DelfaGLP-1 Atlas

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CompletedPhase 4

A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

A Randomized, Double-Blind, Crossover Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

19

Recruiting sites

—

Enrollment

102

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7-11%

Primary endpoint

•Postprandial glucose

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 IDNCT00477581
Org study IDBCA403

Timeline

Milestones

Study first posted2007-05-23estimated
Last update posted2015-08-26estimated
Study start2007-05 (month precision)
Primary completion2007-09actual (month precision)
Study completion2007-09actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Treatment with metformin for at least 2 months
•Has HbA1c 7.0% to 11.0%, inclusive, at screening
•Body mass index (BMI)25 kg/m^2 to 45 kg/m^2, inclusive
•List of medications that are not allowed or the patient has been on stable treatment for at least 2 months:
–Hormone replacement therapy (female subjects)
–Oral contraceptives (female subjects)
–Antihypertensive agents
–Lipid-lowering agents
–Thyroid replacement therapy

Exclusion criteria

•Has been treated with exenatide (BYETTA®) or any DPP-4 inhibitor prior to screening
•Received any study medication or participated in any type of clinical trial within 30 days prior to screening
•Has donated blood within 60 days of screening visit or is planning to donate blood during the study
•Treated with any of the following medications:
–Sulfonylurea or Thiazolidinedione within 3 months of screening;
–Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)within 30 days of screening;
–Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 6 months of screening;
–Drugs that directly affect gastrointestinal motility, including but not limited to, anticholinergics, macrolide antibiotics, dopamine antagonists, opioids, and Reglan®(metoclopramide);
–Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption;

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

Effect of Exenatide on postprandial glucose

Time frame:28 days

Postprandial glucose

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Assessment of effect of exenatide to the effect of sitagliptin the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles

Time frame:28 days

descriptive

componentsPostprandial glucose, C-peptide AUC, Triglycerides, change

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.