DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01817569

Completed

Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

46

Recruiting sites

—

Enrollment

2,948

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT01817569
Org study IDD5550C00001
Secondary IDEUPAS19606ENCePP

Timeline

Milestones

Study start2011-02-13actual
Study first posted2013-03-25estimated
Primary completion2019-10-03actual
Study completion2019-10-03actual
Last update posted2020-07-20actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Patients are eligible to be included in the study if they meet all of the following criteria: The patient who is diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta. The patient follows the PI of Byetta.

Eligibility criteria

- Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.

Endpoints (6)

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

Cardiometabolic biomarkers
2
Weight & body composition
1
Glycemic / diabetes
1
Patient-reported / QoL
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Mean change in weight.

Time frame:3 years

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Mean change of HbA1c.

Time frame:3 years

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Mean change in blood pressure.

Time frame:3 years.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean change in lipid metabolism.

Time frame:3 years

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs).

Time frame:3 years

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Adverse event incidence.

Time frame:3 years

Treatment-emergent AEs (any)

event count, event

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.