GLP-1 Peptide Atlas, by Delfa

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CompletedPhase 3

Safety and Efficacy of Exenatide as Monotherapy

Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

233

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 6.5-10%

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 IDNCT00381342

Org study IDH8O-MC-GWBJ

Timeline

Milestones

Study first posted2006-09-27estimated

Last update posted2015-02-23estimated

Study start2006-09 (month precision)

Primary completion2007-09actual (month precision)

Study completion2007-09actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes

•Treating diabetes with diet and exercise

•HbA1c between 6.5% and 10.0%, inclusive

•Body Mass Index (BMI) between 25 kg/m^2 and 45 kg/m^2, inclusive

Exclusion criteria

•Have previously completed or withdrawn from this study

•Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

•Have been treated with any antidiabetic agent

•Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening

•Are currently treated with any of the following excluded medications: * drugs that directly affect gastrointestinal motility; * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study

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

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight from Baseline to Week 24

Time frame:Baseline, Weeks 4, 8, 12, 16, and 24

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less

Time frame:Baseline, Weeks 4, 8, 12, 16, 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting serum glucose (FSG) from Baseline to Week 24

Time frame:Baseline, Weeks 4, 8, 12, 16, and 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in glucose measurements from Baseline to Week 24

Time frame:Baseline, Weeks 4, 8, 12, 16, 24

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Changes in beta-cell function and insulin sensitivity from Baseline to Week 24

Time frame:Baseline, Weeks 4, 8, 12, 16, and 24

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Changes in fasting and 30, 60, 120 and 180-minute glucose measurements

Time frame:Immediately before glucose load, then 30, 60, 120, and 180 minutes post

Postprandial glucose

change from baseline, improvement

Publications (3)

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

Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index.
Postgraduate medicine2012 Jul (month)PMID22913891doi:10.3810/pgm.2012.07.2567via clinicaltrials gov reference derived + pubmed nct search
Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.
Diabetes, obesity & metabolism2012 Jun (month)PMID22236356doi:10.1111/j.1463-1326.2012.01561.xvia clinicaltrials gov reference derived + pubmed nct search
Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study.
Clinical therapeutics2008 Aug (month)PMID18803987doi:10.1016/j.clinthera.2008.08.006via CT.gov reference

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.