai 1. maaliskuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Glukoosiaineenvaihduntahäiriöt
- Metaboliset sairaudet
- Endokriinisen järjestelmän sairaudet
- Diabetes mellitus
- Diabetes mellitus, tyyppi 2
- Hypoglykeemiset aineet
- Huumeiden fysiologiset vaikutukset
- Hormonit
- Hormonit, hormonikorvikkeet ja hormoniantagonistit
- Liikalihavuuden vastaiset aineet
- Inkretiinit
- Insuliini
- Insuliini, Globiini Sinkki
- Eksenatidi
Muut tutkimustunnusnumerot
- H8O-EW-B005
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .