GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

456

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c ≤11%

Primary endpoints

•HbA1c, change•Body weight, absolute change (kg)•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 IDNCT00111540

Org study ID2993-119

Timeline

Milestones

Study first posted2005-05-24estimated

Last update posted2015-02-23estimated

Study start2002-11 (month precision)

Primary completion2006-09actual (month precision)

Study completion2006-09actual (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

•The subject has an HbA1c value <=11.0%

•The subject has a body mass index (BMI) of 25 kg/m^2 to 45 kg/m^2, inclusive

Exclusion criteria

•Is currently treated with certain medications, including exogenous insulin

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

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

1 endpoint

Primary/protocol endpoint

Change in body weight from Visit 1 to each protocol visit

Time frame:Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit

Time frame:Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Change in fasting plasma glucose from Visit 1 to each protocol visit

Time frame:Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

1 endpoint

Primary/protocol endpoint

Change in lipids from Visit 1 to each protocol visit

Time frame:Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

change from baseline, improvement

Publications (5)

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

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
Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years.
Current medical research and opinion2008 Jan (month)PMID18053320doi:10.1185/030079908x253870via CT.gov reference
The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes.
Diabetes technology & therapeutics2007 Aug (month)PMID17705687doi:10.1089/dia.2006.0024via clinicaltrials gov reference derived + pubmed nct search
Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials.
Clinical therapeutics2007 Jan (month)PMID17379054doi:10.1016/j.clinthera.2007.01.015via CT.gov reference
Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes.
Diabetes, obesity & metabolism2006 Jul (month)PMID16776751doi:10.1111/j.1463-1326.2006.00602.xvia 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.