DelfaGLP-1 Atlas

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CompletedPhase 3

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

51

Recruiting sites

—

Enrollment

182

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7.1-10%

Primary endpoints

•HbA1c, change•Fasting glucose, 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 IDNCT00099320
Org study IDH8O-MC-GWAP

Timeline

Milestones

Study first posted2004-12-13estimated
Last update posted2015-02-23estimated
Study start2004-05 (month precision)
Primary completion2005-08actual (month precision)
Study completion2005-08actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
•HbA1c between 7.1% and 10.0%, inclusive.
•Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.

Exclusion criteria

•Patient previously in a study using exenatide or GLP-1 analogs.
•Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
•Treated with oral insulin within 3 months of screening.

Endpoints (7)

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
5
Weight & body composition
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight from Baseline to Week 16

Time frame:Baseline, Week 16

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between

Time frame:Baseline, Week 4, Week 8, Week 12, Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose

Time frame:Baseline, Week 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of subjects reaching the target HbA1c (<7%)

Time frame:Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose

Time frame:Baseline, Week 16

change from baseline, improvement

componentsFasting glucose, change, Postprandial glucose

Secondary/protocol endpoint

Changes in beta cell function and insulin sensitivity between Baseline and Week 16

Time frame:Baseline, Week 16

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Changes in lipids between Baseline and Week 16

Time frame:Baseline, Week 16

change from baseline, improvement

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.