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CompletedResults posted

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

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

Lead sponsor

AstraZeneca

Assets

Exenatide / GLP-1 / incretin class catch-all

Listed sites

96

Recruiting sites

—

Enrollment

2,515

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Estimates of Probability to Remain on Initial Injectable Treatment at 12

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00635492
Org study IDH8O-EW-B005

Timeline

Milestones

Study first posted2008-03-13estimated
Results first posted2014-07-09estimated
Last update posted2015-04-09estimated
Study start2008-01 (month precision)
Primary completion2011-12actual (month precision)
Study completion2011-12actual (month precision)

Assets

Investigational agents

ExenatideGLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

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.

Eligibility 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.

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
7
Glycemic / diabetes
6
Safety / tolerability / PK
3
Weight & body composition
2
Cardiovascular outcomes
1
Cardiometabolic biomarkers
1
Patient-reported / QoL
1

Cardiovascular outcomes

1 endpoint
Secondary/protocol endpoint

Percentage of Patients Hospitalized Between Baseline and 24 Months

Time frame:Baseline to Month 24

All-cause hospitalization

threshold achievement, event

Posted result

GroupValue (number), percentage of patients95% CI
Exenatide BIDLast 6 months prior to baseline4.7—
Baseline to 24 months4.3—
InsulinLast 6 months prior to baseline6.4—
Baseline to 24 months7.8—

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline

Time frame:Baseline

descriptive

Posted result

GroupValue (mean), kg/m^295% CI
Exenatide BID35.31.13 – 1.19
Insulin29.7—
Odds Ratio (OR)1.1695% CI1.13 – 1.19p<0.0001Regression, Logistic

Body Mass Index (BMI) - 1kg/m² higher

Secondary/protocol endpoint

Changes in Weight From Baseline to Month 24

Time frame:Baseline, Month 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Exenatide BID-3.22—
Insulin2.16—

Glycemic / diabetes

6 endpoints
Secondary/protocol endpoint

Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline

Time frame:Baseline

descriptive

LOINC 4548-4

Posted result

GroupValue (mean), percent of hemoglobin95% CI
Exenatide BID8.4—
Insulin9.2—
Odds Ratio (OR)0.7795% CI0.69 – 0.86p<0.0001Regression, Logistic

Most recent HbA1c at baseline - 1% higher.

Secondary/protocol endpoint

Higher Random Glucose Associated With Treatment Choice at Baseline

Time frame:6 months prior to Baseline

descriptive

Posted result

GroupValue (mean), mmol/L95% CI
Exenatide BID10.37—
Insulin12.13—
Odds Ratio (OR)0.9495% CI0.90 – 0.99p0.0141Regression, Logistic

Random blood glucose - 1 mmol/L higher

Secondary/protocol endpoint/low confidence

Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline

Time frame:4 weeks prior to Baseline

descriptive

Posted result

GroupValue (mean), tests/week95% CI
Exenatide BID9.28—
Insulin9.91—
Odds Ratio (OR)0.9895% CI0.96 – 0.99p0.0107Regression, Logistic

Blood glucose self-monitoring - 1 test/week more

Secondary/protocol endpoint

Changes in HbA1c From Baseline to Month 24

Time frame:Baseline, Month 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percentage of total hemoglobin95% CI
Exenatide BID-1.03—
Insulin-1.71—
Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24

Time frame:Month 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of patients95% CI
Exenatide BID26.9—
Insulin28.5—
Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24

Time frame:Month 24

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of patients95% CI
Exenatide BID12.5—
Insulin10.7—

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline

Time frame:Baseline

LDL-C, change

descriptive

LOINC 13457-7

Posted result

GroupValue (mean), mmol/L95% CI
Exenatide BID2.82—
Insulin3.00—
Odds Ratio (OR)0.8395% CI0.72 – 0.96p0.0138Regression, Logistic

LDL cholesterol - 1 mmol/L higher at baseline

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Disinhibited Eating Associated With Treatment Choice at Baseline

Time frame:Baseline

descriptive

Posted result

GroupValue (mean), units on a scale95% CI
Exenatide BID43.52—
Insulin34.38—
Odds Ratio (OR)1.0595% CI1.01 – 1.10p0.0083Regression, Logistic

Diabetes Health Profile - 18 (DHP-18) subscale disinhibited eating - Yes vs. No

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months

Time frame:Baseline to Month 24

event count, event

Posted result

GroupValue (number), percentage of patients95% CI
Exenatide BID29.4—
Insulin5.0—
Secondary/protocol endpoint

Incidence of Hypoglycemia Between Baseline and 24 Months

Time frame:Baseline to Month 24

Documented hypoglycemia

event count, event

Posted result

GroupValue (number), percentage of patients95% CI
Exenatide BID17.5—
Insulin35.2—
Secondary/protocol endpoint

Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months

Time frame:Baseline to Month 24

event count, descriptive

Posted result

GroupValue (number), percentage of patients95% CI
Exenatide BIDLast 6 months prior to baseline94.4—
Baseline to 24 months90.4—
InsulinLast 6 months prior to baseline94.1—
Baseline to 24 months92.3—

Other clinical outcomes

7 endpoints
Primary/protocol endpoint/low confidence

Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.

