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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: exenatide
* Drug: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>exenatide | Drug: exenatide<br>* subcutaneous injection, 5mcg or 10mcg, twice a day<br>* Other names: Byetta;|
| 2<br>insulin | Drug: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Changes in HbA1c From Baseline to Month 24 | Changes in HbA1c From Baseline to Month 24 | Baseline, Month 24 | 
| 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 | 
| 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 | 
| Changes in Weight From Baseline to Month 24 | Changes in Weight From Baseline to Month 24 | Baseline, Month 24 | 
| Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months | Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months | Baseline to Month 24 | 
| Incidence of Hypoglycemia Between Baseline and 24 Months | Incidence of Hypoglycemia between Baseline and 24 Months | Baseline to Month 24 | 
| Reasons for Discontinuation of Baseline Regimen | Reasons for Discontinuation of Baseline Regimen | Baseline to Month 24 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Percentage of Patients Hospitalized Between Baseline and 24 Months | Percentage of Patients Hospitalized Between Baseline and 24 Months | Baseline to Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, insulin, exenatide, Byetta, Amylin, Lilly