DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02090673

Completed

Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

1,711

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 IDNCT02090673
Org study IDMB001-078

Timeline

Milestones

Study first posted2014-03-18estimated
Last update posted2015-08-20estimated
Study start2009-02 (month precision)
Primary completion2014-03actual (month precision)
Study completion2014-03actual (month precision)

Assets

Investigational agents

Exenatide

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

Primary care clinic, hospital and teaching hospitals

Inclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

•Male or female at least 18 years of age
•Patients who are to initiate Exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice
•Patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information

Exclusion criteria

•Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
•Are pregnant or have intentions of becoming pregnant within the duration of the study
•Contraindications

Endpoints (5)

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
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change from baseline to endpoint in Body weight

Time frame:Baseline (Day 1) and 12 or 24 weeks ± 4 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change from baseline to endpoint in Hemoglobin A1c (HbA1c)

Time frame:Baseline (Day 1) and 12 or 24 weeks ± 4 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline to endpoint in Fasting plasma glucose

Time frame:Baseline (Day 1) and 12 or 24 weeks ± 4 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

The proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients who are treated with Exenatide for type 2 diabetes mellitus

Time frame:At 12 weeks ± 4 weeks or 24 weeks ± 4 weeks

Treatment-emergent AEs (any)

descriptive

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

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from baseline to endpoint in subjective measures include improvement of main indication

Time frame:Baseline (Day 1) and 12 or 24 weeks ± 4 weeks

change from baseline, improvement

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.