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Delfa

← All trials/NCT00099619

CompletedPhase 3

Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

Efficacy of Exenatide Compared With Insulin Glargine in Patients With Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

26

Recruiting sites

-

Actual enrollment

138

Study population

Type 2 diabetes

Eligibility highlights

•BMI 25-40•HbA1c 7.1-11%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00099619
Org study IDH8O-MC-GWAO

Timeline

Milestones

Study first posted2004-12-20estimated
Last update posted2015-02-23estimated
Study start2004-09 (month precision)
Primary completion2005-08actual (month precision)
Study completion2005-08actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age30 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

Main Inclusion Criteria:

•Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.
•HbA1c between 7.1% and 11.0%, inclusive.
•Insulin therapy should be the next appropriate step of diabetes treatment.
•Body Mass Index (BMI) >25 kg/m2 and <40 kg/m2.

Main Exclusion Criteria:

•Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.
•Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.

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
Patient-reported / QoL
1

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.

Time frame:Baseline, Week 16, Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change in patient-reported outcomes from Baseline to the end of each 16-week period

Time frame:Baseline, Week 16, Week 32

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 6, 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 6, 2026 snapshot.