DelfaGLP-1 Atlas

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CompletedPhase 3

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

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

14

Recruiting sites

—

Enrollment

466

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 21-35•HbA1c 7.1-11%

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 IDNCT00324363
Org study IDH8O-MC-GWBA

Timeline

Milestones

Study first posted2006-05-11estimated
Last update posted2015-02-23estimated
Study start2006-01 (month precision)
Primary completion2007-04actual (month precision)
Study completion2007-04actual (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 a stable dose of one of the following for at least 3 months prior to screening: * >=1000 mg/day immediate-release metformin; or metformin >=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy.
•HbA1c between 7.1% and 11.0%, inclusive.
•Body Mass Index (BMI) >21 kg/m^2 and <35 kg/m^2.

Exclusion criteria

•Have participated in this study previously, or any other study using exenatide or GLP-1 analogs.
•Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening.
•Have characteristics contraindicating metformin or sulfonylurea use.
•Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.
•Have used drugs for weight loss within 1 month of 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
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas.

Time frame:16 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

To compare exenatide and placebo groups with respect to: *safety and tolerability; *proportion of patients achieving HbA1c<=7%; *body weight; *incidence and rate of hypoglycemic events; *glucose measurements

Time frame:16 weeks

descriptive

componentsTreatment-emergent AEs (any), HbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia, Fasting glucose, change

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.