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Completed

Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

3

Recruiting sites

Enrollment

41

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 IDNCT00622323
Org study IDH8O-PH-B006

Timeline

Milestones

Study first posted2008-02-25estimated
Last update posted2016-10-26estimated
Study start2008-02 (month precision)
Primary completion2009-09actual (month precision)
Study completion2009-09actual (month precision)

Assets

Investigational agents

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

Male and female patients at least 18 years of age and diagnosed with type 2 diabetes mellitus treated in an ambulatory care setting and who are taking metformin, a sulfonylurea, or a combination of metformin and sulfonylurea, but have not achieved adequate glycemic control. Female patients eligible of becoming pregnant are required to have some form of contraception while participating in the study.

Inclusion criteria

are male or female outpatients at least 18 years of age
provide written consent to the release of their data after being informed of the study
diagnosed with type 2 diabetes mellitus and are taking metformin, or a sulfonylurea or both
are reliable, and agree to keep all appointments for clinic visits, complete tests and procedures as may be required by the attending physician in the course of routine clinical care
are treated with exenatide according to the approved Product Insert, as prescribed by the investigator in the routine care of the patient

Exclusion criteria

are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug.
are currently taking insulin.
are pregnant or have intentions of becoming pregnant within the duration of the study.
are the investigators or their immediate families. Immediate family is defined as the investigator's spouse, parents, natural or legally adopted child (including stepchild living in the investigator's household), grandparents, or grandchild. Employees of investigators are also not eligible.

Endpoints (2)

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
1
Safety / tolerability / PK
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

To evaluate the change from baseline to endpoint in HbA1c and body weight of Filipino patients with type 2 diabetes mellitus treated with exenatide who are taking metformin and/or a sulfonylurea but have not achieved adequate glycemic control.

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

To determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, that would occur among Filipino patients with type 2 diabetes and inadequate glycemic control treated with exenatide

Time frame:12 weeks

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.