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CompletedPhase 2

Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents

An Exploratory Study of the Safety of Substituting Exenatide for Insulin in Patients With Type 2 Diabetes Who Have Been Using Insulin in Combination With Oral Antidiabetic Therapy

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

5

Recruiting sites

Enrollment

49

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 27-40HbA1c ≤10.5%

Primary endpoint

HbA1c, 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 IDNCT00099333
Org study IDH8O-MC-GWAK

Timeline

Milestones

Study first posted2004-12-13estimated
Last update posted2015-02-23estimated
Study start2004-02 (month precision)
Primary completion2005-08actual (month precision)
Study completion2005-08actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age35 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Patients have been treated with insulin for >=3 months up to 12 years.
HbA1c <=10.5%.
Body mass index (BMI) between 27 kg/m2 and 40 kg/m2.

Exclusion criteria

Patients previously received exenatide or GLP-1 analogs.
Patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.

Endpoints (1)

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.

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16

Time frame:Baseline, Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Publications (2)

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.