DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT00359879

CompletedPhase 3

Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

15

Recruiting sites

—

Enrollment

377

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7.1-10%

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 IDNCT00359879
Org study IDH8O-CR-GWBH

Timeline

Milestones

Study first posted2006-08-03estimated
Last update posted2015-02-23estimated
Study start2006-09 (month precision)
Primary completion2007-07actual (month precision)
Study completion2007-07actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes.
•Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD.
•HbA1c between 7.1% and 10.0%, inclusive.
•Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2

Exclusion criteria

•Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
•Have characteristics contraindicating metformin, SU, or TZD use.
•Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
•Have used any prescription drug to promote weight loss within 3 months prior to screening.
•Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility

Endpoints (4)

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
3
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight from Baseline to Week 12, and if measured, at each visit

Time frame:Baseline, Weeks 4, 8, 12

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit

Time frame:Baseline, Weeks 4, 8, 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12

Time frame:Baseline, Weeks 4, 8, 12

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 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.