DelfaGLP-1 Atlas

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Bydureon

CompletedPhase 4Results posted

A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.

A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in Patients With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

15

Recruiting sites

—

Enrollment

110

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious 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 IDNCT02533453
Org study IDD5551L00018

Timeline

Milestones

Study first posted2015-08-26estimated
Study start2016-01-28actual
Primary completion2016-12-07actual
Study completion2016-12-07actual
Last update posted2019-05-31actual
Results first posted2019-05-31actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age19 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female, 19-75 years of age
•diagnosed with type 2 diabetes mellitus
•Patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies;
–Metformin
–Sulphonylurea
–Thiazolidinedione
–Metformin and sulphonylurea
–Metformin and thiazolidinedione

Exclusion criteria

•Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following medications:

1. Alpha glucosidase inhibitor or meglitinide within 30 days of screening;

2. Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;

3. DPP-4 inhibitors within 30 days of screening;

4. Regular use (> 14 days) of drugs that directly affect gastrointestinal motility within 3 months of screening;

5. Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of screening;

6. GLP-1 receptor agonist except exenatide within 3 months of screening;

•diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis;
•type 2 diabetes by beta-cell dysfunction requiring insulin treatment
•Has ever used exenatide
•Pregnant or breast feeding patients
•Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the upper limit of normal
•End-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min)

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

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

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in Body Weight

Time frame:baseline and 12/24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
12/24 Weeks Treatment-0.95—

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in HbA1c

Time frame:baseline and 12/24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percentage of Hba1c95% CI
12/24 Weeks Treatment-1.21—
Secondary/protocol endpoint

Change in Fasting Plasma Gloucose

Time frame:baseline and 12/24 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mg/dL95% CI
12/24 Weeks Treatment-34.2—

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint/low confidence

Change in Vital Sign

Time frame:baseline and 12/24 weeks

change from baseline, improvement

Posted result

GroupValue (mean), mmHg95% CI
12/24 Weeks TreatmentSBP-3.35—
DBP-0.15—

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Evaluation of "Subjective Improvement of Main Indication"

Time frame:baseline and 12/24 weeks

PGI, change

categorical status, improvement

Posted result

GroupValue (number), participants95% CI
12/24 Weeks TreatmentImproved84—
Slightly improved11—
Unchanged6—
Aggravated1—
unable to evaluate1—

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)

Time frame:baseline and 12/24 weeks

Treatment-emergent AEs (any)

descriptive

componentsTreatment-emergent AEs (any), Serious AEs (any)

Posted result

GroupValue (number), percentage of participants95% CI
12/24 Weeks Treatmentrate of all AEs52.942.9 – 62.6
rate of all SAEs3.81.04 – 9.38

Publications (10)

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.