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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635492
• Other study ID #: H8O-EW-B005
• Status: Completed
• Phase: N/A
• First received: February 20, 2008
• Last updated: March 20, 2015
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthGermany: Ministry of HealthSweden: Medical Products Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2515
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
• any human insulin or analog insulin(s) given in any regimen by subcutaneous injection

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Greece,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.	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	No
Secondary	Higher Body Mass Index (BMI) Associated With Treatment Choice at 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	No
Secondary	Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at 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	No
Secondary	Older Age Associated With Treatment Choice at 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	No
Secondary	Disinhibited Eating Associated With Treatment Choice at 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	No
Secondary	Higher Random Glucose Associated With Treatment Choice at 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	No
Secondary	Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at 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	No
Secondary	Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at 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	No
Secondary	Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at 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	No
Secondary	Changes in HbA1c From Baseline to Month 24	Changes in HbA1c From Baseline to Month 24	Baseline, Month 24	No
Secondary	Percentage of Patients Achieving HbA1c Concentration <7.0% at 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	No
Secondary	Percentage of Patients Achieving HbA1c Concentration <6.5% at 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	No
Secondary	Changes in Weight From Baseline to Month 24	Changes in Weight From Baseline to Month 24	Baseline, Month 24	No
Secondary	Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months	Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months	Baseline to Month 24	Yes
Secondary	Incidence of Hypoglycemia Between Baseline and 24 Months	Incidence of Hypoglycemia between Baseline and 24 Months	Baseline to Month 24	Yes
Secondary	Reasons for Discontinuation of Baseline Regimen	Reasons for Discontinuation of Baseline Regimen	Baseline to Month 24	No
Secondary	Factors Associated With Treatment Change in Insulin Cohort	Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort	Baseline to Month 24	No
Secondary	Factors Associated With Treatment Change in Exenatide BID Cohort	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	No
Secondary	Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months	Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months	Baseline to Month 24	No
Secondary	Number of Contacts With Health Care Providers Between Baseline and 24 Months	Number of contacts with Health Care Providers Between Baseline and 24 Months	Baseline to Month 24	No
Secondary	Percentage of Patients Hospitalized Between Baseline and 24 Months	Percentage of Patients Hospitalized Between Baseline and 24 Months	Baseline to Month 24	Yes

External Links

•   Lilly Clinical Trial Registry