Clinical trial NCT00635492: CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
insulin
exenatide
Byetta
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2008-03-13
Enrollment: 2515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
timeFrame: Month 24
Secondary outcomes:
measure: Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
timeFrame: Baseline
measure: Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline
timeFrame: Baseline
measure: Older Age Associated With Treatment Choice at Baseline
timeFrame: Baseline
measure: Disinhibited Eating Associated With Treatment Choice at Baseline
timeFrame: Baseline
measure: Higher Random Glucose Associated With Treatment Choice at Baseline
timeFrame: 6 months prior to Baseline
measure: Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline
timeFrame: 4 weeks prior to Baseline
measure: Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline
timeFrame: Baseline
measure: Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline
timeFrame: Baseline
measure: Changes in HbA1c From Baseline to Month 24
timeFrame: Baseline, Month 24
measure: Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24
timeFrame: Month 24
measure: Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24
timeFrame: Month 24
measure: Changes in Weight From Baseline to Month 24
timeFrame: Baseline, Month 24
measure: Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
timeFrame: Baseline to Month 24
measure: Incidence of Hypoglycemia Between Baseline and 24 Months
timeFrame: Baseline to Month 24
measure: Reasons for Discontinuation of Baseline Regimen
timeFrame: Baseline to Month 24
measure: Factors Associated With Treatment Change in Insulin Cohort
timeFrame: Baseline to Month 24
measure: Factors Associated With Treatment Change in Exenatide BID Cohort
timeFrame: Baseline to Month 24
measure: Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
timeFrame: Baseline to Month 24
measure: Number of Contacts With Health Care Providers Between Baseline and 24 Months
timeFrame: Baseline to Month 24
measure: Percentage of Patients Hospitalized Between Baseline and 24 Months
timeFrame: Baseline to Month 24
Other outcomes:
Locations:
city: Amager
country: Denmark
facility: Research Site
city: Ronne
country: Denmark
facility: Research Site
city: Toul Cedex
country: France
facility: Research Site
city: Alsfeld
country: Germany
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research
city: Asslar
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bad Aibling
country: Germany
facility: Research Site
city: Bad Homburg
country: Germany
facility: Research Site
city: Bad Mergentheim
country: Germany
facility: Research Site
city: Bergheim
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Birkenfeld
country: Germany
facility: Research
city: Bosenheim
country: Germany
facility: Research Site
city: Bruchsal
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Duisburg
country: Germany
facility: Research Site
city: Eberswalde
country: Germany
facility: Research Site
city: Eilenburg
country: Germany
facility: Research Site
city: Eisenach
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Gebhardshain
country: Germany
facility: Research Site
city: Gersfeld
country: Germany
facility: Research Site
city: Giessen
country: Germany
facility: Research Site
city: Gifhorn
country: Germany
facility: Research Site
city: Grassau
country: Germany
facility: Research Site
city: Gross-Gerau
country: Germany
facility: Research Site
city: Hadmersleben
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hammelburg
country: Germany
facility: Research Site
city: Hennigsdorf
country: Germany
facility: Research Site
city: Hohenmolsen
country: Germany
facility: Research Site
city: Ismaning
country: Germany
facility: Research Site
city: Kothen
country: Germany
facility: Research Site
city: Kutenholz
country: Germany
facility: Research Site
city: Langenfeld
country: Germany
facility: Research Site
city: Langen
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Lichtenfels
country: Germany
facility: Research Site
city: Ludwigsburg
country: Germany
facility: Research Site
city: Luneburg
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Mayen
country: Germany
facility: Research Site
city: Meissen
country: Germany
facility: Research Site
city: Minden
country: Germany
facility: Research Site
city: Monchengladbach
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Nassau
country: Germany
facility: Research Site
city: Netphen
country: Germany
facility: Research Site
city: Oberhausen
country: Germany
facility: Research Site
city: Pirmasens
country: Germany
facility: Research Site
city: Recklinghausen
country: Germany
facility: Research Site
city: Rehburg-Loccum
country: Germany
facility: Research Site
city: Reichenbach
country: Germany
facility: Research Site
city: Riesa
country: Germany
facility: Research Site
city: Saarbrucken
country: Germany
facility: Research Site
city: Saarlouis
country: Germany
facility: Research Site
city: Schkeuditz
country: Germany
facility: Research Site
city: Schonwalde
country: Germany
facility: Research Site
city: Schweinfurt
country: Germany
facility: Research Site
city: Seligenstadt
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Stockach
country: Germany
facility: Research Site
city: Thale
country: Germany
facility: Research Site
city: Ubach-Palenberg
country: Germany
facility: Research Site
city: Ueckermunde
country: Germany
facility: Research Site
city: Villingen-Schwenningen
country: Germany
facility: Research Site
city: Volklingen
country: Germany
facility: Research Site
city: Warburg
country: Germany
facility: Research Site
city: Weissenberg
country: Germany
facility: Research Site
city: Werl
country: Germany
facility: Research Site
city: Westfalica
country: Germany
facility: Research Site
city: Wilhelmshaven
country: Germany
facility: Research Site
city: Wurzen
country: Germany
facility: Research Site
city: Kozani
country: Greece
facility: Research Site
city: N. Efkarpia
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Veroia
country: Greece
facility: Research Site
city: Angelholm
country: Sweden
facility: Research Site
city: Angered
country: Sweden
facility: Research Site
city: Dalby
country: Sweden
facility: Research Site
city: Falun
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Limhamn
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Skivarp
country: Sweden
facility: Research Site
city: Skovde
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Vadstena
country: Sweden
facility: Research Site
city: Vastervik
country: Sweden
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: James Malone, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.