Time frame:Month 24

time to event, event

Posted result

GroupValue (number), probability (%)95% CI
Exenatide BIDEstimate at 24 months53.950.8 – 57.0
Estimate at 12 months67.865.0 – 70.6
InsulinEstimate at 24 months60.657.7 – 63.5
Estimate at 12 months70.668.0 – 73.1
Secondary/protocol endpoint

Older Age Associated With Treatment Choice at Baseline

Time frame:Baseline

categorical status, descriptive

Posted result

GroupValue (mean), years95% CI
Exenatide BID58.1—
Insulin63.7—
Odds Ratio (OR)0.9695% CI0.95 – 0.97p<0.0001Regression, Logistic

Age - 1 year older

Secondary/protocol endpoint

Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline

Time frame:Baseline

descriptive

Posted result

GroupValue (number), participants95% CI
Exenatide BIDMissing12—
No131—
Yes910—
Unknown124—
InsulinMissing1—
No237—
Yes905—
Unknown172—
Odds Ratio (OR)1.6795% CI1.13 – 2.46p0.0193Regression, Logistic

Receipt of diet/exercise advice - Yes vs. No

Secondary/protocol endpoint

Reasons for Discontinuation of Baseline Regimen

Time frame:Baseline to Month 24

categorical status, descriptive

Posted result

GroupValue (number), number of patients95% CI
Exenatide BIDInadequate response170—
Adverse event91—
Patient decision69—
Non compliance9—
Cannot afford medication4—
Other50—
InsulinInadequate response87—
Adverse event11—
Patient decision15—
Non compliance3—
Cannot afford medication1—
Other38—
Secondary/protocol endpoint

Factors Associated With Treatment Change in Insulin Cohort

Time frame:Baseline to Month 24

descriptive

Posted result

GroupValue (number), hazard ratio95% CI
Insulin CohortHbA1c (%) at baseline1.1181.062 – 1.177
DHP barriers to activity subscale at baseline0.9600.937 – 0.985
Gastrointestinal symptoms: yes vs. no at baseline2.5321.698 – 3.777
Insulin regimen: basal/bolus vs. long-acting only0.4370.303 – 0.630
Insulin regimen: mixtures vs. long-acting only0.6760.523 – 0.874
Insulin regimen: other vs. long-acting only0.5490.175 – 1.718
Insulin regimen: short-acting only vs. long-actin2.1641.681 – 2.785
Hazard Ratio (HR)1.11895% CI1.062 – 1.177p<0.0001Regression, Cox

HbA1c (%) at baseline

Hazard Ratio (HR)0.96095% CI0.937 – 0.985p0.001Regression, Cox

DHP barriers to activity subscale at baseline

Hazard Ratio (HR)2.53295% CI1.698 – 3.777p<0.001Regression, Cox

Gastrointestinal symptoms: yes vs. no at baseline

Hazard Ratio (HR)0.43795% CI0.303 – 0.630p<0.001Regression, Cox

Insulin regimen: basal/bolus vs. long-acting only

Hazard Ratio (HR)0.67695% CI0.523 – 0.874p0.003Regression, Cox

Insulin regimen: mixtures vs. long-acting only

Hazard Ratio (HR)0.54995% CI0.175 – 1.718p0.303Regression, Cox

Insulin regimen: other vs. long-acting only

Hazard Ratio (HR)2.16495% CI1.681 – 2.785p<0.001Regression, Cox

Insulin regimen: short-acting only vs. long-acting only

Secondary/protocol endpoint

Factors Associated With Treatment Change in Exenatide BID Cohort

Time frame:Baseline to Month 24

descriptive

Posted result

GroupValue (number), hazard ratio95% CI
Exenatide BIDGastro intestinal symptoms: yes vs no at baseline1.4631.043 – 2.053
EQ-5D index value at baseline0.6010.432 – 0.834
Hazard Ratio (HR)1.46395% CI1.043 – 2.053p0.028Regression, Cox

GI symptoms: yes vs. no at baseline

Hazard Ratio (HR)0.60195% CI0.432 – 0.834p0.002Regression, Cox

EQ-5D index value at baseline

Secondary/protocol endpoint

Number of Contacts With Health Care Providers Between Baseline and 24 Months

Time frame:Baseline to Month 24

event count, descriptive

Posted result

GroupValue (mean), number of contacts95% CI
Exenatide BIDLast 6 months prior to baseline7.17—
Baseline to 24 months19.00—
InsulinLast 6 months prior to baseline7.64—
Baseline to 24 months24.58—

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.