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Completed

Clinical Outcomes of Exenatide Versus Basal Insulin

Evaluation of the Clinical and Economic Outcomes Associated With Exenatide Versus Basal Insulin in People With Type 2 Diabetes

Lead sponsor

AstraZeneca

Assets

Exenatide / GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

18,000

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoints

HbA1c, changeBody weight, absolute change (kg)Changes from baseline in composite outcomes of HbA1c<=7.0% and weight reduction (HbA1c <7.0% achievement, Body weight, % change)

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 IDNCT02987348
Org study IDD5551R00010

Timeline

Milestones

Study start2015-06-30actual
Primary completion2015-06-30actual
Study completion2015-06-30actual
Study first posted2016-12-08estimated
Last update posted2017-03-29actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

This is a non-interventional study based on secondary data analysis. Patients received treatment under their standard care, no intervention was given by the study investigator. Patients will be identified and included in the study if they were defined by CPRD as being of acceptable research quality and classified as having type 2 diabetes who initiated exenatide or basal insulin as monotherapy or in combination with one or more other oral glucose-lowering therapies between January 2009 and December 2014. Exenatide once weekly (Bydureon) and exenatide twice daily (Byetta) are both investigated, and compared with matched basal insulin cohort. Patients will be excluded if they had received prior injectable diabetes therapy and had less than 90 days continuous exposure to the study drugs.

Inclusion criteria

Type 2 diabetic patients who initiated therapy with exenatide or basal insulin between 2009 and 2014.

Exclusion criteria

prior injectable diabetes therapy
less than 365 days between the latter of the patient's CPRD registration date/practice up-to-standard date and study index date.
less than 90 days continuous exposure to Exenatide or basal insulin

Endpoints (4)

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

Glycemic / diabetes
2
Weight & body composition
1
Other clinical outcomes
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Changes from baseline in weight (kg)

Time frame:6, 12 and 24 months

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Changes from baseline in HbA1c (%)

Time frame:6, 12 and 24 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Changes from baseline in composite outcomes of HbA1c<=7.0% and weight reduction

Time frame:6, 12 and 24 months

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, % change

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint/low confidence

Health care utilization

Time frame:12 months

descriptive

Publications (1)

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 tableno registry results posted yet

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.